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Lo TS, Harun F, Chua S, Jhang LS, Hsieh WC, Lin YH. Single incision mini sling for the treatment of urodynamic stress incontinence: Surgical outcomes and preoperative predictors of failure. Taiwan J Obstet Gynecol 2024; 63:685-691. [PMID: 39266149 DOI: 10.1016/j.tjog.2024.03.020] [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] [Accepted: 03/19/2024] [Indexed: 09/14/2024] Open
Abstract
OBJECTIVE To evaluate the surgical outcomes and predictors of failure of Single Incision Mini Sling (Ophira) in women with urodynamic stress incontinence. MATERIALS AND METHODS Records of 115 women underwent anti-incontinence procedure using Ophira Mini Sling from June 2019 to September 2020 reviewed. Subjective evaluation was assessed using validated IIQ-7, UDI-6, POPDI-6 and PISQ-12 questionnaires. Multichannel urodynamics, 1-h pad test and 72-h voiding diary was performed as objective evaluation. Primary outcome was the objective cure rate of negative urine leak on provocative filling cystometry and 1-h pad test weight <2 g, and subjective cure rate was negative response to question 3 of UDI-6. Secondary outcome was to identify risk factors associated with failure for Ophira. RESULTS Total of 108 women were evaluated. The objective cure rate was 91.7% with subjective cure rate of 86.1%. Comparison of clinical outcome shows significant improvement of USI post-operatively (p < 0.001) and reflected in 1-h pad test (p < 0.001). Improvement in all subjective evaluation parameters is seen except for POPDI-6. Failure of Ophira correlate significantly in women age >66 years, presence of asthma, pre-operative Intrinsic Sphincter Deficiency (ISD), and Maximum Urethral Closure Pressure (MUCP) value < 40 cmH20. CONCLUSION Ophira Single Incision Mini Sling is safe and effective treatment option for USI, showing high objective and subjective cure rates with low incidence of complications. Non-modifiable risks of age ≥66 years, asthma status, pre-operative intrinsic sphincteric deficiency and low maximal urethral closure pressure were the factors of failure for Ophira.
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Affiliation(s)
- Tsia-Shu Lo
- Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung Medical Center, Keelung, Taiwan; Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Taipei, Medical Center, Taipei, Taiwan; Chang Gung University, School of Medicine, Taoyuan, Taiwan.
| | - Fazlin Harun
- Department of Obstetrics and Gynecology, Women and Children Hospital (Hospital Tunku Azizah), Kuala Lumpur, Malaysia
| | - Sandy Chua
- Department of Obstetrics and Gynecology, Cebu Institute of Medicine-Cebu Velez General Hospital, Cebu City, Philippines
| | - Lan-Sin Jhang
- Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Tucheng Medical Center, Keelung, Taiwan
| | - Wu-Chiao Hsieh
- Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Chang Gung University, School of Medicine, Taoyuan, Taiwan
| | - Yi-Hao Lin
- Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Chang Gung University, School of Medicine, Taoyuan, Taiwan
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Qatawneh A, Thekrallah F, Alaqqad HM, AlTayyar MA, Ahmed RF, Ashour TO. Single Incision Sling Surgery for Female Stress Urinary Incontinence: A Retrospective Cohort Single-Institution Study. J Clin Med 2024; 13:4908. [PMID: 39201050 PMCID: PMC11355131 DOI: 10.3390/jcm13164908] [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: 07/08/2024] [Revised: 08/07/2024] [Accepted: 08/14/2024] [Indexed: 09/02/2024] Open
Abstract
Background: Stress urinary incontinence (SUI) affects around 35% of adult women and has a significant impact on quality of life. A single incision sling (SIS), such as Altis®, was introduced to improve original slings and avoid complications. The present study aimed to evaluate the SIS Altis® subjective and objective cure rates of women with SUI, mixed urinary incontinence (MUI), recurrent SUI, and SUI with concomitant prolapse and report its complications from one single medical center. Methodology: A retrospective cohort, unsponsored study was conducted at the Jordan University Hospital. All women patients were treated with the SIS Altis® procedure, and prolapse procedures were also completed as necessary. The chi square analysis for the cure rates was conducted between the subgroups. Results: From June 2016 to June 2019, 111 women patients with a mean age of 48.0 ± 11.3 years underwent a SIS Altis® procedure. The overall outcome resulted in 81% and 85% of patients being subjectively and objectively cured. The subjectively cured MUI patients were significantly fewer than SUI patients (70% versus 86%, p < 0.05), and patients with recurrent SUI had significantly lower rates (56% for subjective and objective cure rates; p < 0.01 and 0.001). Of the 44 patients who underwent SIS Altis® and concomitant vaginal repair surgery, no significant differences in subjective and objective cure rates were observed. Only 2.7% of women had mild pain, 2.7% had vaginal tape erosion, and 9% had to be re-operated on. Conclusions: The Altis® procedure is effective in women who suffer from SUI for a 19-month follow-up period. However, recurrent SUI patients had lower subjective and objective cure rates than primary SUI patients. Further research is needed with a larger sample size in a prospective study design to determine the effectiveness of single SIS in patients with recurrent SUI.
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Affiliation(s)
- Ayman Qatawneh
- Department of Gynecology and Obstetrics, School of Medicine, The University of Jordan, Amman 11942, Jordan;
| | - Fidaa Thekrallah
- Department of Gynecology and Obstetrics, School of Medicine, The University of Jordan, Amman 11942, Jordan;
| | - Huda M. Alaqqad
- School of Medicine, The University of Jordan, Amman 11942, Jordan; (H.M.A.); (M.A.A.); (R.F.A.); (T.O.A.)
| | - Maysa A. AlTayyar
- School of Medicine, The University of Jordan, Amman 11942, Jordan; (H.M.A.); (M.A.A.); (R.F.A.); (T.O.A.)
| | - Reem F. Ahmed
- School of Medicine, The University of Jordan, Amman 11942, Jordan; (H.M.A.); (M.A.A.); (R.F.A.); (T.O.A.)
| | - Tala O. Ashour
- School of Medicine, The University of Jordan, Amman 11942, Jordan; (H.M.A.); (M.A.A.); (R.F.A.); (T.O.A.)
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Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2023; 10:CD008709. [PMID: 37888839 PMCID: PMC10604512 DOI: 10.1002/14651858.cd008709.pub4] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/28/2023]
Abstract
BACKGROUND Stress urinary incontinence imposes a significant health and economic burden on individuals and society. Single-incision slings are a minimally-invasive treatment option for stress urinary incontinence. They involve passing a short synthetic device through the anterior vaginal wall to support the mid-urethra. The use of polypropylene mesh in urogynaecology, including mid-urethral slings, is restricted in many countries. This is a review update (previous search date 2012). OBJECTIVES To assess the effects of single-incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS We searched the Cochrane Incontinence Specialised Register, which contains trials identified from: CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, and two trials registers. We handsearched journals, conference proceedings, and reference lists of relevant articles to 20 September 2022. SELECTION CRITERIA We included randomised or quasi-randomised controlled trials in women with stress (or stress-predominant mixed) urinary incontinence in which at least one, but not all, trial arms included a single-incision sling. DATA COLLECTION AND ANALYSIS We used standard Cochrane methodological procedures. The primary outcome was subjective cure or improvement of urinary incontinence. MAIN RESULTS We included 62 studies with a total of 8051 women in this review. We did not identify any studies comparing single-incision slings to no treatment, conservative treatment, colposuspension, or laparoscopic procedures. We assessed most studies as being at low or unclear risk of bias, with five studies at high risk of bias for outcome assessment. Sixteen trials used TVT-Secur, a single-incision sling withdrawn from the market in 2013. The primary analysis in this review excludes trials using TVT-Secur. We report separate analyses for these trials, which did not substantially alter the effect estimates. We identified two cost-effectiveness analyses and one cost-minimisation analysis. Single-incision sling versus autologous fascial sling One study (70 women) compared single-incision slings to autologous fascial slings. It is uncertain if single-incision slings have any effect on risk of dyspareunia (painful sex) or mesh exposure, extrusion or erosion compared with autologous fascial slings. Subjective cure or improvement of urinary incontinence at 12 months, patient-reported pain at 24 months or longer, number of women with urinary retention, quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison. Single-incision sling versus retropubic sling Ten studies compared single-incision slings to retropubic slings. There may be little to no difference between single-incision slings and retropubic slings in subjective cure or improvement of incontinence at 12 months (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.07; 2 trials, 297 women; low-certainty evidence). It is uncertain whether single-incision slings increase the risk of mesh exposure, extrusion or erosion compared with retropubic minimally-invasive slings; the wide confidence interval is consistent with both benefit and harm (RR 1.55, 95% CI 0.24 to 9.82; 3 trials, 267 women; low-certainty evidence). It is uncertain whether single-incision slings lead to fewer women having postoperative urinary retention compared with retropubic slings; the wide confidence interval is consistent with possible benefit and harm (RR 0.47, 95% CI 0.12 to 1.84; 2 trials, 209 women; low-certainty evidence). The effect of single-incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (RR 4.19, 95% CI 0.31 to 57.28; 2 trials, 182 women; very low-certainty evidence). One study reported quality of life, but not in a suitable format for analysis. Patient-reported pain at more than 24 months and the number of women with dyspareunia were not reported for this comparison. We downgraded the evidence due to concerns about risks of bias, imprecision and inconsistency. Single-incision sling versus transobturator sling Fifty-one studies compared single-incision slings to transobturator slings. The evidence ranged from high to low certainty. There is no evidence of a difference in subjective cure or improvement of incontinence at 12 months when comparing single-incision slings with transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 trials, 2359 women; high-certainty evidence). Single-incision slings probably have a reduced risk of patient-reported pain at 24 months post-surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 trials, 250 women; moderate-certainty evidence). The effect of single-incision slings on the risk of dyspareunia is uncertain compared with transobturator slings, as the wide confidence interval is consistent with possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 trials, 810 women; moderate-certainty evidence). There are a similar number of mesh exposures, extrusions or erosions with single-incision slings compared with transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 trials, 2378 women; high-certainty evidence). Single-incision slings probably result in similar or reduced cases of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 trials, 2891 women; moderate-certainty evidence). Women with single-incision slings may have lower quality of life at 12 months compared to transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 trials, 698 women; low-certainty evidence). It is unclear whether single-incision slings lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator slings (95% CI consistent with possible benefit and harm; RR 1.42, 95% CI 0.94 to 2.16; 13 trials, 1460 women; low-certainty evidence). We downgraded the evidence due to indirectness, imprecision and risks of bias. AUTHORS' CONCLUSIONS Single-incision sling operations have been extensively researched in randomised controlled trials. They may be as effective as retropubic slings and are as effective as transobturator slings for subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single-incision slings lead to better or worse rates of subjective cure or improvement compared with autologous fascial slings. There are still uncertainties regarding adverse events and longer-term outcomes. Therefore, longer-term data are needed to clarify the safety and long-term effectiveness of single-incision slings compared to other mid-urethral slings.
