Standard Midurethral Slings Research Articles

Evaluating the use of real-time data collection using SMS texts in the SIMS study

Background A recent innovation in Patient Reported Outcomes (PROs) collection is the use of SMS texts. Results from a large randomised controlled trial (RCT) found this realtime data collection was both feasible and acceptable. As part of the multicentre NIHR HTA funded SIMS study (Adjustable Anchored Single-Incision Mini-Slings Versus Standard Tension-Free Mid-Urethral Slings in the Surgical Management Of Female Stress Urinary Incontinence; A Pragmatic Multicentre Non-Inferiority Randomised Controlled Trial), we evaluated responses to a post-surgery pain diary comparing PROs collected via texts and paper. The study raised several interesting data collection.

Incontinence-specific quality of life measures used in trials of sling procedures for female stress urinary incontinence: a meta-analysis.

We conducted this review to summarize the short-term and long-term efficacy of several midurethral sling procedures on quality of life (QoL) improvement based on incontinence-specific QoL measures in clinical trials among women with stress urinary incontinence (SUI). We searched MEDLINE (January 1966 to March 2015), EMBASE (January 1988 to March 2015), and the Cochrane Incontinence Group Specialised Register (March 2015). Only randomized controlled trials (RCTs) were eligible in this analysis. We identified 13 different condition-specific instruments in the included 31 RCTs; the Urogenital Distress Inventory (UDI), the Incontinence Impact Questionnaire (IIQ), and Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-12 (PISQ-12) were the most frequently used methods to measure QoL among women with SUI. We found that the improvement in sexual function (as assessed by PISQ-12) score was significantly higher in the single-incision slings group than in the TO-TVT group (WMD 1.06; 95 % CI 0.58-1.54); the post-operative pain visual analogue scale scores in the single-incision slings group was significantly lower than that in the TO-TVT group (WMD -1.59; 95 % CI -2.28 to -0.89). TO-TVT-treated patients had significantly greater reductions in total UDI scores (WMD 2.28; 95 % CI 1.77-2.80) and total IIQ scores (WMD 0.89; 95 % CI 0.26-1.52) than TVT-treated patients. The reduction in the total UDI score was significantly higher in the RP-TVT group than in the TO-TVT group (WMD -1.00; 95 % CI -1.65 to -0.35). Subgroup analysis of the total UDI score showed a significantly greater improvement in TO-TVT-treated patients than in TVT after long-term follow-up (>30 months), but no differences were detected after short-term follow-up (12-15 or 6 months). Our meta-analysis indicated that consistent use of the UDI and IIQ with or without the PISQ-12 might promote options for comparisons between trials. Single-incision slings were associated with significantly higher improvement in sexual function and lower post-operative pain compared with standard midurethral slings, and the long-term efficacy of TO-TVT was superior to the TVT procedure in terms of reducing the distress caused by incontinence symptoms.

Short-term outcomes of adjustable single-incision sling (Ajust™) procedure for stress urinary incontinence: a prospective single-center study

ObjectivesSlings have become the most widely performed surgical procedure for stress urinary incontinence (SUI) in last two decades. As the third generation sling, the efficacy of the early single-incision mini-sling was controversial. The aim of this study was to determine whether the new adjustable single-incision sling (Ajust™) is safe and effective in management of female SUI at 6–18 months follow-up. Study design69 patients with SUI according the inclusion and exclusion criteria were considered adjustable single-incision sling (Ajust™) from September 2012 to September 2013. 67 patients finished 6–18 months follow-up. The data about clinical parameter, operation, complication, Urogenital Distress Inventory-Short Form (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7) and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) in Chinese were collected in preoperative, 6-month and 12-month follow-up. ResultsAll patients underwent successful adjustable single-incision sling (AjustTM) placement. The subjective cure rate and objective cure rate was 82.0%, 92.5% in 6-month follow-up and 82.3%, 91.2% in 12-month follow-up respectively. There were no significant perioperative complications such as bladder perforation, major bleeding requiring blood transfusion in the present study. Sling exposure was observed in two patients (3.2%). ConclusionsAdjustable single-incision sling (AjustTM) was a safe and effective option for treating female SUI and was associated with comparable subjective and objective success rates when compared to standard midurethral slings (TVT-O) at a 6–18 months follow-up.

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

BackgroundMidurethral 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). ObjectiveTo compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS. Design, setting, and participantsProspective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible. Outcome measurements and statistical analysisPrimary 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 limitationsWe 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). ConclusionsAt 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain. Patient summaryThis 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.

Single-incision sling operations for urinary incontinence in women.

Single-incision sling operations for urinary incontinence in women.

