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Tur-Martinez J, Lagares-Tena L, Hinojosa-Fano J, Arroyo A, Navarro-Luna A, Muñoz-Duyos A. Gatekeeper™ Prostheses Implants in the Anal Canal for Gas Incontinence and Soiling: Long-Term Follow-Up. J Clin Med 2024; 13:6156. [PMID: 39458106 PMCID: PMC11508701 DOI: 10.3390/jcm13206156] [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: 08/27/2024] [Revised: 09/24/2024] [Accepted: 10/14/2024] [Indexed: 10/28/2024] Open
Abstract
Introduction: Although several treatments for faecal incontinence are available, gas incontinence (GI) and soiling are difficult to manage. The aim of this study is to evaluate Gatekeeper™ for this subtype of faecal incontinence. Methods: Prospective single-centre case series. Patients with mainly soiling and/or GI were treated with polyacrylonitrile prostheses. An evaluation was performed with a 3-week continence diary. St. Mark's score and a Visual Analogue Scale (VAS) were used to study the patient's continence perception and surgical satisfaction, at baseline and 1, 3, 6, 12, and 24 months postoperatively. 3D-Endoanal Ultrasound and Anorectal Manometry were performed at baseline and postoperatively. Results: A total of 13 patients were enrolled (11 women), aged (median (IQR)) 62 (13) years, and all implants were uneventful. A significant reduction in soiling and GI episodes was documented at 1 year, 7 (18) baseline days of soiling/3 weeks vs. 2 (4) (p = 0.002); 13 (13) baseline episodes of GI/3 weeks vs. 4 (10) (p = 0.01). This improvement was correlated with a significant increase in VAS (0-10), 3 (2, 5) baseline vs. 7 (1, 5) (p = 0.03), and maintained throughout the follow-up. There was complete remission or significant improvement defined as >70% reduction in gas and soiling days in 6 patients at 2 years follow-up. Soiling episodes were reduced ≥70% in 8/11 patients (72.7%). Nine (70%) patients would repeat the treatment. Conclusions: Gatekeeper™ is a safe, minimally invasive treatment for soiling and GI. A significant reduction in soiling and GI was observed in our series, with a better response to soiling. Most of the patients would repeat the treatment. Other studies are needed to confirm these findings in this subgroup of FI patients.
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Affiliation(s)
- Jaume Tur-Martinez
- Department of General Surgery, Hospital Universitari MútuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain
| | - Laura Lagares-Tena
- Department of General Surgery, Hospital Universitari MútuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain
| | - Juan Hinojosa-Fano
- Department of General Surgery, Hospital Universitari MútuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain
| | - Antonio Arroyo
- Colorectal Surgery Unit, Department of General Surgery, Hospital Universitario de Elche, Universidad Miguel Hernández, 03202 Elche, Spain
| | - Albert Navarro-Luna
- Department of General Surgery, Hospital Universitari MútuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain
| | - Arantxa Muñoz-Duyos
- Department of General Surgery, Hospital Universitari MútuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain
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Role of Autologous Fat Grafting in the Conservative Treatment of Fecal Incontinence in Children. J Clin Med 2023; 12:jcm12041258. [PMID: 36835794 PMCID: PMC9964968 DOI: 10.3390/jcm12041258] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2022] [Revised: 01/25/2023] [Accepted: 01/31/2023] [Indexed: 02/08/2023] Open
Abstract
Treatment of organic fecal incontinence in children, typical of anorectal malformations, is most often conservative; however, when necessary, it can be surgical. Autologous fat grafting, or lipofilling, can be used to improve fecal incontinence. We present our experience with the echo-assisted anal-lipofilling and its effects on fecal incontinence in children and on the quality of life of the entire family. Under general anesthesia, fat tissue was harvested according to the traditional technique, and processed in a closed system Lipogems® set. Injection of the processed adipose tissue was guided by trans-anal ultrasound assistance. Ultrasound and manometry were also used for follow-up. From November 2018, we performed 12 anal-lipofilling procedures in six male patients (mean age 10.7 years). Five children had a stable improvement in bowel function with Krickenbeck's scale scores going from soiling grade 3 pre-treatment in 100% of children to grade 1 post-treatment in 75% of them. No major post-operative complications developed. An increase in thickness of the sphincteric apparatus was shown at ultrasound during follow-up. The quality of life of the entire family, evaluated with a questionnaire, improved after the surgical treatment of the children. Anal-lipofilling is a safe and effective procedure to reduce organic fecal incontinence thereby benefiting both the patients and their families.
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Jabbar SAA, Camilleri-Brennan J. An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence. Tech Coloproctol 2022; 26:537-543. [PMID: 35593969 PMCID: PMC9213285 DOI: 10.1007/s10151-022-02630-z] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2021] [Accepted: 05/02/2022] [Indexed: 11/26/2022]
Abstract
Background Implantation of Gatekeeper™ prostheses presents an option for the treatment of passive faecal incontinence (FI). Whilst preliminary results are encouraging, long-term data regarding its sustained benefit are limited. The aim of this study was to assess and evaluate the long-term clinical function and quality of life of patients with passive faecal incontinence who were treated with Gatekeeper™ prostheses. Methods This was a single centre, single surgeon retrospective study of prospectively collected clinical data in patients with FI treated between June 2012 and May 2019. Patients with passive FI with symptoms refractory to conservative treatment and endoanal ultrasonography showing intact or disrupted internal anal sphincter were included. Formal clinical and quality of life assessments were carried out using the St. Mark’s Incontinence Score (SMIS) and Faecal Incontinence Quality of Life (FIQoL) questionnaires at baseline, 3 months, 6 months, 12 months and then annually. Endoanal ultrasonography was performed both before and after surgery. Results Forty patients (14 males, 26 females) with a median age of 62.5 (range 33–80) years were treated with the Gatekeeper™ implant. The majority of patients (87.5%) received six implants. There were no peri or post-operative complications. Prosthesis migration was observed in 12.5% patients. The median follow-up duration was 5 years (interquartile range (IQR) 3.25–6.00 years). A sustained improvement in median SMIS and FIQoL scores from baseline to follow-up was noted. Significant differences were observed between the median baseline SMIS score and last follow-up score of 16.00 (IQR 15.00–16.75) to 7.00 (IQR 5.00–8.00) respectively (p < 0.001), a 56.25% decrease. The overall median FIQoL score showed a significant improvement from 7.95 (IQR 7.13–9.48) to 13.15 (IQR 12.00–13.98) (p < 0.001) a 65.40% increase. Conclusions Gatekeeper™ implantation is a safe approach to treating passive FI and is minimally invasive, reproducible and has minimal complications. Long-term sustained clinical improvement is achievable beyond 5 years. Careful patient selection is paramount, as is consistency of technique and follow-up protocol.
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Affiliation(s)
- S A A Jabbar
- Department of Colorectal Surgery, Forth Valley Royal Hospital, Larbert, Stirlingshire, Scotland, UK
| | - J Camilleri-Brennan
- Department of Colorectal Surgery, Forth Valley Royal Hospital, Larbert, Stirlingshire, Scotland, UK.
- Department of Surgery, University of Glasgow, Glasgow, Scotland, UK.
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Ivatury SJ, Wilson LR, Paquette IM. Surgical Treatment Alternatives to Sacral Neuromodulation for Fecal Incontinence: Injectables, Sphincter Repair, and Colostomy. Clin Colon Rectal Surg 2021; 34:40-48. [PMID: 33536848 DOI: 10.1055/s-0040-1714285] [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: 10/22/2022]
Abstract
Fecal incontinence is a prevalent health problem that affects over 20% of healthy women. Many surgical treatment options exist for fecal incontinence after attempts at non-operative management. In this article, the authors discuss surgical treatment options for fecal incontinence other than sacral neuromodulation.