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Affiliation(s)
- Emily Carter
- The Warrell Unit, St Mary's Hospital, Manchester University NHS Foundation Trust, Manchester, UK
| | - Eugenie E Johnson
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Madeleine Still
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Aalya S Al-Assaf
- National Institute for Health Research (NIHR) Innovation Observatory, Newcastle University, Newcastle Upon Tyne, UK
| | - Andrew Bryant
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Patricia Aluko
- National Institute for Health Research (NIHR) Innovation Observatory, Newcastle University, Newcastle Upon Tyne, UK
| | - Stephen T Jeffery
- Division of Urology, University of Cape Town, Cape Town, South Africa
| | - Arjun Nambiar
- Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK
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Kolek P, Duchonova T, Sedlacek R, Masata J. Could infiltration anesthesia decrease anchor-fixation quality of midurethral slings in the obturator complex? Int Urogynecol J 2023; 34:2381-2387. [PMID: 37133560 DOI: 10.1007/s00192-023-05558-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/09/2023] [Accepted: 04/04/2023] [Indexed: 05/04/2023]
Abstract
INTRODUCTION Single-incision miduretral slings (SIMS) were withdrawn from the market in many countries due to lower efficacy. In some countries they are still in use, preferred primarily because it is possible to perform the procedure under local anesthesia. Based on our previous clinical experience we postulated that local anesthesia decreased primary anchor fixation in the obturator complex. The aim of the study is to assess how local infiltration anesthesia influences anchor fixation of the tape in porcine obturator complex. METHODS The experiment was designed to determine the maximum force necessary to extract an implant anchor from a porcine obturator complex. The implant was extracted at a constant speed and data sampling frequency, and the data on displacement of the testing system, achieved force and time were recorded. The implant arms were divided into groups on the right and left sides. In the first group, the anchored arms were used for two implantations - primary and secondary without infiltration anesthesia - and in the second group they were used in the same way, using infiltration anesthesia. RESULTS A total of 40 implanted anchors were tested in the experiment, totaling ten single-incision slings (each anchor was implanted twice). An average of 8.28 N (Newton) (SD 6.73, min. 2.11, max. 30.34 N) is required to remove the implant anchor from the obturator complex without infiltration by local anesthesia. An average force of 4.40 N (SD 2.99 min. 1.2, max. 9.48) is required to remove the anchor from the obturator complex after infiltration. Local anesthesia reduces anchor fixation in the obturator complex by 47%. CONCLUSIONS The local infiltrative anesthesia decreases anchor fixation in the porcine obturator complex.
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Affiliation(s)
- Petr Kolek
- Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic
- Department of Obstetrics and Gynecology, Thomayer University Hospital in Prague, Prague, Czech Republic
| | - Tereza Duchonova
- Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic
| | - Radek Sedlacek
- Laboratory of Biomechanics, Department of Mechanics, Biomechanics and Mechatronics, Faculty of Mechanical Engineering, Czech Technical University in Prague, Prague, Czech Republic
| | - Jaromir Masata
- Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic.
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Gonzalez RR, Rosamilia A, Eilber K, Kahn BS, White AB, Anger JT. Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent. Int Urogynecol J 2023; 34:2265-2274. [PMID: 37099159 DOI: 10.1007/s00192-023-05538-w] [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: 11/14/2022] [Accepted: 01/13/2023] [Indexed: 04/27/2023]
Abstract
INTRODUCTION AND HYPOTHESIS Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). METHODS This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. RESULTS A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.
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Affiliation(s)
- Ricardo R Gonzalez
- Urology and Female Pelvic Medicine and Reconstructive Surgery, Houston Methodist Hospital, Houston, TX, 77030, USA.
| | - Anna Rosamilia
- Department of Obstetrics and Gynaecology, Monash Medical Centre and Cabrini Hospital, Melbourne, Australia
| | - Karyn Eilber
- Division of Urology, Cedars-Sinai Health System, Los Angeles, CA, USA
| | - Bruce S Kahn
- Department of Obstetrics and Gynecology, Scripps Clinic, San Diego, CA, USA
| | - Amanda B White
- Department of Women's Health, Dell Medical School, University of Texas at Austin, TX, USA, Austin, USA
| | - Jennifer T Anger
- Department of Urology, University of California San Diego Health, San Diego, CA, USA
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Grigoryan B, Shadyan G, Kasyan G, Pushkar D. Adjustable slings versus other surgical methods in female stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J 2023; 34:1351-1367. [PMID: 37067572 DOI: 10.1007/s00192-023-05535-z] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2023] [Accepted: 03/24/2023] [Indexed: 04/18/2023]
Abstract
INTRODUCTION AND HYPOTHESIS The objective of this study was to evaluate the efficacy and safety of different adjustable slings compared to other surgical methods for the treatment of stress urinary incontinence (SUI) among women. METHODS The inclusion criteria were as follows: randomized controlled trials (RCTs) and non-RCTs assessing adult women with SUI. The exclusion criteria were as follows: other types of urinary incontinence, studies that combined conservative interventions and pharmacological treatment, pregnant and lactating patients. Databases were searched up to November 2022 to identify articles evaluating the effectiveness and safety of different adjustable slings compared to other surgical methods for the treatment of SUI among women. The systematic review was conducted in accordance with the PRISMA 2020 checklist and registered in PROSPERO. Risk-of-bias assessment tools recommended by the Cochrane Society were used to evaluate the risk of bias in the included studies. RESULTS Eighteen clinical trials were included in this systematic review, and 11 studies were included in the meta-analysis. Fourteen studies were RCTs, and four were retrospective studies. Only RCTs were included in the meta-analyses. There was no statistically significant difference in the objective cure rate, subjective cure rate, or long-term postoperative complication rate between Ajust single-incision mini-slings (SIMS) and standard mid-urethral slings (SMUS) or MiniArc SIMS. However, the operation time in the adjustable SIMS group was significantly shorter (RR = -4.20, 95% CI: [-7.51, -0.89], p = 0.01). CONCLUSIONS This systematic review and meta-analysis revealed that adjustable SIMS is equally effective when compared with SMUS for the treatment of SUI among women. Moreover, the operation time for the adjustable SIMS was shorter. However, additional well-designed studies with standard outcome measures and complete follow-up periods will help to increase confidence in the choice of different options for treating SUI among women.
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Affiliation(s)
- Bagrat Grigoryan
- Urology Department of Moscow State University of Medicine and Dentistry, Vuchetich 21 str. Moscow, Russian Federation, Moscow, 127206, Russian Federation.
| | - Gor Shadyan
- Department of Urology, Yerevan State Medical University named after M. Heratsi, Yerevan, Armenia
- Urology Department of Izmirlian Medical Center, Yerevan, Armenia
| | - George Kasyan
- Urology Department of Moscow State University of Medicine and Dentistry, Vuchetich 21 str. Moscow, Russian Federation, Moscow, 127206, Russian Federation
- Department of Urology, Yerevan State Medical University named after M. Heratsi, Yerevan, Armenia
| | - Dmitry Pushkar
- Urology Department of Moscow State University of Medicine and Dentistry, Vuchetich 21 str. Moscow, Russian Federation, Moscow, 127206, Russian Federation
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Abdel-Fattah M, Cooper D, Davidson T, Kilonzo M, Boyers D, Bhal K, McDonald A, Wardle J, N'Dow J, MacLennan G, Norrie J. Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT. Health Technol Assess 2022; 26:1-190. [PMID: 36520097 PMCID: PMC9761550 DOI: 10.3310/btsa6148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022] Open
Abstract
BACKGROUND Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings. OBJECTIVE The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness. DESIGN This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). SETTING The trial was set in 21 UK hospitals. PARTICIPANTS Participants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure. INTERVENTIONS Single-incision mini-slings, compared with standard mid-urethral slings. MAIN OUTCOME MEASURES The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function. RESULTS A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; p non-inferiority < 0.001]. Similarly, at 3 years' follow-up, patient-reported success rates in the single-incision mini-sling group were non-inferior to those of the standard mid-urethral sling group at the 10% margin [single-incision mini-sling 72% (177/246) vs. standard mid-urethral sling 67% (157/235), risk difference 5.7, 95% confidence interval -1.3 to 12.8; p non-inferiority < 0.001]. Tape/mesh exposure rates were higher for single-incision mini-sling participants, with 3.3% (9/276) [compared with 1.9% (5/261) in the standard mid-urethral sling group] reporting tape exposure over the 3 years of follow-up. The rate of groin/thigh pain was slightly higher in the single-incision mini-sling group at 15 months [single-incision mini-sling 15% (41/276) vs. standard mid-urethral sling 12% (31/261), risk difference 3.0%, 95% confidence interval -1.1% to 7.1%]; however, by 3 years, the rate of pain was slightly higher among the standard mid-urethral sling participants [single-incision mini-sling 14% (39/276) vs. standard mid-urethral sling 15% (39/261), risk difference -0.8, 95% confidence interval -4.1 to 2.5]. At the 3-year follow-up, quality of life and sexual function outcomes were similar in both groups: for the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life, the mean difference in scores was -1.1 (95% confidence interval -3.1 to 0.8; p = 0.24), and for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised, it was 0 (95% confidence interval -0.1, 0.1; p = 0.92). However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8% (7/145) in the standard mid-urethral sling group, risk difference 7.0%, 95% confidence interval 1.9% to 12.1%]. The base-case economics results showed no difference in costs (-£6, 95% confidence interval -£228 to £208) or quality-adjusted life-years (0.005, 95% confidence interval -0.068 to 0.073) between the groups. There is a 56% probability that single-incision mini-slings will be considered cost-effective at the £20,000 willingness-to-pay threshold value for a quality-adjusted life-year. LIMITATIONS Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness. CONCLUSIONS Single-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years' follow-up. FUTURE WORK Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness. TRIAL REGISTRATION This trial was registered as ISRCTN93264234. FUNDING This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 47. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Mohamed Abdel-Fattah
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | - David Cooper
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Tracey Davidson
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Mary Kilonzo
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Dwayne Boyers
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Kiron Bhal
- Obstetrics and Gynaecology, University Hospital of Wales, Cardiff, UK
| | - Alison McDonald
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | | | - James N'Dow
- Academic Urology Unit, University of Aberdeen, Aberdeen, UK
| | - Graeme MacLennan
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | - John Norrie
- Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
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Abdel-Fattah M, Cooper D, Davidson T, Kilonzo M, Hossain M, Boyers D, Bhal K, Wardle J, N'Dow J, MacLennan G, Norrie J. Single-Incision Mini-Slings for Stress Urinary Incontinence in Women. N Engl J Med 2022; 386:1230-1243. [PMID: 35353961 DOI: 10.1056/nejmoa2111815] [Citation(s) in RCA: 32] [Impact Index Per Article: 10.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
BACKGROUND Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODS We performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTS A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, -1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONS Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up. (Funded by the National Institute for Health Research.).
