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Elterman D, Murphy M, Krlin R, Levine R, Yaklic J, Michaels J, Bleier J, Paquette I, Farmer R, Xavier K, Papi B, Wu M, Siproudhis L. Post-Market Study Evaluating Performance of the Rechargeable InterStim™ Micro System in Fecal Incontinence Patients. Int Urogynecol J 2025; 36:913-921. [PMID: 40186665 DOI: 10.1007/s00192-025-06127-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2024] [Accepted: 03/10/2025] [Indexed: 04/07/2025]
Abstract
INTRODUCTION AND HYPOTHESIS To confirm the performance and safety of the rechargeable sacral neuromodulation system (InterStim™ Micro) through 2-year follow-up, we report results from the fecal incontinence (FI) cohort through 6-month follow-up. METHODS Eligible patients were enrolled following successful therapy evaluation and implant. Participants completed bowel diaries and questionnaires at baseline, 3, and 6 months post-implant. The primary objective was improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline. Safety was evaluated by collection of reportable adverse events (AE). RESULTS Of 53 patients implanted, 90.6% were female and the mean (± SD) age was 58 ± 11 years. There was a statistically significant improvement in CCIS at 3 months vs baseline, with a mean change of -4 ± 3.7 (p < 0.001, n = 52). This improvement was maintained at 6 months, with a mean change of -4.0 ± 3.58 (n = 52). The mean change in Fecal Incontinence Quality of Life (FIQoL) at 3 months was 3.2 ± 2.8 (n = 52) and 3.6 ± 2.9 (n = 53) at 6 months. On the Patient Global Impression of Improvement (PGI-I), 94% (n = 52) and 90.6% (n = 53) of participants reported their condition was better at 3- and 6-month follow-up compared to baseline, respectively. The incidence of device-, procedure-, or therapy-related AEs in enrolled participants was 18.9% (10/53); among these was one serious related AE. There were no unanticipated adverse device effects. CONCLUSIONS The primary objective of the FI cohort was met, with statistically significant improvement in CCIS and patient-reported outcomes. These data confirm clinical performance and safety through 6 months post-implant. CLINICAL TRIAL REGISTRATION NCT04506866.
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Affiliation(s)
- Dean Elterman
- Division of Urology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.
| | - Margarita Murphy
- Colon Surgeons of Charleston, Mount Pleasant, SC, USA
- Orlando Health, Orlando, FL, USA
| | - Ryan Krlin
- Department of Urology, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | | | - Jerome Yaklic
- University of Texas Medical Branch Health, Galveston, TX, USA
| | - Jodi Michaels
- Center for Continence Care, Minnesota Urology, Woodbury, MN, USA
| | | | - Ian Paquette
- University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Russell Farmer
- University of Louisville School of Medicine, Louisville, KY, USA
| | - Keith Xavier
- Urology Partners of North Texas, Arlington, TX, USA
| | | | | | - Laurent Siproudhis
- Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou, Rennes, France
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Kastelberg BS, Donnelly MC, Smallfield GB, Sharp SP, Carucci LR, Klausner AP. A case of lead migration after sacral neuromodulation with erosion into the rectum. Urol Case Rep 2025; 58:102894. [PMID: 39687276 PMCID: PMC11648089 DOI: 10.1016/j.eucr.2024.102894] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2024] [Accepted: 11/25/2024] [Indexed: 12/18/2024] Open
Abstract
We present a case of a 73-year-old female with medication refractory overactive bladder treated with the InterStim® sacral neuromodulation device. Five months post implantation she developed drainage over the lead site and rectal bleeding. Evaluation identified lead migration with rectal perforation requiring surgical removal of the battery and lead. Post removal, the patient returned to baseline urinary symptoms with the development of de novo fecal incontinence. This is the third reported case of sacral neuromodulation lead migration causing rectal perforation in the literature, and the only case managed with endoscopic closure of the rectal defect.
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Affiliation(s)
- Bridget S. Kastelberg
- Division of Urology, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
| | - Madeline C. Donnelly
- Division of Urology, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
| | - George B. Smallfield
- Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
| | - Stephen P. Sharp
- Division of Colorectal Surgery, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
| | - Laura R. Carucci
- Department of Radiology, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
| | - Adam P. Klausner
- Division of Urology, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
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Katuwal B, Thorsen A, Kochar K, Bhullar R, King R, Drelichman ER, Mittal VK, Bhullar JS. Outcomes and efficacy of magnetic resonance imaging-compatible sacral nerve stimulator for management of fecal incontinence: A multi-institutional study. World J Radiol 2024; 16:32-39. [PMID: 38455883 PMCID: PMC10915907 DOI: 10.4329/wjr.v16.i2.32] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2023] [Revised: 11/24/2023] [Accepted: 02/02/2024] [Indexed: 02/23/2024] Open
Abstract
BACKGROUND Fecal incontinence (FI) is an involuntary passage of fecal matter which can have a significant impact on a patient's quality of life. Many modalities of treatment exist for FI. Sacral nerve stimulation is a well-established treatment for FI. Given the increased need of magnetic resonance imaging (MRI) for diagnostics, the InterStim which was previously used in sacral nerve stimulation was limited by MRI incompatibility. Medtronic MRI-compatible InterStim was approved by the United States Food and Drug Administration in August 2020 and has been widely used. AIM To evaluate the efficacy, outcomes and complications of the MRI-compatible InterStim. METHODS Data of patients who underwent MRI-compatible Medtronic InterStim placement at UPMC Williamsport, University of Minnesota, Advocate Lutheran General Hospital, and University of Wisconsin-Madison was pooled and analyzed. Patient demographics, clinical features, surgical techniques, complications, and outcomes were analyzed. Strengthening the Reporting of Observational studies in Epidemiology(STROBE) cross-sectional reporting guidelines were used. RESULTS Seventy-three patients had the InterStim implanted. The mean age was 63.29 ± 12.2 years. Fifty-seven (78.1%) patients were females and forty-two (57.5%) patients had diabetes. In addition to incontinence, overlapping symptoms included diarrhea (23.3%), fecal urgency (58.9%), and urinary incontinence (28.8%). Fifteen (20.5%) patients underwent Peripheral Nerve Evaluation before proceeding to definite implant placement. Thirty-two (43.8%) patients underwent rechargeable InterStim placement. Three (4.1%) patients needed removal of the implant. Migration of the external lead connection was observed in 7 (9.6%) patients after the stage I procedure. The explanation for one patient was due to infection. Seven (9.6%) patients had other complications like nerve pain, hematoma, infection, lead fracture, and bleeding. The mean follow-up was 6.62 ± 3.5 mo. Sixty-eight (93.2%) patients reported significant improvement of symptoms on follow-up evaluation. CONCLUSION This study shows promising results with significant symptom improvement, good efficacy and good patient outcomes with low complication rates while using MRI compatible InterStim for FI. Further long-term follow-up and future studies with a larger patient population is recommended.
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Affiliation(s)
- Binit Katuwal
- Department of Surgery, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States
| | - Amy Thorsen
- Department of Colon and Rectal surgery, Alina Health Abbott Northwestern Hospital, Minneapolis, MN 55407, United States
| | - Kunal Kochar
- Colon and Rectal Surgery, Advocate Illinois Masonic, Park Ridge, IL 60068, United States
| | - Ryba Bhullar
- Volunteer Student, Department of Research, Ascension Providence Hospital, Southfield, MI 48075, United States
| | - Ray King
- Colon and Rectal Surgery, University of Wisconsin, Madison, WI 53715, United States
| | - Ernesto Raul Drelichman
- General and Colorectal Surgery, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States
| | - Vijay K Mittal
- Department of Surgery, Department of Medical Education, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States
| | - Jasneet Singh Bhullar
- General and Colorectal Surgery, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States
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Luo C, Wei D, Pang K, Mei L, Chen Y, Niu X. Is percutaneous tibial nerve stimulation (PTNS) effective for fecal incontinence (FI) in adults compared with sham electrical stimulation? A meta-analysis. Tech Coloproctol 2024; 28:37. [PMID: 38401006 DOI: 10.1007/s10151-024-02910-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2023] [Accepted: 01/27/2024] [Indexed: 02/26/2024]
Abstract
BACKGROUND Sacral nerve neuromodulation (SNM) has been considered the optimal second-line treatment for fecal incontinence (FI). However, SNM involves high cost and requires highly skilled operators. Percutaneous tibial nerve stimulation (PTNS) has emerged as an alternative treatment modality for FI, yielding varying clinical outcomes. We conducted this meta-analysis to evaluate the effectiveness and safety of PTNS compared to sham electrical stimulation for FI. METHODS PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies from May 12, 2012 to May 12, 2022. RESULTS Four randomized controlled studies were included in this review, involving a total of 439 adult patients with FI (300 in the PTNS group and 194 in the sham electrical stimulation group). Our meta-analysis revealed that PTNS demonstrated superior efficacy in reducing weekly episodes of FI compared to the control groups (MD - 1.6, 95% CI - 2.94 to - 0.26, p = 0.02, I2 = 30%). Furthermore, a greater proportion of patients in the PTNS group reported more than a 50% reduction in FI episodes per week (RR 0.73, 95% CI 0.57-0.94, p = 0.02, I2 = 6%). However, no significant differences were observed in any domains of the FI Quality of Life (QoL) and St Mark's incontinence scores (MD - 2.41, 95% CI - 5.1 to 0.27, p = 0.08, I2 = 67%). Importantly, no severe adverse events related to PTNS were reported in any of the participants. CONCLUSIONS Our meta-analysis revealed that PTNS was more effective than sham stimulation in reducing FI episodes and led to a higher proportion of patients reporting more than a 50% reduction in weekly FI episodes.
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Affiliation(s)
- Can Luo
- Department of Gynecology and Obstetrics, West China Second Hospital, Sichuan University, Chengdu, China
- Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China
| | - Dongmei Wei
- Department of Gynecology and Obstetrics, West China Second Hospital, Sichuan University, Chengdu, China
- Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China
| | - Kaiyin Pang
- Department of Gynecology and Obstetrics, West China Second Hospital, Sichuan University, Chengdu, China
- Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China
| | - Ling Mei
- Department of Gynecology and Obstetrics, West China Second Hospital, Sichuan University, Chengdu, China
- Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China
| | - Yueyue Chen
- Department of Gynecology and Obstetrics, West China Second Hospital, Sichuan University, Chengdu, China
- Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China
| | - Xiaoyu Niu
- Department of Gynecology and Obstetrics, West China Second Hospital, Sichuan University, Chengdu, China.
- Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China.