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Affiliation(s)
- Srinivas Joga Ivatury
- Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.,Geisel School of Medicine, Lebanon, New Hampshire
| | - Lauren R Wilson
- Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.,Geisel School of Medicine, Lebanon, New Hampshire
| | - Ian M Paquette
- University of Cincinnati Surgeons, College of Medicine, Cincinnati, Ohio
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Jeong H, Hwang SH, Kim HR, Ryu KO, Lim J, Yu HM, Yoon J, Kim CY, Jeong KY, Jung YJ, Jeong IS, Choi YG. Effectiveness of Autologous Fat Graft in Treating Fecal Incontinence. Ann Coloproctol 2019; 35:144-151. [PMID: 31288503 PMCID: PMC6625772 DOI: 10.3393/ac.2018.09.15] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/11/2018] [Accepted: 09/15/2018] [Indexed: 12/22/2022] Open
Abstract
Purpose The most common risk factor for fecal incontinence (FI) is obstetric injury. FI affects 1.4%–18% of adults. Most patients are unaware when they are young, when symptoms appear suddenly and worsen with aging. Autologous fat graft is widely used in cosmetic surgical field and may substitute for injectable bulky agents in treating FI. Authors have done fat graft for past several years. This article reports the effectiveness of the fat graft in treating FI and discusses satisfaction with the procedure. Methods Fat was harvested from both lateral thighs using 10-mL Luer-loc syringe. Pure fat was extracted from harvests and mixed with fat, oil, and tumescent through refinement. Fats were injected into upper border of posterior ano-rectal ring, submucosa of anal canal and intersphincteric space. Thirty-five patients with FI were treated with this method from July 2016 to February 2017 in Busan Hangun Hospital. They were 13 male (mean age, 60.8 years) and 22 female patients (mean age, 63.3 years). The Wexner score was checked before procedure. We evaluated outcome in outpatients by asking the patients. For 19 patients we checked the Wexner score after procedure. Results Symptom improved in 29 (82.9%), and not improved in 6 (17.1%). In 2 of 6 patients, they felt better than before procedure, although not satisfied. No improvement in 4. Mean Wexner score was 9.7 before procedure. There were no serious complications such as inflammation or fat embolism. Conclusion Autologous fat graft can be an effective alternative treatment for FI. It is safe and easy to perform, and cost effective.
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Affiliation(s)
| | | | - Hyoung Rae Kim
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | - Kil O Ryu
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | - Jiyong Lim
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | - Hye Mi Yu
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | - Jihoon Yoon
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | - Chee Young Kim
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | | | - Young Jae Jung
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | - In Seob Jeong
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
| | - Young Gil Choi
- Department of Surgery, Busan Hangun Hospital, Busan, Korea
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de la Portilla F, Reyes-Díaz ML, Maestre MV, Jiménez-Rodríguez RM, García-Cabrera AM, Vázquez-Monchul JM, Díaz-Pavón JM, Padillo-Ruiz FC. Ultrasonographic evidence of Gatekeeper™ prosthesis migration in patients treated for faecal incontinence: a case series. Int J Colorectal Dis 2017; 32:437-440. [PMID: 28054134 DOI: 10.1007/s00384-016-2742-z] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 12/19/2016] [Indexed: 02/04/2023]
Abstract
BACKGROUND Faecal incontinence (FI) is both a medical and social problem, with an underestimated incidence. For patients with internal anal sphincter damage, implantation of biomaterial in the anal canal is a recognised treatment option. One such material, Gatekeeper™, has previously shown promising short- and medium-term results without any major complications, including displacement. The main aim of the present study is to assess the degree to which displacement of Gatekeeper prostheses may occur and to determine whether this is associated with patient outcomes. METHODS Seven patients (six females) with a mean age of 55.6 years [50.5-57.2] and a mean FI duration of 6 ± 2 years were prospectively enrolled in the study. Each subject was anaesthetised and underwent implantation of six prostheses in the intersphincteric region, guided by endoanal 3D ultrasound (3D-EAU). Follow-up was performed at post-interventional months 1, 3, and 12 (median 12 ± 4 months), during which data were obtained from a defaecation diary, Wexner scale assessment, anorectal manometry (ARM), 3D-EAU, and a health status and quality of life questionnaire (FIQL). RESULTS At 3-month follow-up, 3D-EAU revealed displacement of 24/42 prostheses in 5/7 patients. Of these, 15 had migrated to the lower portion and 9 to the upper portion of the anal canal and rectum. Despite this migration, treatment was considered successful in 3/7 patients. In one patient, it was necessary to remove a prosthesis due to spontaneous extrusion. CONCLUSIONS We have shown that displacement of the Gatekeeper™ prosthesis occurs, but is not associated with poorer clinical outcomes.
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Affiliation(s)
- F de la Portilla
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain. .,Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD o Ciberehd), Instituto de Salud Carlos III, Madrid, Spain.
| | - M L Reyes-Díaz
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain
| | - M V Maestre
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain
| | - R M Jiménez-Rodríguez
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain
| | - A M García-Cabrera
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain
| | - J M Vázquez-Monchul
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain
| | - J M Díaz-Pavón
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain
| | - F C Padillo-Ruiz
- Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain
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Affiliation(s)
- Doo Han Lee
- Department of Colon and Rectal Surgery, Daehang hospital, Seoul, Korea
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Al-Abed YA, Ayers J, Ayantunde A, Praveen BV. Safety and Efficacy of Permacol Injection in the Treatment of Fecal Incontinence. Ann Coloproctol 2016; 32:73-8. [PMID: 27218098 PMCID: PMC4865468 DOI: 10.3393/ac.2016.32.2.73] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2016] [Accepted: 03/02/2016] [Indexed: 11/23/2022] Open
Abstract
Purpose Permacol has been gaining popularity in recent times for the treatment of fecal incontinence (FI). This study aims to evaluate the safety and efficacy of anal submucosal Permacol injection in the treatment of FI. Methods All consecutive patients who underwent Permacol injection for FI over a 3-year period were included. Patients' data relating to obstetric history, anorectal/pelvic operations, type of FI, preoperative anorectal physiology results and follow-up details for outcome measures were collected. Preoperative and postoperative Cleveland Clinic Florida Incontinence Scores (CCFISs) were noted. Patients were surveyed by using a telephone questionnaire to assess the quality of life and other outcome measures. Data were analysed using SPSS ver.19.0. Results Thirty patients (28 females and 2 males) with a median age of 67 years were included in the study. Of those patients, 37%, 50%, and 13% were noted to have passive, mixed and urge FI, respectively. Six of the patients (20%) had repeat Permacol injections, 5 of whom had sustained responses to the first Permacol injection for a mean of 11 months. There was a significant improvement in the CCFIS from a baseline median of 12.5, mean 12.8 interquartile range [IQR], 6–20), to a median of 3.5, mean 4.8 (IQR, 0–20), P < 0.001. Of the patients surveyed by telephone 89% were satisfied with their overall experience and the improvement in their symptoms following Permacol injections. Conclusion This study has demonstrated that Permacol injection for the treatment of FI is safe and effective and has no associated major complications. However, the results are not permanent; consequently, a significant proportion of the patients with an initial response may require repeat injections.