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Affiliation(s)
- Mohamed Abdel-Fattah
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - David Cooper
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - Tracey Davidson
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - Mary Kilonzo
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - Md Hossain
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - Dwayne Boyers
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - Kiron Bhal
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - Judith Wardle
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - James N'Dow
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - Graeme MacLennan
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
| | - John Norrie
- From the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom
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Kaufmann A. [Therapeutic options in female stress urinary incontinence]. Aktuelle Urol 2021; 52:245-254. [PMID: 33873214 DOI: 10.1055/a-1439-9628] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
Stress urinary incontinence in female patients is characterised by loss of urine without the need to urinate. Causes are manifold and require a good knowledge of the pelvic floor structures and the functionality of the bladder's occlusion system. Before any treatment can be initiated, differentiated diagnostic investigation must uncover the causes in order to be able to show incontinent women the ideal therapeutic options. In addition to conservative treatment strategies, there are several surgical alternatives available that can be used depending on the functional and/or anatomical deficit. Surgical correction produces good results, although a minor rate of possible complications must be accepted.
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Affiliation(s)
- Albert Kaufmann
- Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Mönchengladbach
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10
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Takahashi S, Takei M, Asakura H, Gotoh M, Ishizuka O, Kato K, Koyama M, Takeyama M, Tomoe H, Yamanishi T, Yokoyama O, Yoshida M, Yoshimura Y, Yoshizawa T. Clinical Guidelines for Female Lower Urinary Tract Symptoms (second edition). Int J Urol 2021; 28:474-492. [PMID: 33650242 DOI: 10.1111/iju.14492] [Citation(s) in RCA: 22] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2020] [Accepted: 12/13/2020] [Indexed: 12/13/2022]
Abstract
The present article is an abridged English translation of the Japanese Clinical Guidelines for Female Lower Urinary Tract Symptoms (second edition), published in September 2019. These guidelines consist of a total of 212 pages and are unique worldwide in that they cover female lower urinary tract symptoms other than urinary incontinence. They contain two algorithms for "primary treatment" and "specialized treatment," respectively. These guidelines, consisting of six chapters, address a total of 26 clinical questions including: (i) treatment algorithms; (ii) what are female lower urinary tract symptoms?; (iii) epidemiology and quality of life; (iv) pathology and illness; (v) diagnosis; and (vi) treatment. When the patient's symptoms mainly involve voiding and post-micturition symptoms, specialized treatment should be considered. In the event of voiding symptoms concurrent with storage symptoms, residual urine should be measured; if the residual urine volume is <100 mL, then diagnosis and treatment for storage symptoms is prioritized, and if the volume is ≥100 mL, then specialized treatment should be considered. When storage symptoms are the primary condition, then the patient is subject to the primary treatment algorithm. Specialized treatment for refractory overactive bladder includes botulinum toxin injection and sacral nerve stimulation. For stress urinary incontinence, surgical treatment is indicated, such as urethral slings. The two causes of voiding symptoms and post-micturition symptoms are lower urinary tract obstruction and detrusor underactivity (underactive bladder). Mechanical lower urinary tract obstruction, such as pelvic organ prolapse, is expected to improve with surgery.
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Affiliation(s)
- Satoru Takahashi
- Department of Urology, Nihon University School of Medicine, Tokyo, Japan
| | - Mineo Takei
- Department of Urology, Harasanshin Hospital, Fukuoka, Japan
| | | | - Momokazu Gotoh
- Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Osamu Ishizuka
- Department of Urology, Shinshu University School of Medicine, Matsumoto, Japan
| | - Kumiko Kato
- Department of Female Urology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan
| | - Masayasu Koyama
- Department of Obstetrics and Gynecology, Osaka City University Graduate School of Medicine, Osaka, Japan
| | - Masami Takeyama
- Urogynecology Center, First Towakai Hospital, Takatsuki, Japan
| | - Hikaru Tomoe
- Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan
| | - Tomonori Yamanishi
- Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan
| | - Osamu Yokoyama
- Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan
| | - Masaki Yoshida
- Department of Urology, National Center for Geriatrics and Gerontology, Obu, Japan
| | - Yasukuni Yoshimura
- Female Pelvic Health Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
| | - Tsuyoshi Yoshizawa
- Department of Urology, Nihon University School of Medicine, Tokyo, Japan
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Yıldız G, Batur AF, Akand M, Kılıç Ö, Şahin MO. Comparison of Two Single-Incision Mini-Slings for the Treatment of Incontinence. Med Princ Pract 2020; 30:85-91. [PMID: 32911466 PMCID: PMC7923843 DOI: 10.1159/000511465] [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: 06/09/2020] [Accepted: 09/05/2020] [Indexed: 11/19/2022] Open
Abstract
INTRODUCTION This study aimed to compare the safety and efficacy of 2 single-incision mini-sling (SIMS) systems with different designs of anchoring mechanism. METHODS The records of patients who have been operated for the treatment of female stress urinary incontinence (SUI) with 2 different SIMS systems were retrospectively evaluated. Patient characteristics, physical examination results, and quality of life (QoL) questionnaires were used to evaluate the patients. Primary efficacy endpoints were the cure and failure rates. Secondary efficacy endpoints were complications and differences in QoL questionnaires. RESULTS Eighty-three patients from group 1 (Ophira SIMS system) and 77 patients from group 2 (Gallini SIMS system) were evaluated. There was no significant difference between the 2 groups regarding patient characteristics. The objective cure rates were found to be 83.1 and 79.2% in group 1 and group 2, respectively (p = 0.09). Mesh-related complications, such as anchor displacement, bladder erosion, vaginal erosion, and groin pain, were more common in group 1. No severe complications were observed. For both groups, a significant improvement in all scores of QoL questionnaires was observed after surgery; however, the differences between 2 groups were not significant. CONCLUSIONS The present study showed that the treatment of female SUI with 2 different SIMS systems had similar efficacy, complication rates, and scores in QoL questionnaires.
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Affiliation(s)
- Guner Yıldız
- Urology Clinic, Health Sciences University Dr. Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Izmir, Turkey
| | - Ali Furkan Batur
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey,
| | - Murat Akand
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey
| | - Özcan Kılıç
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey
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Serdinsek T, Martan A, Svabik K, But I, Kolek P, Masata J. Is the fixation of single incision TVT-S tape as good as that of transobturator tape? An ultrasound study of randomized trial results. Int Urogynecol J 2020; 32:141-148. [DOI: 10.1007/s00192-020-04390-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2020] [Accepted: 06/09/2020] [Indexed: 10/24/2022]
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Henry de Villeneuve M, Boualaoui I, El Kharroubi A, Droupy S, Wagner L. [Short-term evaluation of Altis® single-incision sling in women stress urinary incontinence]. Prog Urol 2020; 30:346-352. [PMID: 32370920 DOI: 10.1016/j.purol.2020.03.007] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2019] [Revised: 03/11/2020] [Accepted: 03/12/2020] [Indexed: 10/24/2022]
Abstract
INTRODUCTION Midurethral slings are the main surgical treatment of stress urinary incontinence. Altis is a minimally invasive single-incision sling system. The aim of this study is to report the safety and efficacity results during a year of follow up. MATERIALS AND METHODS This single-centre and retrospective study has been performed in a university hospital, between February 2015 and May 2018. We included women aged more than 18, complaining a stress urinary incontinence with a urethral hypermobility and positive support maneuvers, who had failed from non surgical treatment. A prospective data collection has been done at the moment of inclusion, peroperative time, at 6 weeks, 6 months and a year after the procedure. The main evaluation criteria was the cure rate at twelve months. RESULTS Thirty patients were included in our study. The mean age was 45,4±12,9 years old, the mean ICIQ-UI score was 13,5±4,06 and the median pad test was at 12g. Ninety three percent of the procedures were done as ambulatory surgery. The average operating time was at 22,2minutes. Overall, 75% of our patients were objectively cured and 14,2% were in fail of this treatment. CONCLUSION The short term results show a good efficacity and safety of this procedure. But its place remains to be defined in relation to other techniques, TVT, TOT and non-prosthetic techniques. LEVEL OF EVIDENCE 3.