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Martin S, O'Connor AD, Selvakumar D, Baraza W, Faulkner G, Mullins D, Kiff ES, Telford KJ, Sharma A. The Long-term Outcomes of Sacral Neuromodulation for Fecal Incontinence: A Single-Center Experience. Dis Colon Rectum 2024; 67:129-137. [PMID: 37738178 DOI: 10.1097/dcr.0000000000002937] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/24/2023]
Abstract
BACKGROUND Sacral neuromodulation is an effective treatment for fecal incontinence. OBJECTIVE To assess the long-term outcomes of sacral neuromodulation and establish the outcomes of patients with inactive devices. DESIGN This is an observational study of patients treated for >5 years. A positive outcome was defined as a more than 50% reduction in fecal incontinence episodes or improvement in a symptom severity score. Data were reviewed from a prospectively managed database. SETTINGS This study was conducted at a single tertiary referral center. PATIENTS Data from 74 patients (72 women) were available at long-term follow-up. MAIN OUTCOME MEASURES Bowel diary, St. Mark's incontinence score, and Manchester Health Questionnaire data were prospectively recorded at baseline, after percutaneous nerve evaluation, and at last follow-up. RESULTS Patients were analyzed in cohorts based on time since sacral neuromodulation implantation: group 1: 5 to 10 years (n = 20), group 2: >10 years (n = 35), and group 3: inactive sacral neuromodulation devices (n = 19). Median St. Mark's incontinence score and Manchester Health Questionnaire improved from baseline to last follow-up in group 1 ( p ≤ 0.05) and group 2 ( p ≤ 0.05), but in group 3, results returned to baseline levels at the last follow-up. Similarly, weekly fecal incontinence episodes improved in both active device groups at the last follow-up. However, in group 3, incontinence episodes were no different from baseline ( p = 0.722). Despite active devices, fecal urgency episodes increased at the last follow-up after >10 years since percutaneous nerve evaluation ( p ≤ 0.05). Complete continence was reported by 44% of patients, and at least a 50% improvement was seen in 77% of patients with active devices. LIMITATIONS This study is retrospective with some gaps in the available data at the last follow-up. CONCLUSIONS Sacral neuromodulation is an effective treatment for fecal incontinence in the long term, but all outcomes are adversely affected by device inactivity. Therefore, ongoing stimulation is required for continued benefit. See Video Abstract. RESULTADOS A LARGO PLAZO DE LA NEUROMODULACIN SACRA PARA LA INCONTINENCIA FECAL EXPERIENCIA DE UN SOLO CENTRO ANTECEDENTES:La neuromodulación sacra es un tratamiento eficaz para la incontinencia fecal.OBJETIVO:Este estudio tuvo como objetivo evaluar los resultados a largo plazo de la neuromodulación sacra y establecer los resultados de los pacientes con dispositivos inactivos.DISEÑO:Este es un estudio observacional de pacientes tratados durante más de 5 años. Un resultado positivo se definió como una reducción >50 % en los episodios de incontinencia fecal o una mejoría en la puntuación de gravedad de los síntomas. Los datos se revisaron a partir de una base de datos administrada prospectivamente.ENTERNO CLINICO:Este estudio se realizó en un solo centro de referencia terciario.PACIENTES:Los datos de 74 pacientes (72 mujeres) estaban disponibles en el seguimiento a largo plazo.PRINCIPALES MEDIDAS DE RESULTADO:Diario intestinal, puntuación de incontinencia de St. Mark y datos del Cuestionario de salud de Manchester se registraron prospectivamente al inicio, después de la evaluación de nervio periférico y en el último seguimiento.RESULTADOS:Los pacientes se analizaron en cohortes según el tiempo transcurrido desde la implantación de la neuromodulación sacra: Grupo 1: 5-10 años (n = 20), Grupo 2: >10 años (n = 35) y Grupo 3: dispositivos SNM inactivos (n = 19). La mediana de la puntuación de incontinencia de St. Mark y Questionnaire Cuestionario de salud de Manchester mejoraron desde el inicio hasta el último seguimiento en el Grupo 1 (p = < 0,05) y el Grupo 2 (p = < 0,05), pero en el Grupo 3 los resultados volvieron a los niveles iniciales en el último seguimiento. arriba. De manera similar, los episodios semanales de incontinencia fecal mejoraron en ambos grupos de dispositivos activos en el último seguimiento. Sin embargo, en el Grupo 3 los episodios de incontinencia no fueron diferentes de los basales (p = 0,722). A pesar de los dispositivos activos, los episodios de urgencia fecal aumentaron en el último seguimiento después de más de 10 años desde la evaluación del nervio periférico (p = < 0,05). Continencia completa se reportó en el 44 % de los pacientes, y al menos una mejora del 50 % en el 77 % con dispositivos activos.LIMITACIONES:Este estudio es retrospectivo con algunas vacíos en los datos disponibles en el último seguimiento.CONCLUSIONES:La neuromodulación sacra es un tratamiento eficaz para la incontinencia fecal a largo plazo, pero todos los resultados se ven afectados negativamente por la inactividad del dispositivo. Por lo tanto, se requiere estimulación continua para un beneficio continuo. (Traducción- Dr. Francisco M. Abarca-Rendon ).
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Affiliation(s)
- Sarah Martin
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
- Faculty of Biology, Medicine, and Health, The University of Manchester, Manchester, United Kingdom
| | - Alexander D O'Connor
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
- Faculty of Biology, Medicine, and Health, The University of Manchester, Manchester, United Kingdom
| | - Deepak Selvakumar
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
- Faculty of Biology, Medicine, and Health, The University of Manchester, Manchester, United Kingdom
| | - Wal Baraza
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
- Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Gemma Faulkner
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
| | - Domini Mullins
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
| | - Edward S Kiff
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
| | - Karen Jane Telford
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
- Faculty of Biology, Medicine, and Health, The University of Manchester, Manchester, United Kingdom
| | - Abhiram Sharma
- Department of Colorectal Surgery, Manchester University NHS Foundation Trust, Manchester, United Kingdom
- Faculty of Biology, Medicine, and Health, The University of Manchester, Manchester, United Kingdom
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Goudelocke C, Hill H, Major N, Couvaras A, Long A. A novel sacral neuromodulation protocol is associated with reduction in removal for device infection. Int Urogynecol J 2023; 34:2421-2428. [PMID: 37154899 DOI: 10.1007/s00192-023-05543-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/15/2023] [Accepted: 03/26/2023] [Indexed: 05/10/2023]
Abstract
INTRODUCTION AND HYPOTHESIS Sacral neuromodulation (SNM) has been established as an effective third-line therapy for non-obstructive urinary retention and urinary urgency-frequency syndrome. Device infection, ranging from 2-10%, is a severe complication usually necessitating device explanation. This study sought to demonstrate an infection protocol founded upon established device implantation risk factors and novel approaches to reduce the incidence of device infection, while maintaining good antibiotic stewardship following best practice statements. METHODS A single-surgeon protocol was enacted from 2013 to 2022. Preoperatively, nasal swabs were cultured from each patient. If positive for methicillin-resistant Staphylococcus aureus or methicillin-sensitive Staphylococcus aureus, preoperative treatment with intranasal mupirocin was employed. Preoperative cefazolin was administered in patients with negative cultures or MSSA-positive. All protocol patients were given chlorhexidine wipes before surgery and prepped with a chlorhexidine scrub followed by alcohol/iodine paint. Post-procedural antibiotics were not given. Pre-protocol patients from 2011 to 2013 served as controls. RESULTS Pre-protocol (n = 87) patients had a significantly higher rate of device infection compared to protocol patients (n = 444) in both the percentage of patients experiencing device infection (4.6% vs 0.9%, p = 0.01) and percentage of procedures associated with device infection (2.9% vs 0.5%, p < 0.05). A successful culture of the nares was achieved in 91.4% of protocol patients, with 11.6% MRSA-positive. Risk ratio for infection of pre-protocol/protocol patients was 0.19 (0.05-0.77) with odds ratio 5.1 (1.3-20.0). CONCLUSIONS Utilization of a novel SNM infection protocol tailored to a patient's preoperative MRSA colonization is associated with a reduction in the overall incidence of explant for device infection while avoiding prolonged postoperative antibiotic regimens. CLINICAL TRIAL REGISTRATION The study was initiated prior to January 18, 2017 and does not meet the definition of an applicable clinical trial (ACT) as defined in section 402 (J) of the US PHS Act.
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Affiliation(s)
- Colin Goudelocke
- Department of Urology, Ochsner Medical Center, 1514 Jefferson Hwy, New Orleans, LA, 70121, USA.
| | - Hayden Hill
- Department of Urology, Ochsner Medical Center, 1514 Jefferson Hwy, New Orleans, LA, 70121, USA
| | - Nicholas Major
- Department of Urology, Ochsner Medical Center, 1514 Jefferson Hwy, New Orleans, LA, 70121, USA
| | - Anastasia Couvaras
- Department of Urology, Ochsner Medical Center, 1514 Jefferson Hwy, New Orleans, LA, 70121, USA
| | - Amy Long
- Department of Urology, Erlanger Health Center, Chattanooga, TN, USA
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Luchristt D, Kawasaki A. Successful sacral neuromodulation treatment of refractory faecal incontinence in a patient with spina bifida and partial sacral agenesis. BMJ Case Rep 2023; 16:e254835. [PMID: 37669822 PMCID: PMC10481722 DOI: 10.1136/bcr-2023-254835] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/07/2023] Open
Abstract
A woman in her early 20s with a history of lumbosacral lipomyelomeningocele with associated partial sacral agenesis and tethered cord was referred for possible sacral neuromodulation treatment of her refractory faecal incontinence. Anorectal testing revealed a thinned and weakened anal sphincter complex with absent left-sided bulbocavernosus and anal wink reflexes.Through a two-stage approach, she underwent successful placement of a chronic tined quadripolar sacral nerve lead and implanted pulse generator. Despite significant distortion of normal bony anatomic landmarks, bilateral S3 and S4 foraminal entry was possible, with intraoperative motor and sensory testing providing key confirmation of appropriate lead placement. The patient had a substantial improvement in her baseline frequency and urgency with a near-complete resolution of faecal incontinence episodes during her test phase.
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Affiliation(s)
- Douglas Luchristt
- Obstetrics and Gynecology, Duke University School of Medicine, Durham, North Carolina, USA
| | - Amie Kawasaki
- Obstetrics and Gynecology, Duke University School of Medicine, Durham, North Carolina, USA
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de Codes LMG, de Jesus ACC, de Codes JJG, Ferreira RF, da Silva Beda Sacramento C, da Cruz IDM, de Castro Ribeiro Fidelis F, de Carvalho AL, Motta MP, de Oliveira Alves C, Netto EM, Santana GO. Anorectal Function and Clinical Characteristics Associated with Faecal Incontinence in Patients with Crohn's Disease. J Crohns Colitis 2023; 17:1252-1261. [PMID: 36951290 DOI: 10.1093/ecco-jcc/jjad048] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2022] [Indexed: 03/24/2023]
Abstract
BACKGROUND AND AIMS Faecal incontinence is an important complaint reported by patients with Crohn's disease [CD] and it is associated with several disease-related mechanisms, including anorectal functional disorders. This study aimed to assess the anorectal function and clinical characteristics to identify parameters associated with faecal incontinence in CD patients. METHODS This is a cross-sectional study of 104 patients with CD, aged 18 years or older, from a referral centre between August 2019 and May 2021. Patients responded to a specific questionnaire, and underwent medical record review, proctological examination and anorectal functional assessment with anorectal manometry. RESULTS Of the 104 patients, 49% were incontinent. Patients with incontinence had a lower mean resting pressure [43.5 vs 53.1 mmHg; p = 0.038], lower mean squeeze pressure [62.1 vs 94.1 mmHg; p = 0.036] and lower maximum rectal capacity [140 vs 180 mL; p < 0.001]. Faecal incontinence was also associated with disease activity [p < 0.001], loose stools [p = 0.02], perianal disease [p = 0.006], previous anoperineal surgery [p = 0.048] and number of anorectal surgeries [p = 0.036]. CONCLUSIONS This is the largest reported study describing manometric findings of Crohn's disease patients with and without faecal incontinence. Our results identified an association between faecal incontinence and functional disorders, in addition to clinical features in these patients. Functional assessment with anorectal manometry may help choose the best treatment for faecal incontinence in patients with CD.