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Affiliation(s)
- Yahya A Al-Abed
- Department of Colorectal Surgery, Southend University Hospital, Westcliff on Sea, United Kingdom
| | - Jennifer Ayers
- Department of Colorectal Surgery, Southend University Hospital, Westcliff on Sea, United Kingdom
| | - Abraham Ayantunde
- Department of Colorectal Surgery, Southend University Hospital, Westcliff on Sea, United Kingdom
| | - Bandipalyam V Praveen
- Department of Colorectal Surgery, Southend University Hospital, Westcliff on Sea, United Kingdom
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Ratto C, Buntzen S, Aigner F, Altomare DF, Heydari A, Donisi L, Lundby L, Parello A. Multicentre observational study of the Gatekeeper for faecal incontinence. Br J Surg 2015; 103:290-9. [PMID: 26621029 PMCID: PMC5063193 DOI: 10.1002/bjs.10050] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2015] [Revised: 07/24/2015] [Accepted: 10/07/2015] [Indexed: 12/13/2022]
Abstract
Background A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper™ prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper™ implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation. Methods Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow‐up. Results Fifty‐four patients were implanted. After Gatekeeper™ implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required. Conclusion Anal implantation of the Gatekeeper™ in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1‐year follow‐up. GatekeeperTM effective
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Affiliation(s)
- C. Ratto
- Proctology Unit, Department of Surgical SciencesCatholic UniversityRomeItaly
| | - S. Buntzen
- Department of Surgery PAarhus University HospitalAarhusDenmark
| | - F. Aigner
- Department of Visceral, Transplant and Thoracic SurgeryInnsbruck Medical UniversityInnsbruckAustria
- Department of General, Visceral and Transplant SurgeryCharité Universitätsmedizin BerlinCampus Virchow‐KlinikumBerlinGermany
| | - D. F. Altomare
- Department of Emergency and Organ Transplantation, General Surgery UnitUniversity of BariBariItaly
| | - A. Heydari
- Department of General SurgeryNuovo Ospedale Civile Sant'Agostino EstenseModenaItaly
| | - L. Donisi
- Proctology Unit, Department of Surgical SciencesCatholic UniversityRomeItaly
| | - L. Lundby
- Department of Surgery PAarhus University HospitalAarhusDenmark
| | - A. Parello
- Proctology Unit, Department of Surgical SciencesCatholic UniversityRomeItaly
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Abstract
BACKGROUND Anal incontinence is a common and multifactorial pathology that affects patients' lives and imposes considerable socioeconomic consequences. OBJECTIVE The aim of this study is to evaluate the efficacy of a bulking agent, polyacrylate-polyalcohol (PP), in terms of diminishing the severity of incontinence and improving the patient's quality of life, assessing any adverse events. DESIGN Data were obtained through a prospective, nonconsecutive, multicenter, noncomparative, postmarket study with a maximum expected follow-up of 3 years. Four investigational centers from Argentina and Brazil participated in this study. SETTINGS Injections of the bulking agent were administered in the operating room of tertiary hospitals. PATIENTS Fifty-eight patients were enrolled. Five patients were lost to follow-up. Of the remaining 53 patients, 41 (77.4%) were females. All patients scored between 6 and 12 on the Cleveland Clinic Florida-Fecal Incontinence Score as part of the inclusion criteria. INTERVENTIONS The injection of the bulking agent (PP) was administered under intravenous sedation in the submucosa of the anal canal through the perianal skin to generate a bulk. MAIN OUTCOME MEASURES The primary efficacy end point was the Cleveland Clinic Florida-Fecal Incontinence Score (or Jorge and Wexner index). The Rockwood-Fecal Incontinence Quality of Life index was also recorded. The treatment was considered successful if patients achieved a postoperative improvement of at least 50% on the Cleveland Clinic Florida-Fecal Incontinence Score. RESULTS Successful treatment was met by 60.4% of the patients according to the last follow-up data. Quality-of-life indices showed consistently significant improvements. LIMITATIONS Selection bias and the lack of a control group to evaluate the potential placebo effect of this novel bulking agent were limitations of this study. Because of the eligibility criteria, the resulting patient sample is representative of only a limited portion of the population with fecal incontinence at all 4 centers involved in this study. CONCLUSIONS The injection technique was easy to perform, safe, and ideal for use as an outpatient procedure. This bulking agent (PP) significantly improved continence and quality of life in selected patients.
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Abstract
Fecal incontinence (FI) is a multifactorial disorder that imposes considerable social and economic burdens. The aim of this article is to provide an overview of current and emerging treatment options for FI. A MEDLINE search was conducted for English-language articles related to FI prevalence, etiology, diagnosis, and treatment published from January 1, 1990 through June 1, 2013. The search was extended to unpublished trials on ClinicalTrials.gov and relevant publications cited in included articles. Conservative approaches, including dietary modifications, medications, muscle-strengthening exercises, and biofeedback, have been shown to provide short-term benefits. Transcutaneous electrical stimulation was considered ineffective in a randomized clinical trial. Unlike initial studies, sacral nerve stimulation has shown reasonable short-term effectiveness and some complications. Dynamic graciloplasty and artificial sphincter and bowel devices lack randomized controlled trials and have shown inconsistent results and high rates of explantation. Of injectable bulking agents, dextranomer microspheres in non-animal stabilized hyaluronic acid (NASHA Dx) has shown significant improvement in incontinence scores and frequency of incontinence episodes, with generally mild adverse effects. For the treatment of FI, conservative measures and biofeedback therapy are modestly effective. When conservative therapies are ineffective, invasive procedures, including sacral nerve stimulation, may be considered, but they are associated with complications and lack randomized, controlled trials. Bulking agents may be an appropriate alternative therapy to consider before more aggressive therapies in patients who fail conservative therapies.
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Salcedo L, Penn M, Damaser M, Balog B, Zutshi M. Functional outcome after anal sphincter injury and treatment with mesenchymal stem cells. Stem Cells Transl Med 2014; 3:760-7. [PMID: 24797828 DOI: 10.5966/sctm.2013-0157] [Citation(s) in RCA: 38] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
This research demonstrates the regenerative effects of mesenchymal stem cells (MSCs) on the injured anal sphincter by comparing anal sphincter pressures following intramuscular and serial intravascular MSC infusion in a rat model of anal sphincter injury. Fifty rats were divided into injury (n = 35) and no injury (NI; n = 15) groups. Each group was further divided into i.m., serial i.v., or no-treatment (n = 5) groups and followed for 5 weeks. The injury consisted of an excision of 25% of the anal sphincter complex. Twenty-four hours after injury, 5 × 10(5) green fluorescent protein-labeled MSCs in 0.2 ml of phosphate-buffered saline (PBS) or PBS alone (sham) were injected into the anal sphincter for i.m. treatment; i.v. and sham i.v. treatments were delivered daily for 6 consecutive days via the tail vein. Anal pressures were recorded before injury and 10 days and 5 weeks after treatment. Ten days after i.m. MSC treatment, resting and peak pressures were significantly increased compared with those in sham i.m. treatment (p < .001). When compared with the NI group, the injury groups had anal pressures that were not significantly different 5 weeks after i.m./i.v. treatment. Both resting and peak pressures were also significantly increased after i.m./i.v. MSC treatment compared with treatment with PBS (p < .001), suggesting recovery. Statistical analysis was done using paired t test with Bonferroni correction. Marked decrease in fibrosis and scar tissue was seen in both MSC-treated groups. Both i.m. and i.v. MSC treatment after injury caused an increase in anal pressures sustained at 5 weeks, although fewer cells were injected i.m. The MSC-treated groups showed less scarring than the PBS-treated groups, with the i.v. infusion group showing the least scarring.
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Affiliation(s)
- Levilester Salcedo
- Department of Colorectal Surgery and Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA; Summa Cardiovascular Institute and Northeast Ohio Medical University, Akron, Ohio, USA; Advanced Platform Technology Center, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio, USA
| | - Marc Penn
- Department of Colorectal Surgery and Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA; Summa Cardiovascular Institute and Northeast Ohio Medical University, Akron, Ohio, USA; Advanced Platform Technology Center, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio, USA
| | - Margot Damaser
- Department of Colorectal Surgery and Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA; Summa Cardiovascular Institute and Northeast Ohio Medical University, Akron, Ohio, USA; Advanced Platform Technology Center, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio, USA
| | - Brian Balog
- Department of Colorectal Surgery and Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA; Summa Cardiovascular Institute and Northeast Ohio Medical University, Akron, Ohio, USA; Advanced Platform Technology Center, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio, USA
| | - Massarat Zutshi
- Department of Colorectal Surgery and Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio, USA; Summa Cardiovascular Institute and Northeast Ohio Medical University, Akron, Ohio, USA; Advanced Platform Technology Center, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio, USA
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Abstract
Sphincteroplasty (SP) is the operation most frequently performed in patients suffering from moderate-to-severe anal incontinence (AI) who do not respond to conservative treatment. Other costly surgeries, such as artificial bowel sphincter (ABS) and electro-stimulated graciloplasty, have been more or less abandoned due to their high morbidity rate. Minimally invasive procedures are widely used, such as sacral neuromodulation and injection of bulking agents, but both are costly and the latter may cure only mild incontinence. The early outcome of SP is usually good if the sphincters are not markedly denervated, but its effect diminishes over time. SP is more often performed for post-traumatic than for idiopathic AI. It may also be associated to the Altemeier procedure, aimed at reducing the recurrence rate of rectal prolapse, and may be useful when AI is due either to injury to the sphincter, or to a narrowed rectum following the procedure for prolapse and haemorrhoids (PPH) and stapled transanal rectal resection (STARR). The outcome of SP is likely to be improved with biological meshes and post-operative pelvic floor rehabilitation. SP is more effective in males than in multiparous women, whose sphincters are often denervated, and its post-operative morbidity is low. In conclusion, SP, being both low-cost and safe, remains a good option in the treatment of selected patients with AI.
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Frascio M, Mandolfino F, Imperatore M, Stabilini C, Fornaro R, Gianetta E, Wexner SD. The SECCA procedure for faecal incontinence: a review. Colorectal Dis 2014; 16:167-72. [PMID: 24034552 DOI: 10.1111/codi.12403] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2013] [Accepted: 08/03/2013] [Indexed: 12/13/2022]
Abstract
AIM The SECCA system is a treatment option for patients with faecal incontinence and was introduced into clinical practice in 2002. Clinical studies of radiofrequency energy to treat patients with faecal incontinence have been published. This article aimed to review all published series to assess the results of this treatment. METHOD Twelve studies were included. Outcomes analysed included quality of life, the Wexner incontinence score, anorectal manometry and endoanal ultrasound findings. RESULTS A total of 220 patients from 10 studies were included. In the majority of clinical studies, the SECCA procedure has been shown to be an effective treatment of mild-to-moderate faecal incontinence. CONCLUSION When patient selection is appropriate, this treatment has demonstrated clinically significant improvements in symptoms, as demonstrated by statistically significant reductions in the Wexner incontinence and quality of life scores.