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Affiliation(s)
- M Henry de Villeneuve
- Service urologie, CHU de Nîmes, 4, rue du Professeur-Robert-Debré, 30029 Nimes, France.
| | - I Boualaoui
- Service urologie, CHU de Nîmes, 4, rue du Professeur-Robert-Debré, 30029 Nimes, France
| | - A El Kharroubi
- Service urologie, CHU de Nîmes, 4, rue du Professeur-Robert-Debré, 30029 Nimes, France
| | - S Droupy
- Service urologie, CHU de Nîmes, 4, rue du Professeur-Robert-Debré, 30029 Nimes, France
| | - L Wagner
- Service urologie, CHU de Nîmes, 4, rue du Professeur-Robert-Debré, 30029 Nimes, France
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14
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Contasure-needleless single incision slings versus transobturator slings (TOT/TVT-O) for female patients with stress urinary incontinence: a systematic review and meta-analysis. BMC Urol 2020; 20:51. [PMID: 32375733 PMCID: PMC7204064 DOI: 10.1186/s12894-020-00622-5] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2019] [Accepted: 04/27/2020] [Indexed: 12/29/2022] Open
Abstract
Background To assess the current evidence on the effectiveness and safety of Contasure-Needleless (C-NDL) versus transobturator slings (TOT/TVT-O) in the management of female stress urinary incontinence (SUI). Methods A comprehensive literature review of articles that investigated the efficacy and safety of C-NDL and TOT/TVT-O was performed based on studies published before June 2019 and retrieved from PubMed, Embase, CNKI and the Cochrane Library. Two reviewers searched the literature, independently extracted the data and evaluated the quality of the data according to the inclusion and exclusion criteria. A meta-analysis was performed by using Review Manager 5.3 software. Results Seven studies with 1188 SUI female patients without intrinsic sphincter deficiency (ISD) or mixed urinary incontinence were included. Our meta-analysis showed that the clinical efficacy of C-NDL is statistically non-inferior to that of TOT / TVT-O in terms of subjective cure rate [OR = 0.77, 95% confidence interval (CI) (0.53 to 1.10), p = 0.15] and objective cure rate [OR = 0.78, 95% CI (0.53 to 1.13), p = 0.19]. In addition, operating times were statistically shorter with C-NDL compared to TOT / TVT-O [mean difference (MD) = − 7.38, 95% CI (− 10.73 to − 4.04), p < 0.0001]. In terms of the postoperative visual analogue scale (VAS) and the incidence of postoperative pain, C-NDL has a greater advantage [MD = − 1.71, 95% CI (− 2.91 to − 0.50), p = 0.005]; [OR = 0.21, 95% CI (0.05 to 0.96), p = 0.04]. Complication rates were statistically similar between the groups, except for groin pain which was higher in TOT / TVT-O. Conclusion Our data suggest that C-NDL slings have similar short-term efficacy as TOT/TVT-O in curing SUI patients. Compared with TOT/TVT-O, C-NDL is associated with a shorter operative time, and the incidence of postoperative pain is decreased. Nevertheless, these findings should be further confirmed through large-volume, well-designed prospective randomized controlled trials (RCTs) with long-term follow-up.
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Campos-Delgado M, Quetglas-Muñoz C, Barahona-Orpinell M, García-Tejedor A, Ponce-Sebastià J. Ambulatory MiniArc Precise Sling under Local Anesthesia for Stress Urinary Incontinence: Feasibility and Outcome. Gynecol Minim Invasive Ther 2019; 8:113-117. [PMID: 31544021 PMCID: PMC6743235 DOI: 10.4103/gmit.gmit_104_18] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2018] [Revised: 04/11/2019] [Accepted: 04/25/2019] [Indexed: 11/04/2022] Open
Abstract
Aims: The aim of the study is to assess the feasibility of ambulatory stress urinary incontinence (SUI) surgery using the MiniArc Precise single-incision urethral sling without increasing the number of complications. Settings and Design: This was a retrospective observational study of prospectively collected data carried out in a Tertiary Referral Hospital in Barcelona, Spain. Materials and Methods: Forty patients diagnosed with SUI or stress predominant mixed urinary incontinence (MUI) treated surgically between November 2011 and November 2013. The MiniArc Precise® sling was inserted under local anesthesia in the ambulatory setting. Statistical Analysis Used: Descriptive statistics included frequencies and percentages for categorical variables and mean and range for quantitative variables. The statistical package used was SPSS version 17.0. Results: Urodynamic studies showed SUI in 78% of cases and stress predominant MUI in 17%. Clinical findings included SUI in 56% of cases and MUI in 44%, with positive stress tests in all participants. The mean intraoperative pain (1–10 Visual Analog Scale) was 2. All patients were satisfied with the use of local anesthesia in the outpatient setting. Perioperative complications did not occur. One case of urinary retention and two cases of urinary tract infection (UTI) developed within this 1st month after operation and were successfully managed conservatively. Midterm complications included eight cases of UTI and four de novo urge incontinence. Conclusions: Placement of the MiniArc Precise sling under local anesthesia is a feasible and safe technique, which when carried out by an experienced surgeon allows to be done as an outpatient basis without increasing the rate of postprocedural complications.
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Affiliation(s)
- Miriam Campos-Delgado
- Department of Gynecology, Bellvitge University Hospital, L'hospitalet De Llobregat, Barcelona, Spain
| | - Cecilia Quetglas-Muñoz
- Department of Gynecology, Bellvitge University Hospital, L'hospitalet De Llobregat, Barcelona, Spain
| | - Marc Barahona-Orpinell
- Department of Gynecology, Bellvitge University Hospital, L'hospitalet De Llobregat, Barcelona, Spain
| | - Amparo García-Tejedor
- Department of Gynecology, Bellvitge University Hospital, L'hospitalet De Llobregat, Barcelona, Spain
| | - Jordi Ponce-Sebastià
- Department of Gynecology, Bellvitge University Hospital, L'hospitalet De Llobregat, Barcelona, Spain
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Khandwala S. Prospective Analysis of the Dynamic Intraoperative Standing Sling Technique A Novel Method of Performing the Single-Incision Sling Procedure. J Gynecol Surg 2019. [DOI: 10.1089/gyn.2018.0073] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Affiliation(s)
- Salil Khandwala
- Faculty, Wayne State University School of Medicine and Advanced Urogynecology of Michigan, Dearborn, MI
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17
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[Mini-sling versus transobturator sling: Efficiency and morbidity]. ACTA ACUST UNITED AC 2018; 46:673-680. [PMID: 30301618 DOI: 10.1016/j.gofs.2018.09.008] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2018] [Indexed: 12/16/2022]
Abstract
OBJECTIVE To compare the effectiveness of an ALTIS® mini-sling and a conventionnal suburethral sling TVT-ABBREVO® for treatment of female stress urinary incontinence. METHODS A single-center retrospective study included all female patients fitted with a conventional transobturator tape (TVT-ABBREVO®) or mini-sling (ALTIS®), during 2015, in Angers university hospital. The success rate was defined by no urine leakage during a cough test on clinical examination, improved quality of life defined by a PGI-I (Patient Global Impression of Improvement) score of 1 to 3, and no stress urinary incontinence on USP (Urinary Symptom Profile) questionnaire. Morbidity associated with slings and perioperative data were also recorded. RESULTS Ninety-two patients were included (39 in the ALTIS group and 53 in the ABBREVO group). The average follow-up was 13.55 months. The success rate was not significantly different in ALTIS group for the negative cough test (89.7% vs 94.3% in ABBREVO group, P=0.45), for the absence of urinary leakage reported on the USP questionnaire (87.2% vs 90.6% in ABBREVO group, P=0.61), or for the improvement of the quality of life with a PGI-I score between 1 and 3 (82.1% vs 86.8% in ABBREVO group, P=0.53). On the other hand, more patients were fully satisfied, with a PGI-I quality of life score of 1, in ABBREVO group than in ALTIS group (67.9% compared with 46.2%, P=0.03). Immediate postoperative pain was significantly less intense in ALTIS group than in ABBREVO group (average VAS score of 0.5 comparated with 1.3, P=0.01), but this difference had disappeared one week after surgery. The rates of other complications were similar in both groups. CONCLUSION The functional results of the ALTIS and TVT-ABBREVO® slings appear similar in the treatment of female stress urinary incontinence.