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Affiliation(s)
- Lina Maria Góes de Codes
- Medicine and Health Science Postgraduate Program, Universidade Federal da Bahia, Salvador, Brazil; Department of Surgery, Hospital Universitário Professor Edgard Santos, Salvador, Brazil
| | | | | | | | | | | | | | | | - Marina Pamponet Motta
- Department of Gastroenterology, Hospital Universitário Professor Edgard Santos, Salvador, Brazil
| | | | - Eduardo Martins Netto
- Medicine and Health Science Postgraduate Program, Universidade Federal da Bahia, Salvador, Brazil
| | - Genoile Oliveira Santana
- Medicine and Health Science Postgraduate Program, Universidade Federal da Bahia, Salvador, Brazil; Department of Life Sciences, Universidade do Estado da Bahia, Salvador, Brazil
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Kasiri MM, Mittlboeck M, Dawoud C, Riss S. Technical and functional outcome after sacral neuromodulation using the "H" technique. Wien Klin Wochenschr 2023; 135:399-405. [PMID: 36472709 PMCID: PMC10444636 DOI: 10.1007/s00508-022-02115-x] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2022] [Accepted: 10/27/2022] [Indexed: 12/12/2022]
Abstract
BACKGROUND Sacral neuromodulation (SNM) is a widely accepted treatment for pelvic floor disorders, including constipation and fecal incontinence (FI). In 2017, a standardized electrode placement method, the H technique, was introduced to minimize failure rates and improve clinical outcomes. We aimed to investigate the technical feasibility and functional outcome of the procedure. METHODS In this prospective study, we evaluated the first 50 patients who underwent SNM according to the H technique between 2017 and 2020 at a tertiary care hospital. Patient demographic and clinical data were collected, and the impact of various factors on patients' postoperative quality of life (QoL) was assessed after a follow-up of 40 months. Functional outcome was monitored prospectively using a standardized questionnaire. RESULTS Of 50 patients, 36 (72%) reported greater than 50% symptom relief and received a permanent implant (95% CI: 58.3-82.5). We observed 75% success in relieving FI (95% CI: 58.9-86.3) and 64% in constipation (95% CI: 38.8-83.7). Complication occurred in five (10%) patients. Preoperative vs. postoperative physical and psychological QoL, Vaizey score, and obstructed defecation syndrome (ODS) scores revealed significant improvements (all p < 0.01). Male gender was significantly associated with postoperative complications (p = 0.035). CONCLUSION We provide evidence for the technical feasibility and efficacy of the SNM implantation using the H technique. The medium-term results are promising for patients with FI and constipation. Male patients and those with a BMI > 25 are more prone to perioperative complications.
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Affiliation(s)
- Mohammad Mahdi Kasiri
- Division of General Surgery, Department of Surgery, Medical University of Vienna/AKH, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Martina Mittlboeck
- Section for Clinical Biometrics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria
| | - Christopher Dawoud
- Division of General Surgery, Department of Surgery, Medical University of Vienna/AKH, Waehringer Guertel 18-20, 1090, Vienna, Austria
| | - Stefan Riss
- Division of General Surgery, Department of Surgery, Medical University of Vienna/AKH, Waehringer Guertel 18-20, 1090, Vienna, Austria.
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Pires M, Severo M, Lopes A, Neves S, Matzel K, Povo A. Sacral neuromodulation for low anterior resection syndrome: current status-a systematic review and meta-analysis. Int J Colorectal Dis 2023; 38:189. [PMID: 37428256 DOI: 10.1007/s00384-023-04485-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 06/30/2023] [Indexed: 07/11/2023]
Abstract
INTRODUCTION It is estimated that approximately 70% of patients with rectal cancer who undergo surgery will suffer from Low Anterior Resection Syndrome (LARS). In the last decades, sacral neuromodulation (SNM) has been widely used in urinary dysfunction and in faecal incontinence refractory to medical treatment. Its application in LARS has been investigated and has shown promising results. The paper's aim is to present a systematic review and meta-analysis of the available literature and evaluate the therapeutic success of SNM in patients with LARS. METHODS A systematic search was performed in international health-related databases: Cochrane Library, EMBASE, PubMed and SciELO. No restrictions on year of publication or language were applied. Retrieved articles were screened and selected according to set inclusion criteria. Data items were collected and processed for each included article and a meta-analysis was done according to the PRISMA guidelines. The primary outcome was the number of successful definitive SNM implants. Further outcomes included changes in bowel habits, incontinence scores, quality of life scores, anorectal manometry data and complications. RESULTS A total of 18 studies were included, with 164 patients being submitted to percutaneous nerve evaluation (PNE) with 91% responding successfully. During follow-up of therapeutic SNM some devices were explanted. The final clinical success rate was 77% after permanent implant. Other outcomes, such as the frequency of incontinent episodes, faecal incontinence scores, quality of life scores were overall improved after SNM. The meta-analysis showed a decrease in 10.11 incontinent episodes/week; a decrease of 9.86 points in the Wexner score and an increase in quality of life of 1.56 (pooled estimate). Changes in anorectal manometry were inconsistent. Local infection was the most common post-operative complication, followed by pain, mechanical issues, loss of efficacy and haematoma. DISCUSSION/CONCLUSION This is the largest systematic review and meta-analysis concerning the use of SNM in LARS patients. The findings support the available evidence that sacral neuromodulation can be effective in the treatment of LARS, with significant improvement in total incontinent episodes and patients´ quality of life.
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Affiliation(s)
- Marco Pires
- Serviço de Cirurgia Geral, Departamento de Cirurgia, Porto, CHUdSA, Portugal.
| | - Milton Severo
- ICBAS-UP-School of Medicine and Biomedical Sciences, Porto, Portugal
- Academic Clinical Center ICBAS-CHUdSA, Porto, Portugal
| | - Ana Lopes
- Serviço de Urologia, Departamento de Cirurgia, Porto, CHUdSA, Portugal
| | - Sílvia Neves
- ICBAS-UP-School of Medicine and Biomedical Sciences, Porto, Portugal
- Serviço de Cirurgia Geral de Ambulatório, Departamento de Cirurgia, Porto, CHUdSA, Portugal
| | - Klaus Matzel
- Section of Coloproctology, Department of Surgery, University of Erlangen, Erlangen, Germany
| | - Ana Povo
- ICBAS-UP-School of Medicine and Biomedical Sciences, Porto, Portugal
- Academic Clinical Center ICBAS-CHUdSA, Porto, Portugal
- Serviço de Cirurgia Geral de Ambulatório, Departamento de Cirurgia, Porto, CHUdSA, Portugal
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Bosch-Ramírez M, Sánchez-Guillén L, Alcaide-Quirós MJ, Aguilar-Martínez MM, Bellón-López M, López Delgado A, López-Rodríguez-Arias F, Muñoz-Duyos A, Barber-Valles X, Arroyo A. Long-term efficacy of percutaneous tibial nerve stimulation for faecal incontinence and a new approach for partial responders. Tech Coloproctol 2023; 27:443-451. [PMID: 36222850 PMCID: PMC10169891 DOI: 10.1007/s10151-022-02711-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/06/2022] [Accepted: 09/30/2022] [Indexed: 10/17/2022]
Abstract
BACKGROUND The aim of the present study was to evaluate the long-term efficacy of percutaneous tibial nerve stimulation (PTNS) for patients with faecal incontinence (FI) refractory to conservative treatment. Secondary aims were to identify predictors of response and validate new treatment pathways for partial responders. METHODS A prospective, interventional study was carried out in a specialist defecatory disorder unit from a university hospital between January 2010 and June 2017 on patients > 18 years old with FI refractory to conservative treatment. Thirty-minute PTNS sessions were performed in three phases (weekly, biweekly and monthly) up to a year, with clinical reassessment at 3, 6, 12 and 36 months. Patients were classified as optimal responders when their pretreatment Wexner score decreased > 50%; partial responders when it decreased 25-50%; and insufficient responders if it decreased < 25%. Only optimal and partial responders progressed into successive phases. RESULTS Between 2010 and 2017, 139 patients (110 women, median age 63 years [range 22-82 years]) were recruited. After the first phase, 4 patients were optimal responders, 93 were partial responders and 36 were insufficient responders. At 6 and 12 months, 66 and 89 patients respectively were optimal responders, with an optimal response rate of 64% at the end of treatment. A total of 93.3% patients with a partial response initially finally became optimal responders. Furthermore, at 36 months, 71.9% of patients were still optimal responders without supplementary treatment, although their quality of life did not improve significantly. Baseline Wexner scores ≤ 10 and symptom duration < 1 year were identified as predictive factors for positive responses to PTNS. CONCLUSIONS Patients undergoing PTNS for 1 year following this protocol had optimal long-term responses. PTNS sessions for up to 1 year in patients who were partial responders prevents a high percentage of them from needing more invasive treatments, and maintains long-term continence in patients who were optimal responders.
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Affiliation(s)
- M. Bosch-Ramírez
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
| | - L. Sánchez-Guillén
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
| | - M. J. Alcaide-Quirós
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
| | - M. M. Aguilar-Martínez
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
| | - M. Bellón-López
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
| | - A. López Delgado
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
| | - F. López-Rodríguez-Arias
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
| | - A. Muñoz-Duyos
- Department of General Surgery, Colorectal Unit, Mútua Terrassa University Hospital, University of Barcelona, Terrassa, Barcelona Spain
| | - X. Barber-Valles
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
- Center for Operations Research, University Miguel Hernández of Elche, Elche, Alicante Spain
- Joint Research Unit on Statistical Methods in Health Sciences UMH-FISABIO, University Miguel Hernández of Elche, Elche, Spain
| | - A. Arroyo
- Department of General Surgery, Colorectal Unit, Elche University Hospital, University Miguel Hernández of Elche, Camino de la Almazara 11, 03203 Elche, Alicante Spain
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12
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Bittorf B, Matzel K. [Sacral Neuromodulation for Fecal Incontinence and Constipation: Evidence, Programming and Long-term Management]. Zentralbl Chir 2023; 148:228-236. [PMID: 37267977 DOI: 10.1055/a-2063-3630] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/04/2023]
Abstract
BACKGROUND Over the last two decades, sacral neuromodulation (SNM) has established its role in the treatment of functional pelvic organ-/pelvic floor disorders. Even though the mode of action is not fully understood, SNM has become the preferred surgical treatment of fecal incontinence. METHODS AND RESULTS A literature search was carried out on programming sacral neuromodulation and long-term outcomes in treating fecal incontinence and constipation.Sacral neuromodulation was found to be successful in the long term. Over the years, the spectrum of indications has expanded, and now includes patients presenting with anal sphincter lesions. The use of SNM for low anterior resection syndrome (LARS) is currently under clinical investigation. Findings of SNM for constipation are less convincing. In several randomised crossover studies, no success was demonstrated, even though it is possible that subgroups may benefit from the treatment. Currently the application cannot be recommended in general.The pulse generator programming sets the electrode configuration, amplitude, pulse frequency and pulse width. Usually pulse frequency and pulse width follow a default setting (14 Hz, 210 s), while electrode configuration and stimulation amplitude are adjusted individually to the patient need and perception of stimulation.Despite low infection rates and few electrode-/pulse generator dysfunctions, up to 65% of patients require surgical reintervention during long term follow-up - in 50% of cases because of battery depletion, which is an expected event. At least one reprogramming is necessary in about 75% of the patients during the course of the treatment, mostly because of changes in effectiveness, but rarely because of pain. Regular follow-up visits appear to be advisable. CONCLUSION Sacral neuromodulation can be considered to be a safe and effective long-term therapy of fecal incontinence. To optimise the therapeutic effect, a structured follow-up regime is advisable.
