A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up. METHODS: This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student's t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure. RESULTS: We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference -0.6%, 95% CI -12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI -9 to 11%). Both procedures were associated with low complication rates. CONCLUSIONS: After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure.

Are patients willing to trade cure rate against less pain? Patients' preferences for single incision midurethral sling or transobturator standard midurethral sling.

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.

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.

AIMS: To compare efficacy and safety of two commercially available single incision slings (SIS) and trans-obturator vaginal tapes (TOT), namely MiniArc™ and Monarc™ slings, and report the results at 5-year follow-up. METHODS: A retrospective-observational study of prospectively collected data was conducted on 381 women with primary stress urinary incontinence (SUI) in a single tertiary referral center. Patients treated with MiniArc™ and Monarc™ were compared. Data regarding intraoperative and post-operative outcomes were collected and compared. Kaplan-Meier analyses assessed continence rate (CR), objective cure (OC) rate, de novo overactive bladder symptoms (OAB), surgical failure (SF), and erosion free rates at 1-, 3-, and 5-year follow-up. The log-rank test was used to compare efficacy and complication between patients stratified according to the type of surgery. RESULTS: Median follow-up was 60 months. Of 381 patients, 215 (56%) were treated with Monarc™ slings and 166 (44%) with MiniArc™. The two groups were homogeneous in terms of pre-operative characteristics. At 5-year follow-up, no difference was found in CR between Monarc™ and Miniarc™ patients (87% vs. 89%; P = 0.41). Monarc™ showed better OAB free rates (97% vs. 92%; P = 0.012). No significant differences have been found in terms of SF, erosion, and OC rates. These results are limited by their retrospective nature. CONCLUSIONS: We demonstrated that the short-term results of MiniArc™, are maintained over time, defining the comparability of the two slings at 5 years in terms of subjective and objective outcomes and complications. Neurourol. Urodynam. 36:803-807, 2017. © 2016 Wiley Periodicals, Inc.

A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up.

INTRODUCTION AND HYPOTHESIS: Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up. METHODS: We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals. RESULTS: We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR -5; 95% CI -0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR -1; 95% CI -0.10 to 0.07). Both procedures have low complication rates. CONCLUSIONS: At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated.

Variation in the practice of laparoscopic sacrohysteropexy and laparoscopic sacrocolpopexy for the treatment of pelvic organ prolapse: a Dutch survey.

INTRODUCTION AND HYPOTHESIS: Laparoscopic techniques for pelvic organ prolapse surgery using mesh are gaining interest. A standard approach or published guideline for the laparoscopic sacrohysteropexy (LSH) or laparoscopic sacrocolpopexy (LSC) is lacking. The purpose of this study is to assess the variation between Dutch gynecologists in executing LSH and LSC. METHODS: A questionnaire was developed to evaluate the technique of LSH and LSC. All members of the Dutch Society for Gynecological Endoscopy and Minimally Invasive Surgery and the Dutch Society for Urogynecology were invited by email to participate in a web-based survey. RESULTS: With 357 respondents, the response rate was 71%. Of the respondents, a total of 49 gynecologists (13.7%) perform LSH and/or LSC. Gynecologists who perform both procedures use the same surgical technique for LSH and LSC. There are variations among gynecologists on several key points such as the level of dissection along the anterior and posterior walls of the vagina, the type of mesh used, the type of sutures used, the tension of the implanted mesh and reperitonealization of the mesh. CONCLUSIONS: There is a high practice variation in LSH and LSC performed by a selected group of Dutch gynecologists. Different methods have been described in the literature and there is no consensus on how to perform these procedures. A well-designed prospective study or randomized controlled trial with regard to the specific parts of these procedures is needed to provide evidence for the best surgical technique. The outcomes of these studies will help to establish evidence-based guidelines.

A randomized comparison of a single-incision midurethral sling and a transobturator midurethral sling in women with stress urinary incontinence: results of 12-mo follow-up.

BACKGROUND: Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc). OBJECTIVE: To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0-100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain. RESULTS AND LIMITATIONS: We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p=0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p=0.65). The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p<0.01). CONCLUSIONS: At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain. PATIENT SUMMARY: This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.

Surgery versus physiotherapy for stress urinary incontinence.

BACKGROUND: Physiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy. METHODS: We performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months. RESULTS: We randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery. CONCLUSIONS: For women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.).