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Kim A, Kim MS, Park YJ, Choi WS, Park HK, Paick SH, Choo MS, Kim HG. Clinical outcome of single-incision slings, excluding TVT-Secur, vs standard slings in the surgical management of stress incontinence: an updated systematic review and meta-analysis. BJU Int 2018; 123:566-584. [DOI: 10.1111/bju.14447] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Affiliation(s)
- Aram Kim
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Min Seo Kim
- College of Medicine; Korea University; Seoul Korea
| | - Young-Jin Park
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Woo Suk Choi
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Hyoung Keun Park
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Sung Hyun Paick
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Myung-Soo Choo
- Department of Urology; Asan Medical Centre; Ulsan University College of Medicine; Seoul Korea
| | - Hyeong Gon Kim
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
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Pascom AL, Djehdian LM, Bortolini MA, Jarmy-Di Bella ZI, Delroy CA, Tamanini JT, Castro RA. Randomized controlled trial comparing single-incision mini-sling and transobturator midurethral sling for the treatment of stress urinary incontinence: 3-year follow-up results. Neurourol Urodyn 2018; 37:2184-2190. [DOI: 10.1002/nau.23546] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2017] [Accepted: 02/05/2018] [Indexed: 11/08/2022]
Affiliation(s)
- Ana L.G. Pascom
- Department of Gynecology; Federal University of São Paulo; São Paulo Brazil
| | | | | | | | - Carlos A. Delroy
- Department of Gynecology; Federal University of São Paulo; São Paulo Brazil
| | - Jose T.N. Tamanini
- Department of Gynecology; Federal University of São Paulo; São Paulo Brazil
| | - Rodrigo A. Castro
- Department of Gynecology; Federal University of São Paulo; São Paulo Brazil
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Jiao B, Lai S, Xu X, Zhang M, Diao T, Zhang G. A systematic review and meta-analysis of single-incision mini-slings (MiniArc) versus transobturator mid-urethral slings in surgical management of female stress urinary incontinence. Medicine (Baltimore) 2018; 97:e0283. [PMID: 29620645 PMCID: PMC5902257 DOI: 10.1097/md.0000000000010283] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Abstract
BACKGROUND To assess the current evidence of effectiveness and safety of single-incision mini-slings (MiniArc) versus transobturator midurethral slings in the management of female stress urinary incontinence (SUI). METHODS A systematic search was performed from the electronic databases including PubMed, EMBASE, and Cochrane Library by November 2017. Using RevMan5.3 statistical software, the primary outcomes including subject and objective cure rates at 6 to 24 months follow-up were evaluated. Meanwhile, analysis was also performed for comparing the secondary outcomes such as peri- and postoperative complications, operative data, and quality of life. RESULTS Six randomized controlled trials (RCTs) and 6 retrospective cohort studies involving 1794 patients with SUI were analyzed based on the inclusion criteria. On the basis of our analysis, MiniArc was proven to have a noninferior clinical efficacy compared with transobturator midurethral slings with respect to the objective cure rate (risk ratio [RR] = 0.98, 95% confidence interval [CI] 0.94-1.03, P = .43) and subjective cure rate (RR = 0.97, 95% CI 0.91-1. 04, P = .38). In addition, pooled analysis showed that MiniArc had significantly lower postoperative pain scores (mean difference [MD] = -1.70, 95% CI -3.17 to -0.23, P = .02) and less postoperative groin pain (RR = 0.42, 95% CI 0.18-0.98, P = .04). Moreover, the MiniArc group also had a significantly shorter operation time (MD = -6.12, 95% CI -8.61 to -3.64, P < .001), less blood loss (MD = -16.67, 95% CI -26.29 to -7.05, P < .001), shorter in-patient stay (MD = 1.30, 95% CI -1.74 to -0.86, P < .001), and less urinary retention risk (RR = 1.15, 95% CI 0.46-2.87, P = .77). However, overall evidence was insufficient to suggest a statistically significant difference in the adverse event profile for MiniArc compared with transobturator slings. CONCLUSIONS This meta-analysis indicates that MiniArc is an effective method treating SUI. When compared with transobturator slings, it not only has a similar high cure rates, but also is associated with shorter operation time, less blood loss, more favorable recovery time, lower postoperative pain scores, less postoperative groin pain, less urinary retention, and absence of a visible wound. However, the findings of this study should be further confirmed by well-designed prospective RCTs with a larger patient series.
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Affiliation(s)
- Binbin Jiao
- Peking University China-Japan Friendship School of Clinical Medicine
- Department of Urology, China-Japan Friendship Hospital, Chaoyang
| | - Shicong Lai
- Peking University China-Japan Friendship School of Clinical Medicine
- Department of Urology, China-Japan Friendship Hospital, Chaoyang
| | - Xin Xu
- Peking University China-Japan Friendship School of Clinical Medicine
| | - Meng Zhang
- Peking University China-Japan Friendship School of Clinical Medicine
- Department of Urology, China-Japan Friendship Hospital, Chaoyang
| | - Tongxiang Diao
- Peking University Fifth School of Clinical Medicine
- Department of Urology, Beijing Hospital, Dongcheng, Beijing, China
| | - Guan Zhang
- Peking University China-Japan Friendship School of Clinical Medicine
- Department of Urology, China-Japan Friendship Hospital, Chaoyang
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A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results. Int Urogynecol J 2018; 29:1387-1395. [PMID: 29549394 DOI: 10.1007/s00192-018-3624-4] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2017] [Accepted: 03/01/2018] [Indexed: 10/17/2022]
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James MB, Theofanides MC, Sui W, Onyeji I, Badalato GM, Chung DE. Sling Procedures for the Treatment of Stress Urinary Incontinence: Comparison of National Practice Patterns between Urologists and Gynecologists. J Urol 2017; 198:1386-1391. [DOI: 10.1016/j.juro.2017.06.093] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/27/2017] [Indexed: 11/25/2022]
Affiliation(s)
- Maxwell B. James
- Department of Urology, Columbia University Medical Center, New York, New York
| | | | - Wilson Sui
- Department of Urology, Columbia University Medical Center, New York, New York
| | - Ifeanyi Onyeji
- Department of Urology, Columbia University Medical Center, New York, New York
| | - Gina M. Badalato
- Department of Urology, Columbia University Medical Center, New York, New York
| | - Doreen E. Chung
- Department of Urology, Columbia University Medical Center, New York, New York
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Nambiar A, Cody JD, Jeffery ST, Aluko P, Cochrane Incontinence Group. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2017; 7:CD008709. [PMID: 28746980 PMCID: PMC6483163 DOI: 10.1002/14651858.cd008709.pub3] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
BACKGROUND Urinary incontinence has been shown to affect up to 50% of women. Studies in the USA have shown that up to 80% of these women have an element of stress urinary incontinence. This imposes significant health and economic burden on society and the women affected. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation. This has led to the development of third-generation single-incision slings, also referred to as mini-slings.It should be noted that TVT-Secur (Gynecare, Bridgewater, NJ, USA) is one type of single-incision sling; it has been withdrawn from the market because of poor results. However, it is one of the most widely studied single-incision slings and was used in several of the trials included in this review. Despite its withdrawal from clinical use, it was decided that data pertaining to this sling should be included in the first iteration of this review, so that level 1a data are available in the literature to confirm its lack of efficacy. OBJECTIVES To assess the effectiveness of mini-sling procedures in women with urodynamic clinical stress or mixed urinary incontinence in terms of improved continence status, quality of life or adverse events. SEARCH METHODS We searched: Cochrane Incontinence Specialised Register (includes: CENTRAL, MEDLINE, MEDLINE In-Process) (searched 6 February 2013); ClinicalTrials.gov, WHO ICTRP (searched 20 September 2012); reference lists. SELECTION CRITERIA Randomised or quasi-randomised controlled trials in women with urodynamic stress incontinence, symptoms of stress incontinence or stress-predominant mixed urinary incontinence, in which at least one trial arm involves one of the new single-incision slings. The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)." DATA COLLECTION AND ANALYSIS Three review authors assessed the methodological quality of potentially eligible trials and independently extracted data from individual trials. MAIN RESULTS We identified 31 trials involving 3290 women. Some methodological flaws were observed in some trials; a summary of these is given in the 'Risk of bias in included studies' section.No studies compared single-incision slings versus no treatment, conservative treatment, colposuspension, laparoscopic procedures or traditional sub-urethral slings. No data on the comparison of single-incision slings versus retropubic mid-urethral slings (top-down approach) were available, but the review authors believe this did not affect the overall comparison versus retropubic mid-urethral slings.Types of single-incision slings included in this review: TVT-Secur (Gynecare); MiniArc (American Medical Systems, Minnetonka, USA); Ajust (CR Bard Inc., Covington, USA); Needleless (Mayumana Healthcare, Lisse, The Netherlands); Ophira (Promedon, Cordoba, Argentina); Tissue Fixation System (TFS PTY Ltd, Sydney, Australia) and CureMesh (DMed Co. Inc., Seoul, Korea).Women were more likely to remain incontinent after surgery with single-incision slings than with retropubic slings such as tension-free vaginal tape (TVTTM) (121/292, 41% vs 72/281, 26%; risk ratio (RR) 2.08, 95% confidence interval (CI) 1.04 to 4.14). Duration of the operation was slightly shorter for single-incision slings but with higher risk of de novo urgency (RR 2.39, 95% CI 1.25 to 4.56). Four of five studies in the comparison included TVT-Secur as the single-incision sling.Single-incision slings resulted in higher incontinence rates compared with inside-out transobturator slings (30% vs 11%; RR 2.55, 95% CI 1.93 to 3.36). The adverse event profile was significantly worse, specifically consisting of higher risks of vaginal mesh exposure (RR 3.75, 95% CI 1.42 to 9.86), bladder/urethral erosion (RR 17.79, 95% CI 1.06 to 298.88) and operative blood loss (mean difference 18.79, 95% CI 3.70 to 33.88). Postoperative pain was less common with single-incision slings (RR 0.29, 95% CI 0.20 to 0.43), and rates of long-term pain or discomfort were marginally lower, but the clinical significance of these differences is questionable. Most of these findings were derived from the trials involving TVT-Secur: Excluding the other trials showed that high risk of incontinence was principally associated with use of this device (RR 2.65, 95% CI 1.98 to 3.54). It has been withdrawn from clinical use.Evidence was insufficient to reveal a difference in incontinence rates with other single-incision slings compared with inside-out or outside-in transobturator slings. Duration of the operation was marginally shorter for single-incision slings compared with transobturator slings, but only by approximately two minutes and with significant heterogeneity in the comparison. Risks of postoperative and long-term groin/thigh pain were slightly lower with single-incision slings, but overall evidence was insufficient to suggest a significant difference in the adverse event profile for single-incision slings compared with transobturator slings. Evidence was also insufficient to permit a meaningful sensitivity analysis of the other single-incision slings compared with transobturator slings, as all confidence intervals were wide. The only significant differences were observed in rates of postoperative and long-term pain, and in duration of the operation, which marginally favoured single-incision slings.Overall results show that TVT-Secur is considerably inferior to retropubic and inside-out transobturator slings, but additional evidence is required to allow any reasonable comparison of other single-incision slings versus transobturator slings.When one single-incision sling was compared with another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made. AUTHORS' CONCLUSIONS TVT-Secur is inferior to standard mid-urethral slings for the treatment of women with stress incontinence and has already been withdrawn from clinical use. Not enough evidence has been found on other single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons. A brief economic commentary (BEC) identified two studies which reported no difference in clinical outcomes between single-incision slings and transobturator mid-urethral slings, but single-incision slings may be more cost-effective than transobturator mid-urethral slings based on one-year follow-up. Additional adequately powered and high-quality trials with longer-term follow-up are required. Trials should clearly describe the fixation mechanism of these single-incisions slings: It is apparent that, although clubbed together as a single group, a significant difference in fixation mechanisms may influence outcomes.