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Affiliation(s)
- Birgit Bittorf
- Chirurgische Klinik, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland
| | - Klaus Matzel
- Chirurgische Klinik, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland
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Sensory brain activation during rectal balloon distention: a pilot study in healthy volunteers to assess safety and feasibility at 1.5T. MAGMA (NEW YORK, N.Y.) 2023; 36:25-32. [PMID: 36227394 PMCID: PMC9992048 DOI: 10.1007/s10334-022-01044-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/31/2022] [Revised: 09/15/2022] [Accepted: 10/03/2022] [Indexed: 03/08/2023]
Abstract
OBJECTIVE Although increasing evidence suggests a central mechanism of action for sacral neuromodulation, the exact mechanism remains unclear. We set up a scanning paradigm to measure brain activation related to various stages of rectal filling using rectal balloon distention. MATERIALS AND METHODS Six healthy volunteers underwent rectal balloon distention during MRI scanning at a 1.5T scanner with a Tx/Rx head coil. MR images were collected at four levels of distention: empty balloon (EB), first sensation volume (FSV), desire to defecate volume (DDV), maximum tolerable volume (MTV). Data were analyzed using BrainVoyager 20.4. Whole brain and ROI-based fixed-effects general linear model analyses were performed on the fMRI time-course data from all participants. RESULTS Rectal filling until FSV evoked the most blood-oxygen-level-dependent responses in several clusters throughout the cortex, followed by the responses evoked by rectal filling until DDV. Interestingly, rectal filling until MTV evoked negative responses compared to baseline throughout the cortex. No negative side effects were found. DISCUSSION This study shows that a standardized paradigm for functional MRI combined with rectal filling is feasible and safe in healthy volunteers and is ready to be used in fecal incontinent patients to assess whether their brain activity differs from healthy controls.
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Desprez C, Grange A, Gourcerol G, Deperrois A, Garçonnet O, Leroux C, Mosni G, Poux L, Breemeersch J, Goblot C, Kepka S, Ruillon J, Vannier M, Bridoux V, Leroi AM. Is sacral nerve modulation reprogramming effective after permanent implantation for faecal incontinence? Colorectal Dis 2022; 24:754-763. [PMID: 35133694 DOI: 10.1111/codi.16083] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/06/2021] [Revised: 12/12/2021] [Accepted: 12/28/2021] [Indexed: 02/08/2023]
Abstract
AIM Sacral nerve modulation (SNM) is recommended as a first-line surgical therapy for patients with faecal incontinence (FI). During patient follow-up, it is recommended that stimulation settings be reprogrammed to optimize patient outcomes. The aim of the present study was to evaluate the efficacy of stimulator reprogramming in patients with an implanted SNM device to treat FI. METHOD The data from patients who received a permanent SNM implant in a single centre from January 2008 to December 2019 were retrospectively analysed. Symptoms that occurred after implantation, the stimulator settings of the SNM device and changes made at each follow-up visit were noted. The efficacy of reprogramming was determined by assessing patient satisfaction. RESULTS Of the 117 patients (male/female 4/113; mean age 59.5 ± 11.8 years) with a SNM implant for FI, 84 (72%) had at least one symptom requiring reprogramming of the stimulator, most often during the first year after implantation (p = 0.05). The most frequently reported symptoms were loss of efficacy (68.5%; p = 1 × 10-3 ) and pain (20.5%; p = 1 × 10-3 ). Reprogramming was effective 53% of the time when treating loss of efficacy and 76% of the time when treating pain. When the stimulation parameters were reprogrammed at least four consecutive times to correct a symptom, the reprogramming was less effective in treating the symptom (p = 0.02). CONCLUSION Regular follow-up of patients with SNM device implants associated with reprogramming of stimulation parameters to improve the treatment of reported symptoms would optimize the efficacy of SNM.
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Affiliation(s)
| | | | - Guillaume Gourcerol
- Department of Digestive Physiology and CIC-CRB 1404, UNIROUEN, Inserm U1073, CHU Rouen, Normandie University, Rouen, France
| | | | | | | | | | | | | | | | | | | | - Margot Vannier
- Department of Biostatistics, Rouen University Hospital, Rouen, France
| | - Valérie Bridoux
- Department of Digestive Surgery, UNIROUEN, Inserm U1073, CHU Rouen, Normandie University, Rouen, France
| | - Anne-Marie Leroi
- Department of Digestive Physiology and CIC-CRB 1404, UNIROUEN, Inserm U1073, CHU Rouen, Normandie University, Rouen, France
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Colbran R, Gillespie C, Warwick A. A prospective trial of the THD SphinKeeper® for faecal incontinence. Colorectal Dis 2022; 24:491-496. [PMID: 34967085 DOI: 10.1111/codi.16037] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2021] [Revised: 10/10/2021] [Accepted: 10/22/2021] [Indexed: 02/08/2023]
Abstract
AIM THD SphinKeeper® is an emerging surgical technique for faecal incontinence (FI). The safety, indications and efficacy of the procedure are still being investigated. The aim of this study is to present the first experience of SphinKeeper® in Australia. METHOD This was a prospective single-centre observational study of patients undergoing SphinKeeper® implantation between February 2018 and September 2019. Baseline demographics, intraoperative and postoperative complications, Cleveland Clinic Faecal Incontinence Score, St Mark's Incontinence Score, Faecal Incontinence Quality of Life score (FIQOL), anorectal manometry and endo-anal ultrasound were assessed preoperatively and 3 and 12 months after implantation. RESULTS Thirteen patients (2 male, 11 female) underwent implantation during the study period. Anal sphincter defects were present in 13 (76.9%) patients [external anal sphincter (EAS) defect, 2 (15.4%); internal anal sphincter (IAS) defect 4 (30.8%); EAS + IAS defect, 4 (30.8%)]. Median follow-up was 32 months (range 18-37 months). There were four complications: one intraoperative (rectal perforation) and three postoperative (one implant extrusion, two implants that required removal due to malposition). At 12 months, an average of 9/10 implants remained ideally placed in each patient. THD SphinKeeper® insertion was associated with an improvement in coping/behaviour as measured using FIQOL (p = 0.047). However, the procedure did not improve FI scores or anorectal manometry parameters. CONCLUSION In this study, SphinKeeper® marginally improved symptoms of FI but there was no significant impact on anorectal manometric measurements. Larger-scale studies are needed to determine the patient cohort most likely to benefit from this procedure.
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Affiliation(s)
- Rachel Colbran
- Queen Elizabeth II Jubilee Hospital, Coopers Plains, Qld, Australia.,Faculty of Medicine, University of Queensland, St Lucia, Qld, Australia.,Brisbane Academic Functional Colorectal Unit, Brisbane, Qld, Australia
| | - Christopher Gillespie
- Queen Elizabeth II Jubilee Hospital, Coopers Plains, Qld, Australia.,Faculty of Medicine, University of Queensland, St Lucia, Qld, Australia.,Brisbane Academic Functional Colorectal Unit, Brisbane, Qld, Australia
| | - Andrea Warwick
- Queen Elizabeth II Jubilee Hospital, Coopers Plains, Qld, Australia.,Faculty of Medicine, University of Queensland, St Lucia, Qld, Australia.,Brisbane Academic Functional Colorectal Unit, Brisbane, Qld, Australia
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16
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Zyczynski HM, Richter HE, Sung VW, Lukacz ES, Arya LA, Rahn DD, Visco AG, Mazloomdoost D, Carper B, Gantz MG, NICHD Pelvic Floor Disorders Network. Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial. Am J Gastroenterol 2022; 117:654-667. [PMID: 35354778 PMCID: PMC8988447 DOI: 10.14309/ajg.0000000000001605] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/01/2021] [Accepted: 11/19/2021] [Indexed: 12/11/2022]
Abstract
INTRODUCTION To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. METHODS Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. RESULTS Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. DISCUSSION Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.
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Affiliation(s)
- Halina M. Zyczynski
- Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/ Magee-Womens Research Institute, Pittsburgh, PA
| | - Holly E. Richter
- Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL
| | - Vivian W. Sung
- Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women’s & Infants Hospital, Providence, RI
| | - Emily S. Lukacz
- Department of Obstetrics, Gynecology & Reproductive Sciences, UC San Diego Health, San Diego, CA
| | - Lily A. Arya
- Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, PA
| | - David D. Rahn
- Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX
| | - Anthony G. Visco
- Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC
| | - Donna Mazloomdoost
- Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States
| | - Benjamin Carper
- Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC, United States
| | - Marie G. Gantz
- Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC, United States
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Tibial Nerve Stimulation for Fecal Incontinence: The Importance of Sham. Am J Gastroenterol 2022; 117:605-606. [PMID: 35130191 DOI: 10.14309/ajg.0000000000001676] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2021] [Accepted: 02/01/2022] [Indexed: 12/11/2022]
Abstract
Sacral neuromodulation has become an established treatment for fecal incontinence unresponsive to conservative measures. However, it requires surgical implantation and is expensive. Percutaneous tibial nerve stimulation (PTNS) has been suggested as a minimally invasive and less expensive alternative on the basis of uncontrolled studies. The study by Zyczynski et al. compared active PTNS with a sham control group of women with fecal incontinence. Similar to previous studies, active PTNS provided benefits to treated patients but were not different from the sham group. This study highlights the need for rigorously performed controlled studies of neuromodulation for anorectal disorders.
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Shimazutsu K, Watadani Y, Ohge H. Efficacy and Safety of the Japanese Herbal Medicine Daikenchuto (DKT) in Elderly Fecal Incontinence Patients: A Prospective Study. J Anus Rectum Colon 2022; 6:32-39. [PMID: 35128135 PMCID: PMC8801247 DOI: 10.23922/jarc.2021-038] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2021] [Accepted: 08/19/2021] [Indexed: 11/30/2022] Open
Abstract
Objectives: Methods: Results: Conclusions:
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Affiliation(s)
| | - Yusuke Watadani
- Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
| | - Hiroki Ohge
- Department of Infectious Diseases, Hiroshima University Hospital
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Critical appraisal of international guidelines for the management of fecal incontinence in adults: is it possible to define what to do in different clinical scenarios? Tech Coloproctol 2021; 26:1-17. [PMID: 34767095 PMCID: PMC8587500 DOI: 10.1007/s10151-021-02544-2] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/21/2020] [Accepted: 10/28/2021] [Indexed: 11/10/2022]
Abstract
Fecal incontinence (FI) is a complex often multifactorial functional disorder which is associated with a significant impact on patients’ quality of life. There is a broad spectrum of symptoms, and degrees of severity and diverse patient backgrounds. Several treatment algorithms from different professional societies and experts are available in the literature. However, no consensus has been reached on several aspects of FI management. We performed a critical review of the most recently published guidelines on FI, emphasising the lack of consensus, highlighting specific topics mentioned in each of the guidelines that are not covered in the others and defining the treatment proposed in different clinical scenarios.