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Affiliation(s)
- M Frascio
- Patologia Chirurgica ad Indirizzo Gastroenterologico, DISC-Department of Surgical Sciences and Integrated Methodologies, School of Medical and Pharmaceutical Sciences, University of Genova, Genova, Italy
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15
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Bisson A, Fréret M, Drouot L, Jean L, Le Corre S, Gourcerol G, Doucet C, Michot F, Boyer O, Lamacz M. Restoration of anal sphincter function after myoblast cell therapy in incontinent rats. Cell Transplant 2013; 24:277-86. [PMID: 24143883 DOI: 10.3727/096368913x674053] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022] Open
Abstract
Fecal incontinence (FI) remains a socially isolating condition with profound impact on quality of life for which autologous myoblast cell therapy represents an attractive treatment option. We developed an animal model of FI and investigated the possibility of improving sphincter function by intrasphincteric injection of syngeneic myoblasts. Several types of anal cryoinjuries were evaluated on anesthetized Fischer rats receiving analgesics. The minimal lesion yielding sustainable anal sphincter deficiency was a 90° cryoinjury of the sphincter, repeated after a 24-h interval. Anal sphincter pressure was evaluated longitudinally by anorectal manometry under local electrostimulation. Myoblasts were prepared using a protocol mimicking a clinical-grade process and further transduced with a GFP-encoding lentiviral vector before intrasphincteric injection. Experimental groups were uninjured controls, cryoinjured + PBS, and cryoinjured + myoblasts (different doses or injection site). Myoblast injection was well tolerated. Transferred myoblasts expressing GFP integrated into the sphincter and differentiated in situ into dystrophin-positive mature myofibers. Posttreatment sphincter pressures increased over time. At day 60, pressures in the treated group were significantly higher than those of PBS-injected controls and not significantly different from those of normal rats. Longitudinal follow-up showed stability of the therapeutic effect on sphincter function over a period of 6 months. Intrasphincteric myoblast injections at the lesion borders were equally as effective as intralesion administration, but an injection opposite to the lesion was not. These results provide proof of principle for myoblast cell therapy to treat FI in a rat model. This strategy is currently being evaluated in humans in a randomized double-blind placebo-controlled clinical trial.
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Morris OJ, Smith S, Draganic B. Comparison of bulking agents in the treatment of fecal incontinence: a prospective randomized clinical trial. Tech Coloproctol 2013; 17:517-23. [PMID: 23525964 DOI: 10.1007/s10151-013-1000-4] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/02/2012] [Accepted: 03/01/2013] [Indexed: 12/17/2022]
Abstract
BACKGROUND We sought to compare two synthetic injectable bulking agents, with known efficacy (PTQ™: a silicone biomaterial and Durasphere(®): pyrolytic carbon-coated beads), in the form of a randomised clinical trial. METHODS Circumferential injection of either agent was performed under local anesthesia and sedation as a day-case procedure. The primary outcome measure was the Wexner incontinence scale. Secondary measures were the short-form 36 (SF-36) quality of life assessment and manometry (maximum resting and squeeze pressures). Follow-up was at 6 weeks, 6 and 12 months. RESULTS Thirty-five patients were randomised, 17 to PTQ(®) and 18 to Durasphere(®). Early closure of the trial occurred, due to the removal of the agent PTQ(®), from the Australian Pharmaceutical Benefits scheme. Wexner incontinence scores were significantly better than baseline, in both groups, at 6 weeks and 6 months (P < 0.05), although the improvements were not significant at 12 months. There was no significant improvement for either agent, from baseline, in mean SF-36 scores at any follow-up sessions. There was no significant difference between the two bulking agents, with regard to both Wexner and SF-36 scores, at any of the follow-up sessions. Complications occurred in one patient in the PTQ group (perianal abscess) and did not occur in any of the patients in the Durasphere group. CONCLUSIONS This trial appears to show that both synthetic agents PTQ(®) and Durasphere(®) are effective and safe, although long-term improvement is limited. In this trial, there appears to be no difference in efficacy between the two agents, over a 12-month follow-up period.
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Affiliation(s)
- O J Morris
- Hunter Colorectal Research, Newcastle Hospital Private Suites, New Lambton Heights, NSW, 2305, Australia,
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17
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Danielson J, Karlbom U, Wester T, Graf W. Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents. Tech Coloproctol 2012; 17:389-95. [PMID: 23224913 DOI: 10.1007/s10151-012-0949-8] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/30/2012] [Accepted: 11/07/2012] [Indexed: 12/17/2022]
Abstract
BACKGROUND Stabilized non-animal hyaluronic acid/dextranomer (NASHA Dx) gel as injectable bulking therapy has been shown to decrease symptoms of faecal incontinence, but the durability of treatment and effects and influence on quality of life (QoL) is not known. The aim of this study was to assess the effects on continence and QoL and to evaluate the relationship between QoL and efficacy up to 2 years after treatment. METHODS Thirty-four patients (5 males, mean age 61, range 34-80) were injected with 4 × 1 ml NASHA Dx in the submucosal layer. The patients were followed for 2 years with registration of incontinence episodes, bowel function and QoL questionnaires. RESULTS Twenty-six patients reported sustained improvement after 24 months. The median number of incontinence episodes before treatment was 22 and decreased to 10 at 12 months (P = 0.0004) and to 7 at 24 months (P = 0.0026). The corresponding Miller incontinence scores were 14, 11 (P = 0.0078) and 10.5 (P = 0.0003), respectively. There was a clear correlation between the decrease in the number of leak episodes and the increase in the SF-36 Physical Function score but only patients with more than 75 % improvement in the number of incontinence episodes had a significant improvement in QoL at 24 months. CONCLUSIONS Anorectal injection of NASHA Dx gel induces improvement of incontinence symptoms for at least 2 years. The treatment has a potential to improve QoL. A 75 % decrease in incontinence episodes may be a more accurate threshold to indicate a successful incontinence treatment than the more commonly used 50 %.
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Affiliation(s)
- J Danielson
- Institution of Surgical Sciences, Uppsala University, Uppsala, Sweden.
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18
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Craig JB, Lane FL, Nistor G, Motakef S, Pham QA, Keirstead H. Allogenic myoblast transplantation in the rat anal sphincter. Female Pelvic Med Reconstr Surg 2012; 16:205-8. [PMID: 22453342 DOI: 10.1097/spv.0b013e3181ec1edd] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
OBJECTIVES : To determine the feasibility of injecting rat myoblasts into the intact anal sphincter as a potential treatment for anal incontinence, and to detect transferred myoblast survival and integration. STUDY DESIGN : A pilot study using nonpregnant female Sprague Dawley rodents of 8 to 10 weeks of age. A biopsy of skeletal muscle was harvested from a study animal and recovered myoblasts were expanded in vitro over 10 days. Myoblasts were then tagged with a cytomegalovirus promoter to transduce green fluorescent protein (GFP) into the myoblasts. The cell aspirate was injected directly into the intact external anal sphincter using an electromyographic guidance. The animals received 1.5 or 4.5 × 10 cells of GFP-labeled myoblasts, dividing the dose between three injection sites. The remaining in vitro myoblasts were still viable 28 days post-harvest. Ten days after transplantation the anal sphincter complex was surgically extracted. RESULTS : The presence of GFP-labeled myoblasts was confirmed within the external anal sphincter. CONCLUSIONS : This demonstrates that myoblasts can be successfully extracted, cultivated in vitro, transplanted and will integrate into the host tissue.