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Affiliation(s)
- Arjun Nambiar
- Health Education North East/Freeman HospitalDepartment of UrologyFreeman RoadHigh HeatonNewcastle‐upon‐TyneTyne and WearUKNE7 7DN
| | - June D Cody
- Newcastle Universityc/o Cochrane Incontinence GroupInstitute of Health & SocietyBaddiley‐Clarke Building, Richardson RoadNewcastle upon TyneTyne and WearUKNE2 4AX
| | - Stephen T Jeffery
- Groote Schuur Hospital and University of Cape TownObstetrics and GynaecologyAnzio RoadObservatoryCape TownWestern CapeSouth Africa8001
| | - Patricia Aluko
- Newcastle UniversityInstitute of Health and SocietyRichardson RoadNewcastle Upon TyneUKNE2 4AX
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Shamout S, Campeau L. Stress urinary incontinence in women: Current and emerging therapeutic options. Can Urol Assoc J 2017; 11:S155-S158. [PMID: 28616118 DOI: 10.5489/cuaj.4613] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/14/2023]
Abstract
Surgical management of stress urinary incontinence (SUI) is most commonly achieved by midurethral synthetic sling (MUS) insertion as a first-line surgical option. A great deal of research continues to evolve new management strategies to reach an optimal balance of high efficacy and minimal adverse events. This expert opinion review provides a brief and comprehensive discussion of recent advances and ongoing research in the management of SUI, with an emphasis on single-incision mini-slings, vaginal laser treatment, and cell-based therapy. It is based on data obtained from numerous published meta-analyses and original studies identified through literature search. Single-incision mini-slings appear equally effective initially compared with standard MUS (retropubic or transobturator) for the treatment of female SUI; however, this efficacy lacks durability evidence beyond one-year followup. There is a lack of sufficient clinical evidence to currently confirm long-term safety and effectiveness of cell-therapy and non-ablative vaginal laser therapy, besides suggestion of apparent initial safety. There are still significant challenges to overcome before widespread clinical practice of the latter two modalities. Future research should be aimed at identifying groups of patients who might benefit from these minimally invasive therapeutic options.
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Affiliation(s)
- Samer Shamout
- Division of Urology, Department of Surgery, McGill University, Montreal, QC, Canada
| | - Lysanne Campeau
- Division of Urology, Department of Surgery, McGill University, Montreal, QC, Canada
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Schellart RP, Zwolsman SE, Lucot JP, de Ridder DJMK, Dijkgraaf MGW, Roovers JPWR. A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence. Int Urogynecol J 2017; 29:37-44. [DOI: 10.1007/s00192-017-3362-z] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2016] [Accepted: 05/02/2017] [Indexed: 12/14/2022]
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O'Boyle AL, Chung CP, Larsen W. Anatomic Relation Between Single-Incision Slings and the Obturator Vessels. Proc (Bayl Univ Med Cent) 2017; 30:154-156. [DOI: 10.1080/08998280.2017.11929565] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022] Open
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Anding R, Schoen M, Kirschner-Hermanns R, Fisang C, Müller SC, Latz S. Minimally invasive treatment of female stress urinary incontinence with the adjustable single-incision sling system (AJUST ™) in an elderly and overweight population. Int Braz J Urol 2017; 43:280-288. [PMID: 28128907 PMCID: PMC5433368 DOI: 10.1590/s1677-5538.ibju.2015.0751] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2015] [Accepted: 10/15/2016] [Indexed: 11/22/2022] Open
Abstract
Introduction The prevalence of urinary incontinence is increasing. Two major risk factors are overweight and age. We present objective and subjective cure rates of elderly and overweight patients treated with an adjustable single-incision sling system (AJUST™, C.R. BARD, Inc.). Materials and Methods Between 04/2009 and 02/2012 we treated 100 female patients with the single incision sling. Patients were retrospectively evaluated by Stamey degree of incontinence, cough test, pad use, and overall satisfaction. The primary outcomes of the study were objective and subjective cure rates, secondary outcomes were the safety profile of the sling and complications. Results The overall success rate in this population was 84.6% with a mean follow-up of 9.3 months. The average usage of pads per day decreased from 4.9 to 1.6 and was significantly lower in patients with a BMI <30 (p=0.004). Postoperative residual SUI was also lower in patients with a BMI <30 (p=0.006). Postoperative satisfaction was better in patients with a lower BMI, but this difference did not reach a level of significance (p=0.055). There were no complications such as bleeding, bladder injury, or tape infection. Conclusions In elderly and obese patients a considerable success rate is achievable with this quick and minimal invasive procedure. However, the success rate shows a clear trend in favor of a lower body-mass-index. The cut-off point has been identified at a BMI of 30. The AJUST™ system can be regarded as safe and beneficial for elderly and obese patients.
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Affiliation(s)
- Ralf Anding
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
| | - Manuel Schoen
- Department of Urology, Klinikum Ibbenbueren GmbH, Germany
| | | | - Christian Fisang
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
| | - Stefan C Müller
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
| | - Stefan Latz
- Department of Urology and Neuro-Urology, University Hospital Bonn, Germany
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Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling. Int Urogynecol J 2016; 28:1041-1047. [DOI: 10.1007/s00192-016-3221-3] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2016] [Accepted: 11/21/2016] [Indexed: 11/25/2022]
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Does the design of mini slings anchoring systems really matter? A biomechanical comparison between Mini Arc™ and Ophira™. Actas Urol Esp 2016; 40:564-569. [PMID: 27168499 DOI: 10.1016/j.acuro.2016.02.009] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2015] [Revised: 02/22/2016] [Accepted: 02/22/2016] [Indexed: 11/22/2022]
Abstract
INTRODUCTION AND HYPOTHESIS Currently, a sling implant is the standard treatment for stress urinary incontinence in women. To be effective, they require an adequate anchoring system. The aim of this study is compare biomechanical features of fixation systems of two mini slings models available on the market (Ophira™ and Mini Arc™) through a tensile test. MATERIALS AND METHODS Anchoring devices of each sling were surgically implanted in abdominal wall of 15 rats divided into three groups of five animals which were arranged according to the date of post implant euthanasia on 7, 14 and 30 days. Abdominal walls of rats were extracted on bloc containing the anchoring system and were submitted to a tensile strength test to measure the maximum load and elongation until device avulsion from the tissue. The results were compared using Student test t and a 5% cut off was considered significant. RESULTS The Ophira™ mini sling fixation system demanded a greater maximum load and developed a longer stretch for avulsion from the implanted site at all moments evaluated (p value less than 0.05). CONCLUSION There were significant differences in fixation patterns of the anchoring systems, which were exclusively related to their designs. The Ophira™ mini sling fixation device provided better fixation to the abdominal wall of rats compared to the Mini Arc™ device, even in the late post implant period.
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Levi A, Nasra R, Shachar IB, Braun NM. Medium-term results of Mini-arc for urinary stress incontinence in ambulatory patients under local anesthesia. Int Braz J Urol 2016; 42:1195-1201. [PMID: 27813384 PMCID: PMC5117977 DOI: 10.1590/s1677-5538.ibju.2015.0655] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2015] [Revised: 07/21/2016] [Accepted: 07/21/2016] [Indexed: 11/25/2022] Open
Abstract
OBJECTIVE To evaluate the medium-term outcome and patient's satisfaction after Single-incision mini-sling (SIMS) procedure done under local anesthesia in ambulatory set up for patients with stress urinary incontinence (SUI). MATERIALS AND METHODS This is a retrospective cohort study, including all patients submitted to SIMS procedure for SUI with MiniArc (AMS, U.S.A) without concomitant surgery between January 2011 and March 2013. Patients were followed up during 12 months after surgery and once a year subsequently. Telephone interviews were conducted to evaluate patient satisfaction. Outcome masseurs included: SUI cure rate, urinary urge incontinence (UUI) cure rate in patients with mixed urinary incontinence (MUI), intra and post-operative complications and patient satisfaction. RESULTS Ninety-three patients were included with mean follow-up of 23 months. Fifty percent had MUI with predominant SUI. The cure rates of SUI (objective and subjective) were 89%. UUI was cured in 40% of patients. No major complications occur, neither voiding obstruction or groin pain. Telephone interviews conducted after 26 months on average revealed high satisfaction rate from the procedure (8.8 out of 10) and from the local anesthesia. Visual analog scale (VAS) rating was low during and after the procedure (2.38 and 2.69 respectively). CONCLUSIONS The SIMS procedure is safe and highly effective for SUI and it can be performed successfully under local anesthesia in an ambulatory setup.