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20
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Lehur PA. A search for new options to manage fecal incontinence. Tech Coloproctol 2021; 25:1323-1325. [PMID: 34643828 DOI: 10.1007/s10151-021-02535-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2021] [Accepted: 09/30/2021] [Indexed: 10/20/2022]
Abstract
Fecal incontinence (FI) is a highly prevalent condition known to substantially impair a patient's quality of life. Although a non-invasive treatment option, currently available anal plugs are poorly tolerated, not significantly effective and therefore not often used. We present a new disposable device based on an innovative concept that renews the interest for non-invasive "external" control of bowel content for FI patients. The Contix™ (Forconti Medical Ltd, Cesarea, Israel) permits creation of temporary "artificial" fecal impaction to avoid bowel leakage while inserted high into the "non sensitive" rectum where it is not felt by the patient and therefore tolerated for 6- to 12- hour use. This European conformity (CE)-marked device has a unique design that allows insertion, usage and removal in a similar manner to a vaginal pad. It comes in 2 parts: a flexible silicone-based oval-shaped biocompatible balloon and an applicator in which the balloon is folded for self-insertion. An external tube allows for the balloon to be inflated with 60-100ml. of air. In doing this, small smooth tines deploy on its surface to help maintain the balloon in place. A pulling string with a ring stays out of the anal canal to deflate and withdraw the balloon inverted on itself at end of use. Device handling that includes rectal insertion and withdrawal feasibility, wear time, comfort at the different steps of use, safety and of course effectiveness of Contix™ have been tested in small trials yet to be published but pilot studies support its uses at greater scale in expert centers in Europe and the United States. In summary the Contix™ is a non-invasive device for FI management based on an innovative concept. Initial results support its spread to identify its role as an ancillary service to existing approaches.
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Affiliation(s)
- P-A Lehur
- Coloproctology Unit, Ospedale Regionale di Lugano, Lugano, Switzerland. .,, Nantes, France.
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21
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ACG Clinical Guidelines: Management of Benign Anorectal Disorders. Am J Gastroenterol 2021; 116:1987-2008. [PMID: 34618700 DOI: 10.14309/ajg.0000000000001507] [Citation(s) in RCA: 62] [Impact Index Per Article: 15.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/05/2020] [Accepted: 08/09/2021] [Indexed: 12/11/2022]
Abstract
Benign anorectal disorders of structure and function are common in clinical practice. These guidelines summarize the preferred approach to the evaluation and management of defecation disorders, proctalgia syndromes, hemorrhoids, anal fissures, and fecal incontinence in adults and represent the official practice recommendations of the American College of Gastroenterology. The scientific evidence for these guidelines was assessed using the Grading of Recommendations Assessment, Development and Evaluation process. When the evidence was not appropriate for Grading of Recommendations Assessment, Development and Evaluation, we used expert consensus to develop key concept statements. These guidelines should be considered as preferred but are not the only approaches to these conditions.
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22
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Meyer I, Richter HE. Accidental Bowel Leakage/Fecal Incontinence: Evidence-Based Management. Obstet Gynecol Clin North Am 2021; 48:467-485. [PMID: 34416932 DOI: 10.1016/j.ogc.2021.05.003] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
Fecal incontinence is a highly prevalent and debilitating condition that negatively impacts quality of life. The etiology is often multifactorial and treatment can be hindered by lack of understanding of its mechanisms and available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.
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Affiliation(s)
- Isuzu Meyer
- Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233, USA.
| | - Holly E Richter
- Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233, USA
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Abstract
Sacral neuromodulation (SNM) has been available in the United States for more than 20 years and is a guideline-recommended therapy by both the American Urological Association and the American Society of Colon and Rectal Surgeons, with proven long-term success for urinary urgency incontinence, urinary urgency frequency, nonobstructive urinary retention, and fecal incontinence. Initially the therapy involved a more invasive surgical approach that included a large cut down over the sacrum. This article reviews recent advancements in SNM therapy including updates in best practices for implant technique, technological innovations, and the new clinical literature relevant to contemporary practice.
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Couvaras A, Goudelocke C. Optimizing Lead Placement in Sacral Neuromodulation. CURRENT BLADDER DYSFUNCTION REPORTS 2021. [DOI: 10.1007/s11884-021-00634-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/24/2022]
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Meurette G, Siproudhis L, Leroi AM, Damon H, Urs Josef Keller D, Faucheron JL. Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study. Colorectal Dis 2021; 23:1463-1473. [PMID: 33387373 DOI: 10.1111/codi.15507] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2020] [Revised: 11/06/2020] [Accepted: 11/23/2020] [Indexed: 12/26/2022]
Abstract
AIM The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStimTM system for the treatment of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable. METHOD This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow-up visits within 1 and 15 months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events. RESULTS A total of 221 subjects with a mean age of 62.1 years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow-up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1-3, 4-8 and 9-15 months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p < 0.0001). Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device-related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports. CONCLUSION This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real-life.
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Affiliation(s)
| | | | | | - Henri Damon
- Hôpital Edouard Herriot, CHU de Lyon, Lyon, France
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Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Female Pelvic Med Reconstr Surg 2021; 27:726-734. [PMID: 33950027 DOI: 10.1097/spv.0000000000001050] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
OBJECTIVES High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage. METHODS The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. RESULTS Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. CONCLUSIONS The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.
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Katuwal B, Bhullar J. Current Position of Sacral Neuromodulation in Treatment of Fecal Incontinence. Clin Colon Rectal Surg 2021; 34:22-27. [PMID: 33536846 PMCID: PMC7843948 DOI: 10.1055/s-0040-1714247] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Abstract
Fecal incontinence (FI) is defined as uncontrolled passage of feces or gas for at least 1-month duration in an individual who previously had control. FI is a common and debilitating condition affecting many individuals. Continence depends on complex relationships between anal sphincters, rectal curvatures, rectoanal sensation, rectal compliance, stool consistency, and neurologic function. Factors, such as pregnancy, chronic diarrhea, diabetes mellitus, previous anorectal surgery, urinary incontinence, smoking, obesity, limited physical activity, white race, and neurologic disease, are known to be the risk factors for FI. Conservative/medical management including biofeedback are recognized as the first-line treatment of the FI. Those who are suitable for surgical intervention and who have failed conservative management, sacral nerve stimulation (SNS) has emerged as the treatment of choice in many patients. The surgical technique involves placement of a tined lead with four electrodes through the S3 sacral foramen. The lead is attached to a battery, which acts as a pulse generator, and is placed under the patient's skin in the lower lumbar region. The use of SNS in the treatment of FI has increased over the years and the beneficial effects of this treatment have been substantiated by multiple studies. This review describes SNS as a modality of treatment for FI and its position in the current medical diaspora in patients with FI.
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Affiliation(s)
- Binit Katuwal
- Department of Surgery, Providence Hospital & Medical Centers, Southfield, Michigan
| | - Jasneet Bhullar
- Department of Surgery, UPMC Williamsport, Williamsport, Pennsylvania
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Leo CA, Thomas GP, Bradshaw E, Karki S, Hodgkinson JD, Murphy J, Vaizey CJ. Long-term outcome of sacral nerve stimulation for faecal incontinence. Colorectal Dis 2020; 22:2191-2198. [PMID: 32954658 DOI: 10.1111/codi.15369] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2020] [Accepted: 09/06/2020] [Indexed: 12/11/2022]
Abstract
AIM Sacral nerve stimulation (SNS) is a minimally invasive treatment for faecal incontinence (FI). We report our experience of patients who have undergone SNS for FI with a minimum of 5 years' follow-up. This is a single centre prospective observational study with the aim to assess the long-term function of SNS. METHOD All patients implanted with SNS were identified from our prospective database. The date of implantation, first and last clinic follow-up, surgical complications and St Mark's incontinence scores were abstracted and analysed. RESULTS From 1996 to 2014, 381 patients were considered for SNS. Of these, 256 patients met the study inclusion criteria. Median age at implantation was 52 years (range 18-81). The ratio of women to men was 205:51. Indications were urge FI (25%), passive FI (17.9%) and mixed FI (57%). The median of the incontinence score at baseline was 19/24 and this improved to 7/24 at the 6-month follow-up. Of the total cohort, 235 patients received a medium-term follow-up (median 110 months, range 12-270) with a median continence score of 10/24 which was also confirmed at the telephone long-term follow-up on 185 patients (132 months, range 60-276). CONCLUSION This study demonstrates that SNS is an effective treatment in the long term. SNS results in an improvement of validated scores for approximately 60% of patients; however, there is a significant reduction of efficacy over time due to underlying causes.
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Affiliation(s)
- C A Leo
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK.,Imperial College London, London, UK.,Northwick Park Hospital, London North West NHS Trust, Harrow, UK
| | - G P Thomas
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK
| | - E Bradshaw
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK
| | - S Karki
- Northwick Park Hospital, London North West NHS Trust, Harrow, UK
| | - J D Hodgkinson
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK.,Imperial College London, London, UK
| | - J Murphy
- Imperial College London, London, UK
| | - C J Vaizey
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK.,Imperial College London, London, UK
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D’Amico F, Wexner SD, Vaizey CJ, Gouynou C, Danese S, Peyrin-Biroulet L. Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review. United European Gastroenterol J 2020; 8:886-922. [PMID: 32677555 PMCID: PMC7707876 DOI: 10.1177/2050640620943699] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/24/2020] [Accepted: 06/09/2020] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Fecal incontinence is a disabling condition affecting up to 20% of women. OBJECTIVE We investigated fecal incontinence assessment in both inflammatory bowel disease and non-inflammatory bowel disease patients to propose a diagnostic approach for inflammatory bowel disease trials. METHODS We searched on Pubmed, Embase and Cochrane Library for all studies on adult inflammatory bowel disease and non-inflammatory bowel disease patients reporting data on fecal incontinence assessment from January 2009 to December 2019. RESULTS In total, 328 studies were included; 306 studies enrolled non-inflammatory bowel disease patients and 22 studies enrolled inflammatory bowel disease patients. In non-inflammatory bowel disease trials the most used tools were the Wexner score, fecal incontinence quality of life questionnaire, Vaizey score and fecal incontinence severity index (in 187, 91, 62 and 33 studies). Anal manometry was adopted in 41.2% and endoanal ultrasonography in 34.0% of the studies. In 142 studies (46.4%) fecal incontinence evaluation was performed with a single instrument, while in 64 (20.9%) and 100 (32.7%) studies two or more instruments were used. In inflammatory bowel disease studies the Wexner score, Vaizey score and inflammatory bowel disease quality of life questionnaire were the most commonly adopted tools (in five (22.7%), five (22.7%) and four (18.2%) studies). Anal manometry and endoanal ultrasonography were performed in 45.4% and 18.2% of the studies. CONCLUSION Based on prior validation and experience, we propose to use the Wexner score as the first step for fecal incontinence assessment in inflammatory bowel disease trials. Anal manometry and/or endoanal ultrasonography should be taken into account in the case of positive questionnaires.
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Affiliation(s)
- Ferdinando D’Amico
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France
| | - Steven D Wexner
- Department of Colorectal Surgery, Cleveland Clinic Florida, Weston USA
| | | | - Célia Gouynou
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France
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Abstract
Nine percent of adult women experience episodes of fecal incontinence at least monthly. Fecal incontinence is more common in older women and those with chronic bowel disturbance, diabetes, obesity, prior anal sphincter injury, or urinary incontinence. Fecal incontinence negatively affects quality of life and mental health and is associated with increased risk of nursing home placement. Fewer than 30% of women with fecal incontinence seek care, and lack of information about effective solutions is an important barrier for both patients and health care professionals. Even among women with both urinary and fecal incontinence presenting for urogynecologic care, the rate of verbal disclosure of fecal incontinence symptoms remains low. This article provides an overview of the evaluation and management of fecal incontinence for the busy obstetrician-gynecologist, incorporating existing guidance from the American College of Obstetricians and Gynecologists, the American College of Gastroenterology, and the American Society of Colon and Rectal Surgeons. The initial clinical evaluation of fecal incontinence requires a focused history and physical examination. Recording patient symptoms using a standard diary or questionnaire can help document symptoms and response to treatment. Invasive diagnostic testing and imaging generally are not needed to initiate treatment but may be considered in complex cases. Most women have mild symptoms that will improve with optimized stool consistency and medications. Additional treatment options include pelvic floor muscle strengthening with or without biofeedback, devices placed anally or vaginally, and surgery, including sacral neurostimulation, anal sphincteroplasty, and, for severely affected individuals for whom other interventions fail, colonic diversion.