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Affiliation(s)
- Jocelyn B Craig
- From the *Division of Urogynecology, Department of Obstetrics and Gynecology, and †Department of Anatomy and Neurobiology, Reeve-Irvine Research Center, University of California-Irvine, Orange, CA
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20
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A prospective non-randomized two-centre study of patients with passive faecal incontinence after birth trauma and patients with soiling after anal surgery, treated by elastomer implants versus rectal irrigation. Int J Colorectal Dis 2012; 27:1191-8. [PMID: 22576903 PMCID: PMC3430837 DOI: 10.1007/s00384-012-1468-9] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/13/2012] [Indexed: 02/04/2023]
Abstract
AIM This study is a prospective evaluation of patients with passive faecal incontinence and patients with soiling treated by elastomer implants and rectal irrigation. PATIENTS AND METHODS Patients with passive faecal incontinence after birth trauma resulting from a defect of the internal sphincter and patients with soiling after previous anal surgery were included. All patients underwent endo-anal ultrasound, magnetic resonance imaging, and anal manometry. The patients with passive faecal incontinence were initially treated by anal sphincter exercises and biofeedback therapy during half a year. The patients completed incontinence scores, a quality of life questionnaire, and a 2-week diary card. RESULTS The elastomer group consisted of 30 males and 45 females with a mean age of 53 years (25-77). The rectal irrigation group consisted of 32 males and 43 females with a mean age of 50 years (25-74). At 6 months follow-up, 30 patients with soiling of the rectal irrigation group and only nine patients of the elastomer group were completely cured (p = 0.02). Only three patients with passive faecal incontinence were cured in the rectal irrigation group and none in the elastomer group. Three distal migrations of elastomer implants required removal at follow-up. CONCLUSIONS After patients had performed anal sphincter exercises, no clear improvement of passive faecal incontinence was obtained by elastomer implants or rectal irrigation. However, rectal irrigation is far more effective than elastomer implants in patients with soiling.
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Ratto C, Parello A, Donisi L, Litta F, De Simone V, Spazzafumo L, Giordano P. Novel bulking agent for faecal incontinence. Br J Surg 2011; 98:1644-52. [PMID: 21928378 PMCID: PMC3229845 DOI: 10.1002/bjs.7699] [Citation(s) in RCA: 42] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/04/2011] [Indexed: 12/13/2022]
Abstract
BACKGROUND Various injectable bulking agents have been used for the treatment of faecal incontinence (FI). However, encouraging early results are not maintained over time. This study aimed to assess short- and medium-term results of a new bulking agent for the treatment of FI. METHODS The Gatekeeper(™) prosthesis comprises a thin solid polyacrylonitrile cylinder that becomes thicker, shorter and softer within 24 h after implantation. Fourteen patients with FI underwent treatment with Gatekeeper(™) under local anaesthesia. Four prostheses were implanted in the intersphincteric space in each patient, under endoanal ultrasound guidance. Number of episodes of major FI, Cleveland Clinic FI score (CCFIS), Vaizey score, anorectal manometry, endoanal ultrasonography (EUS), health status and quality of life (Short Form 36 and Faecal Incontinence Quality of Life questionnaires) were assessed before and after treatment. RESULTS Mean(s.d.) follow-up was 33·5(12·4) months. There were no complications. There was a significant decrease in major FI episodes from 7·1(7·4) per week at baseline to 1·4(4·0), 1·0(3·2) and 0·4(0·6) per week respectively at 1-month, 3-month and last follow-up (P = 0·002). CCFIS improved significantly from 12·7(3·3) to 4·1(3·0), 3·9(2·6) and 5·1(3·0) respectively (P < 0·001), and Vaizey score from 15·4(3·3) to 7·1(3·9), 4·7(3·0) and 6·9(5·0) respectively (P = 0·010). Soiling and ability to postpone defaecation improved significantly, and patients reported significant improvement in health status and quality of life. At follow-up, manometric parameters had not changed and EUS did not demonstrate any prosthesis dislocation. CONCLUSION The Gatekeeper(™) anal implant seemed safe, reliable and effective. Initial clinical improvement was maintained over time, and follow-up data were encouraging.
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Affiliation(s)
- C Ratto
- Department of Surgical Sciences, Catholic University, Rome, Italy.
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22
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Hollingshead JRF, Dudding TC, Vaizey CJ. Sacral nerve stimulation for faecal incontinence: results from a single centre over a 10-year period. Colorectal Dis 2011; 13:1030-4. [PMID: 20718837 DOI: 10.1111/j.1463-1318.2010.02383.x] [Citation(s) in RCA: 54] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
AIM Sacral nerve stimulation (SNS) is considered a first-line surgical treatment option for faecal incontinence. There is little information on long-term results. The results of SNS for faecal incontinence performed at a single centre over a 10-year period are reported. METHOD A cohort analysis of consecutive patients treated with SNS for faecal incontinence over a 10-year period was carried out. Data were collected prospectively using bowel habit diaries and St Mark's and Cleveland Clinic incontinence scores. Treatment success was defined as a >50% reduction in episodes of faecal incontinence compared with baseline. RESULTS Temporary SNS was performed in 118 patients, and 91 (77%) were considered suitable for chronic stimulation. The median period of follow up was 22 (1-138) months. Seventy patients were followed for 1 year with success in 63 (90%). Of 18 patients followed for 5 years, 15 (83%) reported continued success, 11 (61%) maintained full efficacy, 4 (22%) reported some loss, and 3 (17%) reported complete loss. Three patients with a 10-year follow up had no loss in efficacy. Overall, complete loss of efficacy was observed in 14 (16%) patients at a median of 11.5 months following implantation. A further 5 (6%) patients showed deterioration with time. In 9 (47%), no reason for the deterioration in symptoms could be identified. CONCLUSIONS SNS can be effective for up to 10 years. Some patients experience deterioration in symptoms over time. The reasons for this are often not evident.
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Hussain ZI, Lim M, Stojkovic SG. Systematic review of perianal implants in the treatment of faecal incontinence. Br J Surg 2011; 98:1526-36. [PMID: 21964680 DOI: 10.1002/bjs.7645] [Citation(s) in RCA: 37] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/02/2011] [Indexed: 02/02/2023]
Abstract
BACKGROUND Injectable bulking agents have been used with varying success for the treatment of faecal incontinence. This systematic review aimed to investigate the various injectable agents and techniques used for the treatment of faecal incontinence, and to assess their safety and efficacy. METHODS Thirty-nine publications were identified and studied. The following variables were pooled for univariable analysis: type, location, route of bulking agents, and the use of ultrasound guidance, antibiotics, laxatives and anaesthetics. Predictors of the development of complications and successful outcomes were identified by multivariable logistic regression analysis. RESULTS A total of 1070 patients were included in the analysis. On multivariable analysis, the only significant predictor of the development of complications was the route of injection of bulking agents (odds ratio 3·40, 95 per cent confidence interval 1·62 to 7·12; P = 0·001). Two variables were significant predictors of a successful short-term outcome: the use of either PTQ(®) (OR 5·93, 2·21 to 16·12; P = 0·001) or Coaptite(®) (OR 10·74, 1·73 to 65·31; P = 0·001) was associated with a greater likelihood of success. Conversely, the use of local anaesthetic was associated with a lower likelihood of success (OR 0·18, 0·05 to 0·59; P = 0·005). Failure to use laxatives in the postoperative period resulted in a poorer medium- to longer-term outcome (OR 0·13, 0·06 to 0·25; P = 0·001). CONCLUSION This systematic review has identified variations in the practice of injection of bulking agents that appear to influence the likelihood of complications and affect the outcomes after treatment.
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Affiliation(s)
- Z I Hussain
- Department of Colorectal Surgery, York Teaching Hospital NHS Foundation Trust, Wigginton Road, York YO26 5QJ, UK.
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Ahmadi R, Mordan N, Forbes A, Day RM. Enhanced attachment, growth and migration of smooth muscle cells on microcarriers produced using thermally induced phase separation. Acta Biomater 2011; 7:1542-9. [PMID: 21187173 DOI: 10.1016/j.actbio.2010.12.022] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2010] [Revised: 12/09/2010] [Accepted: 12/21/2010] [Indexed: 11/19/2022]
Abstract
Microcarriers are widely used for the expansion of cells in vitro, but also offer an approach for combining cell transplantation and tissue bulking for regenerative medicine in a minimally invasive manner. This could be beneficial in conditions associated with muscle damage or atrophy, such as faecal incontinence, where the use of bulking materials or cell transplantation alone has proven to be ineffective. Microcarriers currently available have not been designed for this purpose and are likely to be suboptimal due to their physical and biochemical properties. The aim of this study was to investigate macroporous microspheres of polylactide-co-glycolide (PLGA), prepared using a thermally induced phase separation technique, for their suitability as cell microcarriers for the transplantation of smooth muscle cells. Cell attachment, growth and migration were studied and compared with commercially available porcine gelatin microcarriers (Cultispher-S) in suspension culture. Smooth muscle cells attached more rapidly to the PLGA microcarriers, which also significantly enhanced the rate of cell growth compared with Cultispher-S microcarriers. The majority of smooth muscle cells attached to the PLGA microcarriers in suspension culture were able to migrate away over a 15 day period of static culture, unlike Cultispher-S microcarriers which retained the majority of cells. The ability of PLGA microcarriers to enhance cell growth combined with their capacity to release cells at the sites of delivery are features that make them ideally suited for use as a cell transplantation delivery device in tissue engineering and regenerative medicine.