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Affiliation(s)
- Almog Levi
- Department of Obstetrics and Gynecology, Ziv Medical Center, Faculty of Medicine, Bar-Ilan University, Safed, Israel
| | - Rasha Nasra
- Department of Obstetrics and Gynecology, Ziv Medical Center, Faculty of Medicine, Bar-Ilan University, Safed, Israel
| | - Inbar Ben Shachar
- Department of Obstetrics and Gynecology, Ziv Medical Center, Faculty of Medicine, Bar-Ilan University, Safed, Israel
| | - Naama Marcus Braun
- Department of Obstetrics and Gynecology, Ziv Medical Center, Faculty of Medicine, Bar-Ilan University, Safed, Israel
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31
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Gaber ME, Borg T, Samour H, Nawara M, Reda A. Two new mini-slings compared with transobturator tension-free vaginal tape for treatment of stress urinary incontinence: A 1-year follow-up randomized controlled trial. J Obstet Gynaecol Res 2016; 42:1773-1781. [DOI: 10.1111/jog.13143] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2016] [Accepted: 07/18/2016] [Indexed: 12/01/2022]
Affiliation(s)
- Mohamed E. Gaber
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
- Obstetrics and Gynecology Department; Heart of England NHS hospital; Sutton Coldfield UK
| | - Tamer Borg
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
| | - Hazem Samour
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
| | - Mai Nawara
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
| | - Ahmed Reda
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
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Tieu AL, Hegde A, Castillo PA, Davila GW, Aguilar VC. Transobturator versus single incision slings: 1-year results of a randomized controlled trial. Int Urogynecol J 2016; 28:461-467. [DOI: 10.1007/s00192-016-3128-z] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2016] [Accepted: 08/18/2016] [Indexed: 10/20/2022]
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Schellart RP, Casteleijn FM, Dijkgraaf MGW, Tutolo M, Roovers JPWR. Are patients willing to trade cure rate against less pain? Patients' preferences for single incision midurethral sling or transobturator standard midurethral sling. Neurourol Urodyn 2016; 36:1187-1193. [PMID: 27564322 DOI: 10.1002/nau.23093] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2016] [Accepted: 07/29/2016] [Indexed: 12/31/2022]
Abstract
AIMS To quantify to what extent patients are willing to trade their chance of cure of stress urinary incontinence (SUI) against less postoperative groin pain. Randomized, controlled trials show less postoperative pain following single-incision mini-sling (SIMS), but slightly higher cure rates following a transobturator standard midurethral sling (SMUS). METHODS A multi-center, interview-based trade-off experiment for treatment preference among 100 women with predominant SUI and undergoing SIMS. A hypothetical cure rate of SIMS was systematically varied from 10% to 70%, while keeping the cure rate of SMUS constant at 70%. The trade-off was assessed for two hypothetical durations of substantial postoperative pain after SMUS-2 days or 2 weeks-while simultaneously assuming the absence of substantial postoperative pain after SIMS. RESULTS To prevent 2 days of substantial postoperative pain with SMUS, patients were willing to accept a 4.3% mean decrease in cure rate of SIMS, while a 7.1% mean decrease was acceptable to forego 2 weeks of substantial pain. Younger women (P = 0.04) and single women (P = 0.04) were associated with the trade-off limit for 2 days, respectively, 2 weeks of substantial postoperative pain. Single women were willing to accept lower cure rates. No correlations with trade-off limits were found for patients' actual severity, duration, and frequency of SUI. CONCLUSIONS Patients are willing to accept a slightly lower probability of cure to prevent substantial post-operative pain by undergoing a less invasive procedure. These results are relevant for counselling of patients indicated for SUI surgery.
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Affiliation(s)
- René P Schellart
- Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands
| | - Fenne M Casteleijn
- Department of Obstetrics and Gynaecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands
| | - Marcel G W Dijkgraaf
- Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands
| | - Manuela Tutolo
- Department of Urology, University Hospitals Leuven, Leuven, Belgium
| | - Jan-Paul W R Roovers
- Department of Obstetrics and Gynaecology, Academic Medical Center Amsterdam, Amsterdam, The Netherlands
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Abstract
Urinary incontinence (UI) is more common than any other chronic disease, such as hypertension, depression or diabetes, with the prevalence estimated between 9 and 74%. Among the various forms of urinary incontinence, stress incontinence (SUI) is the most prevalent (50%), with urgency incontinence (UUI) representing 11% and mixed type (MUI) 36% (3% not classified). Nowadays, the restoration of urinary continence is one of the greatest challenges for the well-being and quality of life of women. The introduction of minimally invasive surgical procedures changed the anti-incontinence surgery, leading to similar, or even better results as traditional, invasive techniques. The development of the mid-urethral slings offers a viable alternative to surgical correction of SUI. These further developments of mini-sling procedures are appropriate for local anesthesia, less traumatic, 'tension-free' (to ensure continence without obstruction), simple, rapid and repeatable. The latest minimally invasive approaches can be performed in day surgery, with clear advantages compared to traditional procedures. A novel approach through the use of vaginal laser techniques could represent an additional opportunity, as a non-invasive, outpatient method to treat SUI.
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Affiliation(s)
- M Cervigni
- a Department of Women's Health and New Life , Catholic University , Rome , Italy
| | - M Gambacciani
- b * Department of Obstetrics and Gynecology , Pisa University Hospital , Pisa , Italy
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Tutolo M, De Ridder D, Van der Aa F. Single incision slings: Are they ready for real life? World J Obstet Gynecol 2016; 5:197-209. [DOI: 10.5317/wjog.v5.i2.197] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2015] [Revised: 11/23/2015] [Accepted: 01/22/2016] [Indexed: 02/05/2023] Open
Abstract
AIM: To review of the efficacy and safety outcomes of different single incision slings (SIS) systems, also in comparison with traditional slings.
METHODS: A literature search was conducted in PubMed/MEDLINE database. The research was restricted to randomized and/or prospective trials and retrospective studies, published after 2006, with at least 20 patients with non-neurogenic stress urinary incontinence (SUI). The studies had to assess efficacy and/or safety of the SIS with a minimum follow-up of 12 mo. All the paper assessing the performance of tension free vaginal tape secur were excluded from this review. The final selection included 19 papers fulfilling the aforementioned criteria. Two authors independently reviewed the selected papers.
RESULTS: Four different SIS systems were analysed: Ajust®, Ophira®, Altis® and MiniArc®. The average objective cure rate was 88%. Overall no statistically significant differences were found between SIS and traditional mid-urethral slings (MUS) in terms of objective cure (all P > 0.005). Only one paper showed a statistically lower success rate in MiniArc®vs Advantage® slings (40% vs 90%) and higher rates of failure in the SIS group. Since there was a great variability in terms of tests performed, it was not possible to compare subjective cure between studies. The vast part of the studies showed no major complications after SIS surgery. We also observed very low reported pain rates in SIS patients. The RCTs on Ajust® and MiniArc®, showed better outcomes in terms of post-operative pain compared to MUS. None of the patients reported long- term pain complains.
CONCLUSION: SIS showed similar efficacy to that of traditional slings but lower short-term pain, complication and failure rates.
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Tutolo M, De Ridder DJ, Montorsi F, Castagna G, Deprest J, Schellart RP, Ammirati E, Van Der Aa F. A minimum of 1-year follow-up for MiniArc single incision slings compared to Monarc transobturator slings: An analysis to evaluate durability of continence and medium-term outcomes. Neurourol Urodyn 2016; 36:803-807. [DOI: 10.1002/nau.23036] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2015] [Accepted: 04/25/2016] [Indexed: 11/05/2022]
Affiliation(s)
- Manuela Tutolo
- Department of Urology; University Hospitals Leuven; Leuven Belgium
- Division of Oncology/Unit of Urology; Urological Research Institute; IRCCS Ospedale San Raffaele; Milan Italy
| | | | - Francesco Montorsi
- Division of Oncology/Unit of Urology; Urological Research Institute; IRCCS Ospedale San Raffaele; Milan Italy
| | - Giulia Castagna
- Division of Oncology/Unit of Urology; Urological Research Institute; IRCCS Ospedale San Raffaele; Milan Italy
| | - Jan Deprest
- Department of Obstetrics and Gynecology; University Hospitals Leuven; Leuven Belgium
| | - Renè P. Schellart
- Department of Obstetrics and Gynecology; Spaarne Gasthuis; Harlem The Netherlands
| | - Enrico Ammirati
- Division of Urology Torino; Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino; Piemonte Italy
| | - Frank Van Der Aa
- Department of Urology; University Hospitals Leuven; Leuven Belgium
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Female sexual function following mid-urethral slings for the treatment of stress urinary incontinence. Int J Impot Res 2016; 28:121-6. [DOI: 10.1038/ijir.2016.16] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2015] [Revised: 06/17/2015] [Accepted: 12/09/2015] [Indexed: 11/08/2022]
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Have mini-slings come of age? Curr Opin Urol 2016; 25:296-9. [PMID: 26049871 DOI: 10.1097/mou.0000000000000183] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
PURPOSE OF REVIEW To highlight the recent data published about mini-slings for management of female stress urinary incontinence, focusing on the past 12 months. RECENT FINDINGS Mini-slings, implanted by single vaginal incision, have been increasingly used in recent years. SUMMARY A significant number of new clinical trials have investigated the efficacy of single incision mini-slings (SIMS) in the past years. Meta-analyses have shown growing evidence supporting their use, but a number of limitations go against a wide, immediate, and unconditional diffusion of these techniques. First, the majority of the trials published investigated the TVT-Secur device, which is considered to be inferior to traditional slings and is no more used in clinical practice. All other SIMS have been tested in clinical trials but there is insufficient evidence to routinely recommend their use, mainly because long-term data are lacking. SIMS have to be considered as a heterogeneous group, and results obtained with one device cannot be translated to another. The safety profile of recently introduced SIMS seems good, with potential reduction of postoperative pain and faster recovery. However, further research is necessary to clearly establish their noninferiority regarding efficacy after 1 year compared to traditional transobturator tapes and TVT, and ascertain their benefits in daily clinical practice.