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Affiliation(s)
- Heidi W Brown
- University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin; Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, California; and the Department of Women's Health, Dell Medical School, University of Texas at Austin, Austin Texas
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De Meyere C, Nuytens F, Parmentier I, D'Hondt M. Five-year single center experience of sacral neuromodulation for isolated fecal incontinence or fecal incontinence combined with low anterior resection syndrome. Tech Coloproctol 2020; 24:947-958. [PMID: 32556866 DOI: 10.1007/s10151-020-02245-2] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/13/2019] [Accepted: 05/15/2020] [Indexed: 02/06/2023]
Abstract
PURPOSE Sacral neuromodulation (SNM) has proven to be a safe and effective treatment for fecal incontinence (FI). For low anterior resection syndrome (LARS), however, SNM efficacy is still poorly documented. The primary aim of this study was to report on efficacy of SNM therapy for patients with isolated FI or LARS. Furthermore, we evaluated the safety of the procedure and the relevance of adequate follow-up. METHODS A retrospective analysis was performed upon a prospectively maintained database of all patients who underwent SNM therapy for isolated FI or LARS between January 2014 and January 2019. The Wexner and LARS scores were evaluated at baseline, during test phase, after definitive implantation and annually during follow-up. Treatment success was defined as at least 50% improvement of the Wexner score or a reduction to minor or no LARS. RESULTS Out of 89 patients with isolated FI or LARS who had a SNM test phase, 62 patients were eligible for implantation of the permanent SNM device. At baseline, 3 weeks, and 1, 2, 3, 4 and 5 years after definitive implantation the median Wexner score of all patients was 18, 2, 4.5, 5, 5, 4 and 4.5, respectively, and 18, 4, 5.5, 5, 4, 3 and 4, respectively, for patients with FI and LARS. Patients with LARS more frequently required changes in program settings. CONCLUSIONS SNM therapy is a safe and effective treatment for patients with isolated FI and patients with FI and LARS. Adequate follow-up is essential to ensure long-term effectivity, especially for LARS patients.
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Affiliation(s)
- C De Meyere
- Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium
| | - F Nuytens
- Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium
| | - I Parmentier
- Department of Oncology and Statistics, Groeninge Hospital, Kortrijk, Belgium
| | - M D'Hondt
- Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.
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Hidaka J, Lundby L, Laurberg S, Duelund-Jakobsen J. Comparison of long-term outcome of sacral nerve stimulation for constipation and faecal incontinence with focus on explantation rate, additional visits, and patient satisfaction. Tech Coloproctol 2020; 24:1189-1195. [PMID: 32856184 DOI: 10.1007/s10151-020-02328-0] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2020] [Accepted: 08/01/2020] [Indexed: 01/15/2023]
Abstract
BACKGROUND The aim of the present study was to compare sacral nerve stimulation (SNS) for constipation (SNS-C) with SNS for idiopathic faecal incontinence (SNS-IFI) regarding explantation rate, additional visits, and improvement of patient satisfaction 5 years after implantation. METHODS From our prospective database (launched in 2009), we extracted all SNS-C patients 5 years post-implantation, and the SNS-IFI patients implanted just before and just after each SNS-C patient. We retrospectively evaluated the explantation rate, number of additional visits, and patient satisfaction using a visual analogue scale (VAS). We hypothesized that compared with those in the SNS-IFI group: (1) the explantation rate would be higher in SNS-C patients, (2) the number of additional visits would be higher in SNS-C patients, and (3) in patients with an active implant at 5 years, the improvement in VAS would be the same. RESULTS We included 40 SNS-C patients and 80 SNS-IFI patients. In the SNS-C group 7/40 (17.5%), patients were explanted, compared to 10/80 (12.5%) patients in the SNS-IFI group (p = 0.56). The mean number of additional visits in the SNS-C group was 3.5 (95% CI 2.8-4.1)) and 3.0 (95% CI 2.6-3.6)) in the SNS-IFI group (p = 0.38). Additional visits due to loss of efficacy were significantly higher in the SNS-C patients (p = 0.03). The reduction in VAS score (delta VAS) at 5 years was 37.1 (95% CI 20.9-53.3) in the SNS-C group, and 46.0 (95% CI 37.9-54.0) in the SNS-IFI group (p = 0.27). CONCLUSIONS No significant difference was found regarding explantation rate, number of additional visits, or improvement of VAS at 5 years after SNS implantation between SNS-C patients and SNS-IFI patients.
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Affiliation(s)
- J Hidaka
- Department of Surgery, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus N, Denmark. .,Hidaka Coloproctology Clinic, Kurume, Japan.
| | - L Lundby
- Department of Surgery, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus N, Denmark
| | - S Laurberg
- Department of Surgery, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus N, Denmark
| | - J Duelund-Jakobsen
- Department of Surgery, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus N, Denmark
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Stanton AP, Chen AH. New options for managing fecal incontinence in women. JAAPA 2020; 33:50-52. [PMID: 32740116 DOI: 10.1097/01.jaa.0000684168.68881.61] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
Fecal incontinence often is underreported and can be associated with both social embarrassment and isolation. As patients often do not proactively discuss their symptoms, healthcare providers should screen for this distressing condition. The cause of fecal incontinence often is multifactorial, so no single therapy can guarantee perfect, risk-free outcomes. This article reviews the limited therapies for managing fecal incontinence, including a minimally invasive vaginal control device that may offer hope for managing fecal incontinence in women.
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Affiliation(s)
- Amanda P Stanton
- Amanda P. Stanton practices in the Department of Medical and Surgical Gynecology at Mayo Clinic in Jacksonville, Fla., and is an instructor of obstetrics and gynecology at Mayo Clinic College of Medicine and Science. Anita H. Chen is a consultant at Mayo Clinic in Florida and an assistant professor of obstetrics and gynecology at Mayo Clinic College of Medicine and Science. The authors have disclosed no potential conflicts of interest, financial or otherwise
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Ram E, Meyer R, Carter D, Gutman M, Rosin D, Horesh N. The efficacy of sacral neuromodulation in the treatment of low anterior resection syndrome: a systematic review and meta-analysis. Tech Coloproctol 2020; 24:803-815. [PMID: 32350733 DOI: 10.1007/s10151-020-02231-8] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2019] [Accepted: 04/22/2020] [Indexed: 12/17/2022]
Abstract
BACKGROUND Sacral neuromodulation (SNM) has become one of the main treatment options in patients with fecal incontinence. The aim of this study was to determine the efficacy of sacral neuromodulation in the treatment of low anterior resection syndrome (LARS). METHODS A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The search was conducted using the Pubmed, Embase, Ovid, and Cochrane databases, restricted to the English language and to articles published from 2000 to November 2018. RESULTS A total of 434 articles on the efficacy of SNM in the treatment of LARS were retrieved, and 13 studies were included in the final analysis, with a total of 114 patients treated with SNM for LARS The overall success rate excluding study heterogeneity was 83.30% [95% CI (71.33-95.25%)]. Improvement in anal continence was seen in several clinical and functional parameters, including the Wexner Score [10.78 points, 95% CI (8.55-13.02), p < 0.0001], manometric maximum resting pressure [mean improvement of 6.37 mm/Hg, 95% CI (2.67-10.07), p = 0.0007], maximum squeeze pressure [mean improvement of 17.99 mm/Hg, 95% CI (17.42-18.56), p < 0.0001] and maximum tolerated volume [mean improvement of 22.74 ml, 95% CI (10.65-34.83), p = 0.0002]. Quality of life questionnaires also demonstrated significant improvement in patients' quality of life, but were reported only in a small group of included patients. CONCLUSIONS SNM significantly improves symptoms and quality of life in patients suffering from fecal incontinence following low anterior resection.
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Affiliation(s)
- E Ram
- Department of Surgery B, Sheba Medical Centre, Tel Hashomer, Israel.
- Tel Aviv University, Tel Aviv, Israel.
| | - R Meyer
- Tel Aviv University, Tel Aviv, Israel
- Department of Gynecology and Obstetrics, Sheba Medical Centre, Tel Hashomer, Israel
| | - D Carter
- Tel Aviv University, Tel Aviv, Israel
- Department of Gastroenterology, Sheba Medical Centre, Tel Hashomer, Israel
| | - M Gutman
- Department of Surgery B, Sheba Medical Centre, Tel Hashomer, Israel
- Tel Aviv University, Tel Aviv, Israel
| | - D Rosin
- Department of Surgery B, Sheba Medical Centre, Tel Hashomer, Israel
- Tel Aviv University, Tel Aviv, Israel
| | - N Horesh
- Department of Surgery B, Sheba Medical Centre, Tel Hashomer, Israel
- Tel Aviv University, Tel Aviv, Israel
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Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study. Ann Surg 2020; 275:735-742. [PMID: 32740249 DOI: 10.1097/sla.0000000000004251] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA Few studies have evaluated the long-term success of SNM. METHODS Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.
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Brinas P, Zalay N, Philis A, Castel-Lacanal E, Barrieu M, Portier G. Use of Malone antegrade continence enemas in neurologic bowel dysfunction. J Visc Surg 2020; 157:453-459. [PMID: 32247623 DOI: 10.1016/j.jviscsurg.2020.03.007] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
INTRODUCTION Patients with neurogenic bowel dysfunction (NBD) suffer severe constipation and/or fecal incontinence that are very difficult to treat. Most medication-based and interventional treatments have been unsuccessful. The goal of this study was to assess the medium-term effectiveness of the Malone procedure in all patients with NBD, as an alternative to colostomy. PATIENTS AND METHODS In this retrospective single-center study, 23 patients who underwent Malone's surgical treatment were analyzed. The main criteria were the usage of antegrade colonic enemas (ACE) after Malone's procedure at the most recent follow-up and comparison of quality of life scores before and after surgery. RESULTS The post-procedure mortality was zero, but an overall morbidity of 60% was observed, including minor complications (Clavien 1, 2) in 56%. The median follow-up was 33 months. At the most recent follow-up, the utilization rate of the neo-appendicostomy for ACE was 69.6%; 76.9% of the patients using ACE reported improvement in quality of life scores. Secondary colostomy was performed in 21.7% for functional failure of the Malone procedure. CONCLUSION The Malone procedure is a reliable technique that can be used in the therapeutic strategy for managing NBD patients with incontinence/constipation refractory to usual treatments. It should be considered as a therapeutic step to take before resorting to colostomy.