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Affiliation(s)
- R Ahmadi
- Centre for Gastroenterology and Nutrition, University College London, London, UK
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25
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Mellgren A. Endoanal Ultrasound in the Assessment of Fecal Incontinence. SEMINARS IN COLON AND RECTAL SURGERY 2010. [DOI: 10.1053/j.scrs.2010.09.006] [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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Functional external anal sphincter reconstruction for treatment of anal incontinence using muscle progenitor cell auto grafting. Dis Colon Rectum 2010; 53:1415-21. [PMID: 20847624 DOI: 10.1007/dcr.0b013e3181e53088] [Citation(s) in RCA: 38] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE This study aimed to investigate the feasibility of autologous muscle progenitor cell transplantation for anal sphincter regeneration in a rabbit model of anal incontinence. We examined the serial changes in structure, with particular emphasis on histology and functional properties of the anal sphincter. METHODS External anal sphincterotomy was performed in 21 rabbits; these rabbits were randomly assigned to 2 groups. In group I (n = 9), autologous muscle progenitor cells were isolated from quadriceps myofiber explants, labeled with PKH-26, and injected into sphincter 3 weeks after sphincterotomy. In group II (n = 12), saline buffer was injected at the site of damage. Sphincter electromyography and manometry were performed immediately before sphincterotomy and 14, 28, and 60 days after injection in 3 animals in each group at every interval and the findings were correlated with histomorphological studies. In addition, electromyography and manometry were performed in the remaining 3 rabbits in group II after 6 months. RESULTS In group II, a flaccid sphincter persisted during the 6 months of follow-up. In group I, muscle progenitor autografting accelerated sphincter myofiber repair and improvement in functional capacity of the damaged sphincter. Fluorescently labeled cells were detected in all of the grafted sphincters; regenerated myotubes were detectable at the injection site as evidenced by the presence of desmin. We also observed a significant decrease in interstitial fibrosis in the 4th week and strikingly higher amounts of Ki-67-positive cells in group I. Manometry and electromyography showed a significant improvement in the mean resting anal canal pressure and sphincteric electrical activity 4 weeks after cell injection, respectively. CONCLUSION Transplanting muscle progenitor cells showed the potential for recapitulation of a myogenic program when injected into deficient rabbit anal sphincter. Objective anal measures of resting and stimulated pressures and electromyographic profile improved. Stem cell-mediated anal myoplasty warrants additional investigation as a new method to treat anal incontinence before attempting this modality in the clinical setting.
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Luo C, Samaranayake CB, Plank LD, Bissett IP. Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence. Colorectal Dis 2010; 12:296-303. [PMID: 19320664 DOI: 10.1111/j.1463-1318.2009.01828.x] [Citation(s) in RCA: 29] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
Abstract
OBJECTIVE The aim of this study was to systematically review all published evidence to determine the efficacy and safety of injectable bulking agents for passive faecal incontinence (FI) in adults. METHOD Electronic searches were performed for MEDLINE, EMBASE, ISI Web of Knowledge and other relevant databases. Hand searching of relevant conference proceedings was undertaken. Studies were considered if they met the predefined inclusion criteria of more than ten adult patients and receiving an injectable bulking agent for passive FI with a validated means of assessing preoperative and postoperative incontinence. RESULTS Thirteen case series studies and one randomized placebo-controlled trial (RCT) were included with a total of 420 patients. Two completed RCTs with placebo control were identified but results were unobtainable. Coaptite, Contigen, Durasphere, EVOH and PTQ injections were assessed with 24, 73, 83, 21 and 208 patients respectively. Most studies reported a statistically significant improvement in incontinence scores and quality of life. No statistically significant difference was found between the treatment and placebo arms in the RCT. No serious adverse events were reported. CONCLUSIONS Currently there is little evidence for the effectiveness of injectable bulking agents in managing passive FI. The inability to obtain results from two further RCTs concerned the reviewers and hindered their ability to make strong recommendations. The identified injectable bulking agents appear to be safe with only minor complications reported.
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Affiliation(s)
- C Luo
- Department of Surgery, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand
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Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg 2010; 251:441-9. [PMID: 20160636 DOI: 10.1097/sla.0b013e3181cf8ed0] [Citation(s) in RCA: 227] [Impact Index Per Article: 15.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. METHODS Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing > or =50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that > or =50% of subjects would achieve therapeutic success, defined as > or =50% reduction of incontinent episodes per week at 12 months compared with baseline. RESULTS A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2-69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%-90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. CONCLUSION Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.
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Abstract
Abstract
Background
In North Queensland demand for conservative faecal incontinence treatments outweighs supply. Injectable bulking agents offer a safe and effective treatment for patients with internal anal sphincter (IAS) dysfunction.
Methods
Information, including age and sex, baseline incontinence score, quality of life, resting and squeeze pressures, was collected for 74 patients (37 men) who received intersphincteric PTQ™ injections. Postimplant satisfaction was assessed at 6-week review. Incontinence scores and satisfaction ratings were determined annually.
Results
At a median follow-up of 28 months, 52 patients (70 per cent) with IAS dysfunction who received PTQ™ anal implants as a treatment for faecal incontinence were continent and extremely satisfied with the result. The incontinence score in participants who remained incontinent was reduced significantly from 12 of 20 before implant to 3·5 of 20 at follow-up (P < 0·001). Migration rates improved with experience. The poorest results occurred in women with pudendal neuropathy, or patients who had previously received biofeedback treatment.
Conclusion
Implanted PTQ™ provides an effective solution to faecal incontinence in the short and mid term for patients with IAS dysfunction.
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Affiliation(s)
- L Bartlett
- School of Public Health, Tropical Medicine and Rehabilitation Science, James Cook University, Townsville, Queensland, Australia
| | - Y-H Ho
- School of Medicine and the Australian Institute of Tropical Medicine within the North Queensland Centre for Cancer Research, James Cook University, Townsville, Queensland, Australia
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Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum 2009; 52:1101-6. [PMID: 19581853 DOI: 10.1007/dcr.0b013e31819f5cbf] [Citation(s) in RCA: 43] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
Abstract
PURPOSE NASHA Dx gel has been used extensively for treatments in the field of urology. This study was performed to evaluate NASHA Dx gel as an injectable anal canal implant for the treatment of fecal incontinence. METHODS Thirty-four patients (5 males, 29 females; median age, 61 years; range, 34 to 80) were injected with 4 x 1 ml of NASHA Dx gel, just above the dentate line in the submucosal layer. The primary end point was change in the number of incontinence episodes and a treatment response was defined as a 50 percent reduction compared with pretreatment. All patients were followed up at 3, 6, and 12 months. RESULTS The median number of incontinence episodes during four weeks was 22 (range, 2 to 77) before treatment, at 6 months it was 9 (range, 0 to 46), and at 12 months it was 10 (range, 0 to 70, P = 0.004). Fifteen patients (44 percent) were responders at 6 months, compared with 19 (56 percent) at 12 months. No long-term side effects or serious adverse events were reported. CONCLUSIONS Submucosal injection of NASHA Dx gel is an effective treatment for fecal incontinence. The effect is sustained for at least 12 months. The treatment is associated with low morbidity.
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Affiliation(s)
- Johan Danielson
- Department of Surgery, Akademiska Sjukhuset, Uppsala, Sweden.
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31
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Gladman MA, Knowles CH. Surgical treatment of patients with constipation and fecal incontinence. Gastroenterol Clin North Am 2008; 37:605-25, viii. [PMID: 18793999 DOI: 10.1016/j.gtc.2008.06.009] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
Patients with constipation and fecal incontinence usually come to the attention of the surgeon when conservative measures have failed to alleviate sufficiently severe symptoms. Following detailed clinical and physiologic assessment, the surgeon should tailor the procedure to specific underlying physiologic abnormalities to restore function. This article describes the rationale, indications (including patient selection), results, and current position controversies of surgical procedures for constipation and fecal incontinence, dividing these into those regarded as historical, contemporary, or evolving. Reported surgical outcome data must be interpreted with caution because for most studies the evidence is of low quality, making comparison of different procedures problematic and emphasizing the need for better designed and conducted clinical trials.