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Intraoperative Ultrasound-Guided Removal of Retained Mini Sling Anchor Causing Vaginal Pain. Female Pelvic Med Reconstr Surg 2016; 22:e17-9. [DOI: 10.1097/spv.0000000000000236] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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Sharifiaghdas F, Nasiri M, Mirzaei M, Narouie B. Mini Sling (Ophira) versus Pubovaginal Sling for Treatment of Stress Urinary Incontinence: A Medium-term Follow-up. Prague Med Rep 2015; 116:210-8. [PMID: 26445392 DOI: 10.14712/23362936.2015.60] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022] Open
Abstract
To compare two different procedures, mid-urethral mini sling (Ophira) and autologous rectus fascia sling, according to their medium-term subjective and objective outcome and satisfaction rates in the treatment of stress urinary incontinence in women. One hundred women with the main complaint of stress urinary incontinence were randomized to be treated with either mini sling (Ophira) or autologous rectus facia pubovaginal sling. Preoperative evaluation consisted of: physical examination, blood biochemistry urine analysis and culture, urinary tract ultrasound scan, conventional multi-channel urodynamic study, cystourethroscopy, cough induced stress test and Incontinence Impact Questionnaire (IIQ). The patients were objectively and subjectively re-evaluated at 1, 3, 6 and 12 postoperative months and the last visit and the collected data of more than one year follow-up were compared with preoperative assessments. Seventy two out of one hundred patients were followed for a mean time of 13.8±4.4 months (12-20 months range). Objective cure rate, according to cough-induced stress test was recorded in 88.6% and 89.2% of the mini sling (Ophira) and the rectus facia sling group respectively (P=1.0). Postoperative mean IIQ score decreased to 42.7±11.4 and 50.2±11.1 in the mini sling (Ophira) group versus rectus facia pubovaginal sling (P=0.007). Twenty eight (80%) and 23 (67%) patients in the mini sling (Ophira) and rectus facia pubovaginal sling were satisfied with the operation (P=0.23). There is no significant difference between the mini sling (Ophira) and autologous rectus fascia sling procedure in the treatment of stress urinary incontinence at medium-term follow-up.
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Affiliation(s)
- Farzaneh Sharifiaghdas
- Urology and Nephrology Research Center, Department of Urology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mahmoodreza Nasiri
- Urology and Nephrology Research Center, Department of Urology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mahboubeh Mirzaei
- Department of Urology, Kerman University of Medical Sciences, Kerman, Iran
| | - Behzad Narouie
- Department of Urology, Zahedan University of Medical Sciences, Zahedan, Iran. .,Urology and Nephrology Research Center, Department of Urology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
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Chang CP, Chang WH, Hsu YM, Chen YJ, Wen KC, Chao KC, Yen MS, Horng HC, Wang PH, Chuang CM, Chang YH, Wu HH, Lau HY, Tseng JY, Tsai HW, Twu NF, Chao HT. Comparison of single-incision mini-slings (Ajust) and standard transobturator midurethral slings (Align) in the management of female stress urinary incontinence: A 1-year follow-up. Taiwan J Obstet Gynecol 2015; 54:726-30. [DOI: 10.1016/j.tjog.2015.10.007] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/08/2015] [Indexed: 01/15/2023] Open
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Takahashi S, Takei M, Nishizawa O, Yamaguchi O, Kato K, Gotoh M, Yoshimura Y, Takeyama M, Ozawa H, Shimada M, Yamanishi T, Yoshida M, Tomoe H, Yokoyama O, Koyama M. Clinical Guideline for Female Lower Urinary Tract Symptoms. Low Urin Tract Symptoms 2015; 8:5-29. [PMID: 26789539 DOI: 10.1111/luts.12111] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2015] [Accepted: 06/28/2015] [Indexed: 12/16/2022]
Abstract
The "Japanese Clinical Guideline for Female Lower Urinary Tract Symptoms," published in Japan in November 2013, contains two algorithms (a primary and a specialized treatment algorithm) that are novel worldwide as they cover female lower urinary tract symptoms other than urinary incontinence. For primary treatment, necessary types of evaluation include querying the patient regarding symptoms and medical history, examining physical findings, and performing urinalysis. The types of evaluations that should be performed for select cases include evaluation with symptom/quality of life (QOL) questionnaires, urination records, residual urine measurement, urine cytology, urine culture, serum creatinine measurement, and ultrasonography. If the main symptoms are voiding/post-voiding, specialized treatment should be considered because multiple conditions may be involved. When storage difficulties are the main symptoms, the patient should be assessed using the primary algorithm. When conditions such as overactive bladder or stress incontinence are diagnosed and treatment is administered, but sufficient improvement is not achieved, the specialized algorithm should be considered. In case of specialized treatment, physiological re-evaluation, urinary tract/pelvic imaging evaluation, and urodynamic testing are conducted for conditions such as refractory overactive bladder and stress incontinence. There are two causes of voiding/post-voiding symptoms: lower urinary tract obstruction and detrusor underactivity. Lower urinary tract obstruction caused by pelvic organ prolapse may be improved by surgery.
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Affiliation(s)
- Satoru Takahashi
- Department of Urology, Nihon University School of Medicine, Tokyo, Japan
| | - Mineo Takei
- Department of Urology, Harasanshin Hospital, Fukuoka, Japan
| | - Osamu Nishizawa
- Department of Urology, Shinshu University School of Medicine, Matsumoto, Japan
| | - Osamu Yamaguchi
- Division of Bioengineering and LUTD Research, School of Engineering, Nihon University, Koriyama, Japan
| | - Kumiko Kato
- Department of Female Urology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan
| | - Momokazu Gotoh
- Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | | | | | - Hideo Ozawa
- Department of Urology, Kawasaki Hospital, Kawasaki Medical School, Kurashiki, Japan
| | - Makoto Shimada
- Department of Urology, Showa University Northern Yokohama Hospital, Yokohama, Japan
| | - Tomonori Yamanishi
- Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan
| | - Masaki Yoshida
- Department of Urology, National Center for Geriatrics and Gerontology, Obu City, Japan
| | - Hikaru Tomoe
- Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan
| | - Osamu Yokoyama
- Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan
| | - Masayasu Koyama
- Women's Lifecare Medicine, Department of Obstetrics & Gynecology, Osaka City University Graduate School of Medicine, Osaka, Japan
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What is the best surgical intervention for stress urinary incontinence in the very young and very old? An International Consultation on Incontinence Research Society update. Int Urogynecol J 2015. [DOI: 10.1007/s00192-015-2783-9] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
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Sergouniotis F, Jarlshammar B, Larsson PG. Urethral complications after tension-free vaginal tape procedures: A surgical management case series. World J Nephrol 2015; 4:396-405. [PMID: 26167464 PMCID: PMC4491931 DOI: 10.5527/wjn.v4.i3.396] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/18/2014] [Revised: 02/25/2015] [Accepted: 04/14/2015] [Indexed: 02/06/2023] Open
Abstract
AIM: To analyze the clinical features, diagnostic modalities, and the surgical management of urethral complications after tension-free vaginal tape procedures.
METHODS: This study encompasses a retrospective review of nine patients presented with urethral complications after midurethral sling procedures. The patients underwent the procedures during a period from 1999 to 2012 in three different regional hospitals in the southwest part of Sweden. The time from sling placement to diagnosis, the risk factors, clinical features, diagnosis, surgical management, and functional outcome are presented. The presenting symptoms were described as either early onset (< 12 mo) or late onset (> 12 mo) according to when they were first reported.
RESULTS: Eight cases of urethral erosion and one case of bladder-neck erosion were detected. The mean interval for diagnoses of the erosions ranged from 3 mo to 11 years. The most common presenting symptoms included de novo urgency with or without incontinence (7/9 patients), urinary retention/voiding dysfunction (4/9 patients), urethritis (4/9 patients), relapse of stress-incontinence (3/9 patients), recurrent urinary tract infections (5/9 patients), and hematuria (1/9 patient). In most cases, voiding dysfunction and urethritis occurred early after the operation. The surgical management applied in most cases was transurethral resection of the intraurethral part of the mesh. The removal of the intraurethral mesh resulted in improvement or complete cure of urgency symptoms in 5/7 patients with urgency. Four patients were reoperated with a new stress-incontinence surgery, one with laparoscopic Burch, and three with retropubic tension-free vaginal tape procedures.
CONCLUSION: Urethral complications should be suspected in the case of de novo urgency and relapse of stress-incontinence. Transurethral excision of the intraurethral mesh is the recommended treatment.
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Lee JKS, Rosamilia A, Dwyer PL, Lim YN, Muller R. Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results. Am J Obstet Gynecol 2015; 213:35.e1-35.e9. [PMID: 25637849 DOI: 10.1016/j.ajog.2015.01.040] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2014] [Revised: 01/14/2015] [Accepted: 01/26/2015] [Indexed: 12/31/2022]
Abstract
OBJECTIVE The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months. STUDY DESIGN A total of 225 women were randomized to receive MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate. RESULTS There was no statistically significant difference in the subjective (92.2% vs 94.2%; P = .78; difference, 2.0%; 95% confidence interval, -2.7% to +6.7%) or objective (94.4% vs 96.7%; P = .50; difference, 2.3%; 95% confidence interval, -1.5% to +6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms. CONCLUSION MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months' follow-up in women without intrinsic sphincter deficiency.
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Affiliation(s)
- Joseph K-S Lee
- Department of Urogynecology, Mercy Hospital for Women, Heidelberg, VIC, Australia; Pelvic Floor Clinic, Monash Medical Center, Moorabbin, VIC, Australia; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia.
| | - Anna Rosamilia
- Pelvic Floor Clinic, Monash Medical Center, Moorabbin, VIC, Australia; Faculty of Medicine, Monash University, Melbourne, VIC, Australia
| | - Peter L Dwyer
- Department of Urogynecology, Mercy Hospital for Women, Heidelberg, VIC, Australia; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia
| | - Yik N Lim
- Department of Urogynecology, Mercy Hospital for Women, Heidelberg, VIC, Australia
| | - Reinhold Muller
- School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD, Australia
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Avoiding and Managing Complications of Synthetic Midurethral Slings. CURRENT BLADDER DYSFUNCTION REPORTS 2015. [DOI: 10.1007/s11884-015-0288-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
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Tommaselli GA, D’Afiero A, Di Carlo C, Formisano C, Fabozzi A, Nappi C. Tension-free vaginal tape-obturator and tension-free vaginal tape-Secur for the treatment of stress urinary incontinence: a 5-year follow-up randomized study. Eur J Obstet Gynecol Reprod Biol 2015; 185:151-5. [DOI: 10.1016/j.ejogrb.2014.12.012] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2014] [Revised: 12/15/2014] [Accepted: 12/18/2014] [Indexed: 11/26/2022]
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