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Affiliation(s)
- P Brinas
- University Hospital of Toulouse, 1, avenue Jean-Poulhes, 31059 Toulouse, France
| | - N Zalay
- University Hospital of Toulouse, 1, avenue Jean-Poulhes, 31059 Toulouse, France
| | - A Philis
- University Hospital of Toulouse, 1, avenue Jean-Poulhes, 31059 Toulouse, France
| | - E Castel-Lacanal
- University Hospital of Toulouse, 1, avenue Jean-Poulhes, 31059 Toulouse, France
| | - M Barrieu
- University Hospital of Toulouse, 1, avenue Jean-Poulhes, 31059 Toulouse, France
| | - G Portier
- University Hospital of Toulouse, 1, avenue Jean-Poulhes, 31059 Toulouse, France.
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37
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Southwell BR. Electro‐Neuromodulation for Colonic Disorders—Review of Meta‐Analyses, Systematic Reviews, and RCTs. Neuromodulation 2020; 23:1061-1081. [DOI: 10.1111/ner.13099] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2019] [Revised: 10/30/2019] [Accepted: 12/11/2019] [Indexed: 02/06/2023]
Affiliation(s)
- Bridget R. Southwell
- Surgical Research Group Murdoch Children's Research Institute Melbourne Australia
- Department of Urology Royal Children's Hospital Melbourne Australia
- Department of Paediatrics University of Melbourne Melbourne Australia
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Varghese C, Wells CI, O'Grady G, Bissett IP. Costs and outcomes of sacral nerve stimulation for faecal incontinence in New Zealand: a 10‐year observational study. ANZ J Surg 2020; 90:569-575. [DOI: 10.1111/ans.15656] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2019] [Revised: 12/13/2019] [Accepted: 12/17/2019] [Indexed: 12/13/2022]
Affiliation(s)
- Chris Varghese
- Department of Surgery, Faculty of Medical and Health SciencesThe University of Auckland Auckland New Zealand
| | - Cameron I. Wells
- Department of Surgery, Faculty of Medical and Health SciencesThe University of Auckland Auckland New Zealand
- Department of SurgeryAuckland District Health Board Auckland New Zealand
| | - Gregory O'Grady
- Department of Surgery, Faculty of Medical and Health SciencesThe University of Auckland Auckland New Zealand
- Department of SurgeryAuckland District Health Board Auckland New Zealand
- Auckland Bioengineering InstituteThe University of Auckland Auckland New Zealand
| | - Ian P. Bissett
- Department of Surgery, Faculty of Medical and Health SciencesThe University of Auckland Auckland New Zealand
- Department of SurgeryAuckland District Health Board Auckland New Zealand
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Kosteneffektivität der Nervenstimulationsmethoden bei Stuhlinkontinenz. COLOPROCTOLOGY 2019. [DOI: 10.1007/s00053-019-00409-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
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Abstract
Fecal incontinence (FI) is the uncontrolled passage of feces or gas in an individual who previously had control. The prevalence of the problem varies but can be as high as 50% of institutionalized individuals. The severity varies among individuals, but the negative impact on self-esteem and quality of life can have devastating effects. The goals of treatment are to decrease the frequency and severity of episodes as well as to improve quality of life. At present, several therapies, ranging from medical management to more invasive surgical interventions, are offered for the management of FI. In this article, we review the most recent advances in the management of FI.
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Affiliation(s)
- Giovanna Da Silva
- Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL, 33331, USA
| | - Anne Sirany
- Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL, 33331, USA
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Mege D, Meurette G, Brochard C, Damon H, Lambrescak E, Faucheron JL, Wyart V, Lehur PA, Sielezneff I, Siproudhis L, Mion F, Etienney I, Houivet E, Bridoux V, Leroi AM. Sacral nerve modulation for faecal incontinence: influence of age on outcomes and complications. A multicentre study. Colorectal Dis 2019; 21:1058-1066. [PMID: 30985984 DOI: 10.1111/codi.14649] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2019] [Accepted: 04/02/2019] [Indexed: 02/08/2023]
Abstract
AIM Faecal incontinence is frequent in the elderly. Little is currently known about the efficacy of sacral nerve modulation (SNM) in the elderly. The present study aimed to assess the impact of age on the outcome of SNM and on the surgical revision and explantation rates by comparing the results of a large data set of patients. METHOD Prospectively collected data from patients who underwent an implant procedure between January 2010 and December 2015 in seven French centres were retrospectively evaluated. In total, 352 patients [321 women; median age (range): 63 (24-86) years] were included. Clinically favourable and unfavourable outcomes, and surgical revision and explantation rates, were compared according to the age of the patients. RESULTS A similar outcome was observed when comparing patients < 70 years and ≥ 70 years (a favourable outcome in 79.2% and 76.2%, respectively, P = 0.89). The probability of a successful treatment as a function of time was similar for the two age groups (< 70 years and ≥ 70 years, P = 0.54). The explantation and revision rates were not influenced by age (explantation rate: 17% in patients < 70 years vs 14% in patients ≥ 70 years, P = 0.89; and revision rate: 42% in patients < 70 years vs 40% in patients ≥ 70 years, P = 0.89). The probability of explantation as a function of time was similar for the two age groups (P = 0.82). The limitations of this study were its retrospective status, the rate of loss at follow-up and different durations of patient follow-up. CONCLUSIONS Our results suggest that patients ≥ 70 years suffering from faecal incontinence benefit from SNM with a similar risk as a younger population.
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Affiliation(s)
- D Mege
- Department of Digestive Surgery, Assistance Publique Hôpitaux de Marseille, Timone University Hospital, Marseille, France
| | - G Meurette
- Digestive and Endocrine Surgery Clinic, Diseases of the Digestive Tract Institute, University Hospital of Nantes, Nantes, France
| | - C Brochard
- Diseases of the Digestive Tract Department, Functional Digestive Explorations Division, CHU Pontchaillou, CIC1414, INPHY, INSERM U1241, Université de Rennes 1, Rennes, France
| | - H Damon
- Digestive Physiology, University Hospital of Lyon, Hospices Civils de Lyon, Hôpital E Herriot, Lyon, France
| | - E Lambrescak
- Department of Coloproctology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France
| | - J-L Faucheron
- Department of Surgery, Colorectal Unit, Michallon University Hospital, Grenoble, France.,University Grenoble Alps, UMR 5525, CNRS, TIMC-IMAG, Grenoble, France
| | - V Wyart
- Digestive and Endocrine Surgery Clinic, Diseases of the Digestive Tract Institute, University Hospital of Nantes, Nantes, France
| | - P-A Lehur
- Digestive and Endocrine Surgery Clinic, Diseases of the Digestive Tract Institute, University Hospital of Nantes, Nantes, France.,Department of General Surgery, Ospedale Civico di Lugano, Lugano, Switzerland
| | - I Sielezneff
- Department of Digestive Surgery, Assistance Publique Hôpitaux de Marseille, Timone University Hospital, Marseille, France
| | - L Siproudhis
- Diseases of the Digestive Tract Department, Functional Digestive Explorations Division, CHU Pontchaillou, CIC1414, INPHY, INSERM U1241, Université de Rennes 1, Rennes, France
| | - F Mion
- Digestive Physiology, University Hospital of Lyon, Hospices Civils de Lyon, Hôpital E Herriot, Lyon, France
| | - I Etienney
- Department of Coloproctology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France
| | - E Houivet
- Biostatistics Unit, INSERM CIC 1404, Rouen, France
| | - V Bridoux
- Department of Digestive Surgery, Normandie Univ, UNIROUEN Inserm U1073, Rouen University Hospital, Rouen, France
| | - A-M Leroi
- Department of Digestive Physiology and CIC-CRB 1404, Normandie Univ, UNIROUEN, Inserm U1073, Rouen University Hospital, Rouen, France
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Brochard C, Mege D, Bridoux V, Meurette G, Damon H, Lambrescak E, Faucheron JL, Trilling B, Lehur PA, Wyart V, Sielezneff I, Mion F, Etienney I, Leroi AM, Siproudhis L. Is Sacral Nerve Modulation a Good Option for Fecal Incontinence in Men? Neuromodulation 2019; 22:745-750. [PMID: 31318471 DOI: 10.1111/ner.13017] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/15/2019] [Revised: 05/09/2019] [Accepted: 05/15/2019] [Indexed: 12/20/2022]
Abstract
OBJECTIVE The objective was to assess the efficacy and the safety of sacral nerve modulation (SNM) in men with fecal incontinence (FI) compared with those of SNM in women. METHOD Prospectively collected data from patients from seven tertiary colorectal units who underwent an implant procedure between January 2010 and December 2015 were reviewed retrospectively. Outcomes and surgical revision and definitive explantation rates were compared between men and women. RESULTS A total of 469 patients (60 men [12.8%]; mean age = 61.4 ± 12.0 years) were included in the study, 352 (78.1%) (31 men [8.8%]) of whom received a permanent implant. The ratio of implanted/tested men was significantly lower than the ratio of implanted/tested women (p = 0.0004). After a mean follow-up of 3.4 ± 1.9 years, the cumulative successful treatment rates tended to be less favorable in men than in women (p = 0.0514): 88.6% (75.6-95.1), 75.9% (60.9-86.4), 63.9% (48.0-77.3), and 43.9% (26.7-62.7) at one, two, three, and five years, respectively, in men; 92.0% (89.1-94.2), 84.2% (80.3-87.4), 76.8% (72.3-80.7), and 63.6% (57.5-69.3) at one, two, three, and five years, respectively, in women. The revision rate for infection and the definitive explantation rate for infection were higher in men than in women (p = 0.0001 and p = 0.0024, respectively). CONCLUSION Both short- and long-term success rates of SNM for FI were lower in men than in women. The revision and definitive explantation for long-term infection rates were significantly higher in men.