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Affiliation(s)
- Marc A Gladman
- Centre for Academic Surgery, Institute of Cell and Molecular Science, Barts, London, UK
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32
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Abstract
Fecal incontinence (FI) has a significant social and economic impact on the patient and the community. In women, obstetric injury is commonly associated with the development of FI. Understanding FI is aided by a good knowledge of the pelvic floor anatomy and continence mechanisms. This same knowledge along with a good history and physical can guide the physician in selecting appropriate studies and treatment options. Surgical treatment of FI is currently the best option when a sphincter defect exists. The long-term prognosis of the repair is disappointing, however. Ongoing investigations continue in the hopes of getting closer to a cure and to reclaiming the patient's former quality of life.
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33
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Ganio E, Marino F, Giani I, Luc AR, Clerico G, Novelli E, Trompetto M. Injectable synthetic calcium hydroxylapatite ceramic microspheres (Coaptite) for passive fecal incontinence. Tech Coloproctol 2008; 12:99-102. [DOI: 10.1007/s10151-008-0406-x] [Citation(s) in RCA: 29] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/19/2007] [Accepted: 04/03/2008] [Indexed: 11/30/2022]
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34
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Mion F, Roman S, Barth X, Damon H. [What's new in the treatment of fecal incontinence?]. GASTROENTEROLOGIE CLINIQUE ET BIOLOGIQUE 2008; 32:S240-S245. [PMID: 18462900 DOI: 10.1016/j.gcb.2008.04.017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/26/2023]
Affiliation(s)
- F Mion
- Hospices civils de Lyon, exploration fonctionnelle digestive, hôpital Edouard-Herriot, 5, place d'Arsonval, 69374 Lyon cedex 03, France.
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35
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Bols EMJ, Berghmans BCM, Hendriks EJM, Baeten CGMI, de Bie RA. Physiotherapy and surgery in fecal incontinence: an overview. PHYSICAL THERAPY REVIEWS 2008. [DOI: 10.1179/174328808x252073] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
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36
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Altomare DF, La Torre F, Rinaldi M, Binda GA, Pescatori M. Carbon-coated microbeads anal injection in outpatient treatment of minor fecal incontinence. Dis Colon Rectum 2008; 51:432-5. [PMID: 18204878 DOI: 10.1007/s10350-007-9170-7] [Citation(s) in RCA: 56] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2007] [Revised: 08/16/2007] [Accepted: 09/02/2007] [Indexed: 12/16/2022]
Abstract
PURPOSE Anal bulking agents are injected to pose a stronger obstacle to the involuntary passage of feces and gas. This prospective, multicenter study was designed to evaluate the safety and efficacy of Durasphere anal injection for the treatment of fecal incontinence. PATIENTS AND METHODS Thirty-three unselected patients with incontinence (24 females; mean age, 61.5 +/- 14 (range, 22-83) years) underwent anal bulking agent submucosal injection with carbon-coated microbeads (Durasphere) in the outpatient regimen. The causes of incontinence were obstetric lesions in 18.2 percent, iatrogenic in 36.4 percent, rectal surgery in 12.1 percent, and idiopathic in 33.3 percent. Previous unsuccessful treatments for fecal incontinence included diet and drugs in 16 patients, biofeedback training in 7 patients, sacral nerve modulation in 6 patients, sphincteroplasty in 2 patients, artificial bowel sphincter in 1 patient, and PTQ macroplastique bulking agent in 1 patient. Under local anesthesia and antibiotic prophylaxis, a mean of 8.8 (range, 2-19) ml of Durasphere were injected into the submucosa by using a 1.5-inch, angled, 18-gauge needle. RESULTS After a median follow-up of 20.8 (range, 10-22) months, the median Cleveland Clinic continence score decreased significantly from 12 to 8 (P < 0.001) and the median American Medical System score from 89 to 73 (P = 0.0074), but the Fecal Incontinence Quality of Life did not change significantly (74 to 76, P = not significant). Anal manometry significantly improved (resting pressure increasing from 34 to 42 mmHg; P = 0.008) and squeezing pressure from 66 to 79 mmHg (P = 0.04). Two patients complained of moderate anal pain for a few days after the implant, one patient had asymptomatic leakage of the injected material through a mucosa perforation, and two had distal migration of the Durasphere along the dentate line. CONCLUSIONS Anal bulking agent injection is a safe treatment and can mitigate the severity of fecal incontinence by increasing anal pressure but does not significantly improve the quality of life.
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Affiliation(s)
- D F Altomare
- Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
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37
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de la Portilla F, Fernández A, León E, Rada R, Cisneros N, Maldonado VH, Vega J, Espinosa E. Evaluation of the use of PTQ implants for the treatment of incontinent patients due to internal anal sphincter dysfunction. Colorectal Dis 2008; 10:89-94. [PMID: 17608753 DOI: 10.1111/j.1463-1318.2007.01276.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
OBJECTIVE This study reports the results of injectable silicone PTQ implants for faecal incontinence due to internal anal sphincter (IAS) dysfunction. METHOD Twenty patients (12 women) with partial faecal incontinence aged from 55 to 65 years were treated by a PTQ implant. All patients completed the Cleveland Clinic Continence and Quality of Life questionnaire. Endoluminal ultrasound and anorectal physiological testing were performed in each patient. All implants were inserted into the submucosal plane without ultrasound guidance. RESULTS Faecal continence was significantly improved up to 1 year. The Wexner continence score fell from a median of 13.05 (range, 5-20) before treatment to 4.5 (range 2-7.7) at 1 month after (P < 0.005). This rose gradually to 6.2 (range, 0-16) at one year (P = 0.02) and 9.4 (range, 1-20) at 2 years (P = 0.127). There were no differences in resting or squeeze pressure before and at 3 months after treatment (P = 0.86 and P = 0.93). Fourteen (70%) patients experienced pruritus ani during the first few weeks after the procedure and one developed infection at the implant site. CONCLUSION Silicone implantation is minimally invasive and technically simple. It is effective over 1 year in the treatment of faecal incontinence due to IAS dysfunction.
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Affiliation(s)
- F de la Portilla
- Coloproctology Unit, Department of General Surgery, Hospital Juan Ramón Jiménez, Huelva, Spain
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38
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Abstract
BACKGROUND Fecal incontinence is common and can be socially debilitating. Nonoperative management of fecal incontinence includes dietary modification, antidiarrheal medication, and biofeedback. The traditional surgical approach is sphincteroplasty if there is a defect of the external sphincter. Innovative treatment modalities have included sacral nerve stimulation, injectable implants, dynamic graciloplasty, and artificial bowel sphincter. DISCUSSION This review was designed to assess the various surgical options available for fecal incontinence and critically evaluate the evidence behind these procedures. The algorithm in the surgical treatment of fecal incontinence is shifting. Injectable therapy and sacral nerve stimulation are likely to be the mainstay in future treatment of moderate and severe fecal incontinence, respectively. Sphincteroplasty is limited to a small group of patients with isolated defect of the external sphincter. A stoma, although effective, can be avoided in most cases.
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Affiliation(s)
- Jane J Y Tan
- Department of Colorectal Surgery, Royal Melbourne Hospital, Melbourne, Australia.
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39
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Abstract
Anorectal motor disorders such as faecal incontinence, chronic anorectal pain and solitary rectal ulcer syndrome are common in the community. They cause psychological distress, affect quality of life, and pose a significant economic burden. In recent years, many strides have been made in the diagnostic criteria and in the mechanistic understanding of anorectal disorders. The use of innovative manometric, neurophysiological and radiological techniques have shed new light on the underlying pathophysiology. Also, it has been recognised that psychological dysfunction play an important role. However, there is a lack of consensus regarding what is abnormal, regarding the overlap between phenotypes and regarding optimal diagnostic approaches or tests. There has been little advance in drug therapy for these conditions. Although several treatments have been tried and appear promising, controlled trials are either lacking or have provided insignificant evidence. There is a need for improved medical, behavioural and surgical treatments for these conditions.