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Affiliation(s)
- Charlène Brochard
- Department of Digestive Physiology and Department of Gastroenterology, University Hospital of Rennes Pontchaillou, CIC1414, INPHY, INSERM U1241, University of Rennes 1, Rennes, France
| | - Diane Mege
- Department of Digestive Surgery, Assistance Publique Hôpitaux de Marseille, Timone University Hospital, Marseille, France
| | - Valérie Bridoux
- Normandie Univ, UNIROUEN, Inserm U1073, Rouen University Hospital, Department of Digestive Surgery, Rouen, France
| | - Guillaume Meurette
- Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France
| | - Henri Damon
- Université de Lyon, Hospices Civils de Lyon, Digestive Physiology, Hospital E Herriot, Lyon, France
| | - Elsa Lambrescak
- Department of Coloproctology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France
| | - Jean-Luc Faucheron
- Department of Surgery, Colorectal Unit, Michallon University Hospital, Grenoble, France.,University Grenoble Alps UMR 5525, CNRS, TIMC-IMAG, Grenoble, France
| | - Bertrand Trilling
- Department of Surgery, Colorectal Unit, Michallon University Hospital, Grenoble, France.,University Grenoble Alps UMR 5525, CNRS, TIMC-IMAG, Grenoble, France
| | - Paul-Antoine Lehur
- Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France.,Department of General Surgery, Ospedale Civico di Lugano, Lugano, Switzerland
| | - Vincent Wyart
- Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France
| | - Igor Sielezneff
- Department of Digestive Surgery, Assistance Publique Hôpitaux de Marseille, Timone University Hospital, Marseille, France
| | - François Mion
- Université de Lyon, Hospices Civils de Lyon, Digestive Physiology, Hospital E Herriot, Lyon, France
| | - Isabelle Etienney
- Department of Coloproctology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France
| | - Anne-Marie Leroi
- Normandie Univ, UNIROUEN, Inserm U1073, Rouen University Hospital, Department of Digestive Surgery, Rouen, France
| | - Laurent Siproudhis
- Department of Digestive Physiology and Department of Gastroenterology, University Hospital of Rennes Pontchaillou, CIC1414, INPHY, INSERM U1241, University of Rennes 1, Rennes, France
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Oliveira L, Hagerman G, Torres ML, Lumi CM, Siachoque JAC, Reyes JC, Perez-Aguirre J, Sanchez-Robles JC, Guerrero-Guerrero VH, Regadas SM, Filho VG, Rosato G, Vieira E, Marzan L, Lima D, Londoño-Schimmer E, Wexner SD. Sacral neuromodulation for fecal incontinence in Latin America: initial results of a multicenter study. Tech Coloproctol 2019; 23:545-550. [DOI: 10.1007/s10151-019-02004-y] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2019] [Accepted: 05/13/2019] [Indexed: 12/17/2022]
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Widmann B, Galata C, Warschkow R, Beutner U, Ögredici Ö, Hetzer FH, Schmied BM, Post S, Marti L. Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study. J Neurogastroenterol Motil 2019; 25:159-170. [PMID: 30646487 PMCID: PMC6326196 DOI: 10.5056/jnm17106] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/01/2018] [Revised: 09/28/2018] [Accepted: 10/09/2018] [Indexed: 12/14/2022] Open
Abstract
Background/Aims The aim of this study was to evaluate the sustainability of sacral neuromodulation (SNM) success in patients with fecal incontinence (FI) and/or constipation. Methods This is a retrospective analysis of a prospective database of patients who received SNM therapy for FI and/or constipation between 2006 and 2015. Success rates, complications and reintervention rates were assessed after up to 10 years of follow-up. Results Electrodes for test stimulation were implanted in 101 patients, of whom 79 (78.2%) received permanent stimulation. The mean follow-up was 4.4 ± 3.0 years. At the end of follow-up, 57 patients (72.2%) were still receiving SNM. The 5-year success rate for FI and isolated constipation was 88.2% (95% confidence interval [CI], 80.1-97.0%) and 31.2% (95% CI, 10.2-95.5%), respectively (P ＜ 0.001). In patients with FI, involuntary evacuations per week decreased ＞ 50% in 76.1% of patients (95% CI, 67.6-86.2%) after 5 years. A lead position at S3 was associated with an improved outcome (P = 0.04). Battery exchange was necessary in 23 patients (29.1%), with a median battery life of 6.2 years. Reinterventions due to complications were necessary in 24 patients (30.4%). For these patients, the 5-year success rate was 89.0% (95% CI, 75.3-100.0%) compared to 78.4% (95% CI, 67.2-91.4%) for patients without reintervention. Conclusions SNM offers an effective sustainable treatment for FI. For constipation, lasting success of SNM is limited and is thus not recommended. Reinterventions are necessary but do not impede treatment success.
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Affiliation(s)
- Bernhard Widmann
- Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, Switzerland
| | - Christian Galata
- Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany
| | - Rene Warschkow
- Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, Switzerland.,Institute of Medical Biometry and Informatics, University of Heidelberg, Germany
| | - Ulrich Beutner
- Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, Switzerland
| | - Önder Ögredici
- Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, Switzerland
| | - Franc H Hetzer
- Department of Surgery, Spital Linth, Uznach, Switzerland
| | - Bruno M Schmied
- Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, Switzerland
| | - Stefan Post
- Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany
| | - Lukas Marti
- Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, Switzerland.,Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany
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Kirss J, Pinta T, Varpe P, Rautio T, Kairaluoma M, Hyöty M, Hurme S, Böckelman C, Kairaluoma V, Salmenkylä S, Victorzon M. Outcomes of treatment of faecal incontinence with sacral nerve stimulation - a Finnish multicentre study. Colorectal Dis 2019; 21:59-65. [PMID: 30192431 DOI: 10.1111/codi.14406] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/11/2018] [Accepted: 07/23/2018] [Indexed: 02/08/2023]
Abstract
AIM The aim of this multicentre study is to report the results of sacral nerve stimulation (SNS) treatment for faecal incontinence (FI) in Finland and determine factors that could influence SNS treatment outcomes. METHOD This is a national multicentre study, involving all patients tested for SNS implantation in Finland from 1999 to 2017. Data were collected retrospectively from electronic patient archives and analysed for possible effects on treatment outcome. RESULTS Of the 432 patients with FI tested for SNS, 365 were women. Three hundred and thirteen (72.5%) of the tested patients advanced to permanent implantation of a stimulator. A successful final treatment outcome, with subjective alleviation of FI, was reported by 59.3% of the patients at the end of follow-up (mean 2.4 years, range 8 days to 13.3 years). Patients with obstetric sphincter injury and idiopathic FI had more permanent stimulator implantations than patients with iatrogenic injury (P = 0.012). Male patients had significantly worse test phase outcomes than female patients (P < 0.001). Age did not influence treatment outcome (P = 0.446) CONCLUSION: Subjective final success of SNS treatment for FI was achieved in 59.3% of patients at a mean of 2.4 years. Gender and the aetiology of FI influenced the test phase and final treatment outcome of SNS treatment.
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Affiliation(s)
- J Kirss
- Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.,University of Turku, Turku, Finland
| | - T Pinta
- Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland
| | - P Varpe
- Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland
| | - T Rautio
- Oulu University Hospital, Oulu, Finland
| | - M Kairaluoma
- Central Finland Central Hospital, Jyväskylä, Finland
| | - M Hyöty
- Tampere University Hospital, Tampere, Finland
| | - S Hurme
- University of Turku, Turku, Finland.,Department of Biostatistics, University of Turku, Turku, Finland
| | - C Böckelman
- Helsinki University Hospital, Helsinki, Finland
| | | | | | - M Victorzon
- University of Turku, Turku, Finland.,Department of Surgery, Vaasa Central Hospital, Vaasa, Finland
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Sacral Nerve Stimulation as a Therapy for Patients With Refractory Voiding and Bowel Dysfunction. Obstet Gynecol 2018; 132:1337-1345. [DOI: 10.1097/aog.0000000000002968] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
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47
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Matzel KE, Bittorf B. Reprint of: Management of fecal incontinence: Surgical treatement. SEMINARS IN COLON AND RECTAL SURGERY 2018. [DOI: 10.1053/j.scrs.2018.11.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
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Hounsome N, Roukas C. Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence. Therap Adv Gastroenterol 2018; 11:1756284818802562. [PMID: 30305847 PMCID: PMC6176537 DOI: 10.1177/1756284818802562] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2018] [Accepted: 08/23/2018] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND Subcutaneous sacral nerve stimulation is recommended by the United Kingdom (UK) National Institute for Health and Care Excellence (NICE) as a second-line treatment for patients with faecal incontinence who failed conservative therapy. Sacral nerve stimulation is an invasive procedure associated with complications and reoperations. This study aimed to investigate whether delivering less invasive and less costly percutaneous tibial nerve stimulation prior to sacral nerve stimulation is cost-effective. METHODS A decision analytic model was developed to estimate the cost-effectiveness of percutaneous tibial nerve stimulation with subsequent subcutaneous sacral nerve stimulation versus subcutaneous sacral nerve stimulation alone. The model was populated with effectiveness data from systematic reviews and cost data from randomized studies comparing both procedures in a UK National Health Service (NHS) setting. RESULTS Offering percutaneous tibial nerve stimulation prior to sacral nerve stimulation (compared with delivering sacral nerve stimulation straight away) was both more effective and less costly in all modeled scenarios. The estimated savings from offering percutaneous tibial nerve stimulation first were £662-£5,697 per patient. The probability of this strategy being cost-effective was around 80% at £20,000-£30,000 per quality-adjusted life-year (QALY). CONCLUSION Our analyses suggest that offering patients percutaneous tibial nerve stimulation prior to sacral nerve stimulation can be both cost-effective and cost-saving in the treatment of faecal incontinence.
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Affiliation(s)
| | - Chris Roukas
- Pragmatic Clinical Trials Unit, Queen Mary
University of London, London, UK
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Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, Rosenbluth JP, Presson AP, Myers JB. Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury. BMC Urol 2018; 18:72. [PMID: 30157824 PMCID: PMC6116487 DOI: 10.1186/s12894-018-0383-y] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2018] [Accepted: 08/06/2018] [Indexed: 11/10/2022] Open
Abstract
Background Neurogenic bladder (NGB) dysfunction after spinal cord injury (SCI) is generally irreversible. Preliminary animal and human studies have suggested that initiation of sacral neuromodulation (SNM) immediately following SCI can prevent neurogenic detrusor overactivity and preserve bladder capacity and compliance. We designed a multicenter randomized clinical trial to evaluate the effectiveness of early SNM after acute SCI. Methods/Design The scientific protocol comprises a multi-site, randomized, non-blinded clinical trial. Sixty acute, acquired SCI patients (30 per arm) will be randomized within 12 weeks of injury. All participants will receive standard care for NGB including anticholinergic medications and usual bladder management strategies. Those randomized to intervention will undergo surgical implantation of the Medtronic PrimeAdvanced Surescan 97,702 Neurostimulator with bilateral tined leads along the S3 nerve root in a single-stage procedure. All patients will undergo fluoroscopic urodynamic testing at study enrollment, 3 months, and 1-year post randomization. The primary outcome will be changes in urodynamic maximum cystometric capacity at 1-year. After accounting for a 15% loss to follow-up, we expect 25 evaluable patients per arm (50 total), which will allow detection of a 38% treatment effect. This corresponds to an 84 mL difference in bladder capacity (80% power at a 5% significance level). Additional parameters will be assessed every 3 months with validated SCI-Quality of Life questionnaires and 3-day voiding diaries with pad-weight testing. Quantified secondary outcomes include: patient reported QoL, number of daily catheterizations, incontinence episodes, average catheterization volume, detrusor compliance, presence of urodynamic detrusor overactivity and important clinical outcomes including: hospitalizations, number of symptomatic urinary tract infections, need for further interventions, and bowel and erectile function. Discussion This research protocol is multi-centered, drawing participants from large referral centers for SCI and has the potential to increase options for bladder management after SCI and add to our knowledge about neuroplasticity in the acute SCI patient. Trial registration ClinicalTrials.gov #NCT03083366 1/27/2017.
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Affiliation(s)
- Jeffrey D Redshaw
- Department of Surgery, Division of Urology, University of Utah School of Medicine, 30 N. 1900 E. 3B110, Salt Lake City, UT, 84132, USA.
| | - Sara M Lenherr
- Department of Surgery, Division of Urology, University of Utah School of Medicine, 30 N. 1900 E. 3B110, Salt Lake City, UT, 84132, USA
| | - Sean P Elliott
- Department of Urology, University of Minnesota, Minneapolis, MN, USA
| | - John T Stoffel
- Department of Urology, University of Michigan, Ann Arbor, MI, USA
| | - Jeffrey P Rosenbluth
- University of Utah School of Medicine, Physical Medicine and Rehabilitation, Salt Lake City, UT, USA
| | - Angela P Presson
- Division of Epidemiology, University of Utah, Salt Lake City, UT, USA
| | - Jeremy B Myers
- Department of Surgery, Division of Urology, University of Utah School of Medicine, 30 N. 1900 E. 3B110, Salt Lake City, UT, 84132, USA
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50
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La neuromodulation sacrée dans la vraie vie : suivi correct exigé ! Presse Med 2018; 47:700-701. [DOI: 10.1016/j.lpm.2018.04.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2018] [Accepted: 04/09/2018] [Indexed: 11/19/2022] Open
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