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Affiliation(s)
- Jose M Remes-Troche
- Section of Neurogastroenterology, Division of Gastroenterology-Hepatology, Department of Internal Medicine University of Iowa Carver College of Medicine & Clinical Research Center, Iowa City, IA 52242, USA
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40
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Siproudhis L, Morcet J, Lainé F. Elastomer implants in faecal incontinence: a blind, randomized placebo-controlled study. Aliment Pharmacol Ther 2007; 25:1125-32. [PMID: 17439514 DOI: 10.1111/j.1365-2036.2007.03293.x] [Citation(s) in RCA: 45] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
AIM To test efficacy and safety of polydimethylsiloxane elastomer implants, a silicone biomaterial, in patients with severe faecal incontinence related to an impaired internal anal sphincter. METHODS Subjects were randomized to receive three injections of 2.5 mL of either physiological saline or polydimethylsiloxane elastomer. After local anaesthesia, an 18 gauge, 2.5-in needle was inserted through the perianal skin and laid down into the intersphincteric space. Treatment (saline or polydimethylsiloxane elastomer) was administered by means of a ratchet gun. Three injections of 2.5 mL each were performed in the area of the internal anal sphincter at 3, 7 and 11 o'clock positions. Main end point was the percentage of subjects in each treatment arm experiencing a successful treatment, defined as a Cleveland Clinic Florida-Faecal Incontinence score <8, 3 months after treatment. Secondary end points were quality of life scores, weekly number of faecal incontinence episodes, subject acceptance and adverse events rate. Both patients and end point assessments were blinded to treatment. RESULTS 44 women (64.3 +/- 9 years) with a baseline Cleveland Clinic Florida-Faecal Incontinence score > or =8 were enrolled prospectively; 22 received polydimethylsiloxane elastomer and 22 saline treatment. Treatment was well tolerated. At 3 months, the percentage of subjects experiencing a successful treatment was not different between polydimethylsiloxane elastomer and saline groups (23% vs. 27%, respectively, P = 0.73). Moreover, Cleveland Clinic Florida-Faecal Incontinence score was not significantly different between polydimethylsiloxane elastomer and saline groups (11.7 +/- 4.7 vs. 11.4 +/- 4.5, respectively, P = 0.79). CONCLUSIONS Polydimethylsiloxane elastomer implants cannot be recommended for treatment of severe faecal incontinence related to impaired internal anal sphincter.
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Affiliation(s)
- L Siproudhis
- Service des Maladies de l'Appareil Digestif, CHU Pontchaillou, Rennes, France.
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41
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Abstract
Fecal incontinence is a common clinical problem that often is frustrating to the patient and treating physician. Nonsurgical management for fecal incontinence includes dietary manipulation, Kegel exercises, perianal skin care, and biofeedback therapy. Pharmacotherapies often are used to assist in management of fecal incontinence. A variety of pharmacotherapies have been utilized for the management of fecal incontinence; limited data from randomized, placebo-controlled trials are available. This is a review of the existing literature on clinical trials of several classes of drugs and other medical therapies that may be beneficial for patients with fecal incontinence. The information in this article was obtained by a MEDLINE search for all clinical trials of drug therapy for fecal incontinence. These treatments and the existing data on their use are summarized. Treatments reviewed include stool bulking agents, with an emphasis on the most promising effect obtained with calcium polycarbophil, constipating agents, including loperamide, codeine, amitriptyline, atropine, and diphenoxylate agents injected into the anal sphincter, drugs to enhance anal sphincter function, including topical phenylepherine and oral sodium valproate, and trials of fecal disimpaction. A new classification to easily remember the treatment categories for this condition, based on the "ABCs of treatment for fecal incontinence," has been introduced into the structure of this review.
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Affiliation(s)
- Eli D Ehrenpreis
- Division of Gastroenterology, Rush Medical Center, Chicago, Illinois, USA.
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42
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Abstract
BACKGROUND Faecal incontinence is a life style-limiting condition with multiple aetiologies. Surgical cure is not often possible. METHODS AND RESULTS A review of the literature was undertaken using Medline, Cochrane database and standard textbooks. Advanced imaging techniques now inform the treatment algorithm and objectively assess success. The long-term outcome of anal surgery is uncertain. Modern approaches favour conservative measures, such as biofeedback, and less invasive surgical procedures. Stoma formation is a definitive option for some patients. CONCLUSION Current treatment of faecal incontinence is evolving from a sphincter-focused view to a more holistic one, recognizing the influence of the pelvic floor and psyche in maintaining continence. Modern imaging modalities direct treatment strategies.
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Affiliation(s)
- D R Chatoor
- Physiology Unit, University College Hospital, 235 Euston Road, London NW1 2BU, UK
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43
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van der Hagen SJ, van Gemert WG, Baeten CG. PTQ™ Implants in the treatment of faecal soiling. Br J Surg 2007; 94:222-3. [PMID: 17205492 DOI: 10.1002/bjs.5463] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022]
Abstract
Effective in the short term
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Affiliation(s)
- S J van der Hagen
- Department of Surgery, University Hospital of Maastricht, Maastricht, The Netherlands.
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44
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Stojkovic SG, Lim M, Burke D, Finan PJ, Sagar PM. Intra-anal collagen injection for the treatment of faecal incontinence. Br J Surg 2006; 93:1514-8. [PMID: 17048278 DOI: 10.1002/bjs.5394] [Citation(s) in RCA: 37] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
Abstract
Abstract
Background
Intra-anal injectable agents have been used to treat faecal incontinence. The aim of this study was to report the experience of a cohort of patients who underwent intra-anal injection of collagen and to determine which patients benefited from the technique.
Methods
Data, including age, sex, incontinence score, classification of incontinence, baseline resting pressure and vector volume, were collected prospectively for 73 consecutive patients (59 women) undergoing intra-anal collagen injection. Patients were reviewed after treatment and incontinence scores documented. A proportion of patients also underwent repeat anorectal physiological testing 8 weeks after the procedure.
Results
At a median follow-up of 12 months after the intra-anal injection, 63 per cent of patients had an improved incontinence score and 73 per cent reported an overall improvement in symptoms. Logistic regression showed that older age and idiopathic faecal incontinence were predictors of a successful outcome (P = 0·042 and P = 0·048 respectively).
Conclusion
Intra-anal collagen injection appears to have a role in the treatment of faecal incontinence. The majority of patients can expect both objective and subjective improvement. The best results are achieved in older patients and in those with idiopathic incontinence.
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Affiliation(s)
- S G Stojkovic
- Department of Colorectal Surgery, Leeds General Infirmary, Leeds, UK
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45
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Abstract
Chronic constipation and fecal incontinence affect 20% of the population and are more prevalent in women, the elderly, those of lower socioeconomic status, and nursing home residents. These disorders pose a significant economic burden and affect quality of life. During the past decade, significant strides have been made in the understanding and treatment of defecation disorders, which have led to real advances in the management of these disorders. These treatments include biofeedback therapy, tegaserod, and lubiprostone for chronic constipation.
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Affiliation(s)
- Jose M Remes-Troche
- GI Division, The University of Iowa Hospital & Clinics, Iowa City, IA 52242, USA
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46
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Maslekar S, Gardiner A, Maklin C, Duthie GS. Investigation and treatment of faecal incontinence. Postgrad Med J 2006; 82:363-71. [PMID: 16754704 PMCID: PMC2563743 DOI: 10.1136/pgmj.2005.044099] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2005] [Accepted: 02/07/2006] [Indexed: 12/17/2022]
Abstract
Faecal incontinence is a debilitating condition affecting people of all ages, and significantly impairs quality of life. Proper clinical assessment followed by conservative medical therapy leads to improvement in more than 50% of cases, including patients with severe symptoms. Patients with advanced incontinence or those resistant to initial treatment should be evaluated by anorectal physiology testing to establish the severity and type of incontinence. Several treatment options with promising results exist. Patients with gross sphincter defects should undergo surgical repair. Those who fail to respond to sphincteroplasty and those with no anatomical defects have the option of either sacral nerve stimulation or other advanced procedures. Stoma formation should be reserved for patients who do not respond to any of the above procedures.
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Affiliation(s)
- S Maslekar
- University of Hull, Academic Surgical Unit, Castle Hill Hospital, Cottingham, UK
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47
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Abstract
Obstructed defecation (OD) and fecal incontinence (FI) are challenging clinical problems, which are commonly encountered in the practice of colorectal surgeons and gastroenterologists. These disorders socially and psychologically distress patients and greatly impair their quality of life. The underlying anatomical and pathophysiological changes are complex, often incompletely understood and cannot always be determined. As a consequence, many medical, surgical, and behavioral approaches have been described, with no panacea. Over the past decade, advances in an understanding of these disorders together with rational and similar methods of evaluation in anorectal physiology laboratories (ARP), radiology studies, and new surgical techniques have led to promising results. In this brief review, we discuss treatment strategies and recent updates on clinical and therapeutic aspects of obstructed defecation and fecal incontinence.
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Affiliation(s)
- Marat Khaikin
- Department of Colorectal Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd. Weston, FL 33331, USA
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