Comparison of an adjustable anchored single‐incision mini‐sling, Ajust®, with a standard mid‐urethral sling, TVT‐OTM: a health economic evaluation

To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust(®) , C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O™, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence. A total of 137 women, in a secondary care setting, were randomized between October 2009 and October 2011 to undergo SIMS placement (n = 69) under local anaesthesia as an opt-out policy or SMUS placement (n = 68) under general anaesthesia. Clinical outcome measures included the patient-reported success rate (Patient Global Impression of Improvement [PGI-I]) and the impact on the patients' QoL (King's Health Questionnaire [KHQ]). Health economic data (cost and quality-adjusted life year [QALY] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness. There were no significant differences between the groups in terms of the KHQ total score (P = 0.27) or the patient-reported success rate (P = 1.00, odds ratio: 0.895; 95% confidence interval [CI]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: -0.003; 95% CI: -0.008 to +0.002). The SIMS was on average less costly, -£142.41 95% CI: (-316.99 to 32.17) and generated cost savings of £48 419 per QALY loss with 94% probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group (P = 0.006, 95% CI: 11.756 to 17.217), there was an increase in cost savings to -£477, (95% CI: -823.65 to -129.63), with a probability of 100% of cost savings to the wider economy. The adjustable anchored SIMS (Ajust), performed under local anaesthesia as an opt-out policy, delivers cost savings to the health service provider when compared with the SMUS (TVT-O), and is likely to be cost-effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow-up and should explore patient preferences alongside an adequately powered non-inferiority randomized controlled trial.

Multicenter Prospective Randomized Study of Single-incision Mini-sling Vs Tension-free Vaginal Tape-obturator in Management of Female Stress Urinary Incontinence: A Minimum of 1-Year Follow-up

To compare an adjustable anchored single incision mini-sling (SIMS-Ajust) vs tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence (SUI) with a minimum of 1-year follow-up. We conducted a multicenter prospective randomized control trial (RCT) performed in 6 United Kingdom centers in the period between October 2009 and October 2011. Women were randomized to either SIMS-Ajust (C. R. Bard) performed under local anesthesia or TVT-O (Ethicon Inc.) performed under general anesthesia. Women completed validated symptom-severity and quality of life (QOL) questionnaires preoperatively and at 1 year. In addition, women completed the Patient Global Impression of Improvement (PGI-I) and underwent the Cough Stress Test (CST) at 1 year. The primary outcome at 12 months was the patient-reported success rate. Secondary outcomes included objective cure, reoperation rate, impact on women's urinary symptoms, QOL, and sexual function. Data was analyzed using SPSS-19 with significance level set at 5%. One hundred thirty-seven women were randomized into 2 groups: the SIMS-Ajust group (n=69) and the TVT-O group (n= 68). At 1 year, there were no significant differences in the patient-reported success rate (odds ratio [OR] 0.895, 95% confidence interval [CI] 0.344-2.330, P= 1.000), objectives success rate (OR 0.929, 95% CI 0.382-2.258, P= 1.00), and reoperation rates (OR 0.591, 95% CI 0.136-2.576, P= .721) between the SIMS-Ajust and the TVT-O groups, respectively. A comparable number of women reported cure/improvement of urgency (P= .658), significant improvement in QOL (P= .190), and sexual function (P= .699) in both groups. Adjustable-anchored SIMS (Ajust) is associated with comparable patient-reported and objective success rates when compared to standard midurethral sling (SMUS, TVT-O) at a minimum of 1-year follow-up. The results should be interpreted with caution due to the relatively small cohort size. Long-term follow-up of this RCT is required to ascertain the durability of these results.

A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes

To compare the postoperative pain profile, peri-operative details, and short-term patient-reported and objective success rates of single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS). In a multicentre prospective randomised trial in six UK centres in the period between October 2009 and October 2010, 137 women were randomised to either adjustable SIMS (Ajust®, C. R. Bard Inc., NJ, USA), performed under local anaesthesia as an opt-out policy (n=69), or SMUS (TVT-O™, Ethicon Inc., Somerville, USA) performed under general anaesthesia (n=68). Randomisation was done through number-allocation software and using telephone randomisation. Postoperative pain profile (primary outcome) was assessed on a ten-point visual analogue scale at fixed time-points. Pre- and post operatively (4-6 months) women completed symptom severity, urgency perception scale (UPS), quality of life and sexual function questionnaires. In addition, women completed a Patient Global Impression of Improvement Questionnaire and underwent a cough stress test at 4-6 months follow up. Sample size calculation was performed and data were analysed using SPSS 18. Descriptive analyses are given and between-group comparisons were performed using chi-square, Fischer exact test and Mann-Whitney test as appropriate. Significance level was set at 5%. Women in the SIMS Ajust® group had a significantly lower postoperative pain profile up to 4 weeks (p=<0.001, 95% CI 1.151, 2.480). There was no significant difference in peri-operative complications between groups. All 137 women completed the 4-6 months follow-up. Patient-reported and objective cure rates were not significantly different: 85.5% versus 91.2% (p=0.443) and 90% versus 97% (p=0.165) between the SIMS Ajust® and TVT-O™ groups respectively. There was a trend towards higher rates of de novo urgency or worsening of pre-existing urgency in the SIMS Ajust® group (21.7% versus 8.8%) but this did not reach statistical significance (p=0.063). Women in the SIMS Ajust® group had shorter hospital stay (median (IQR) 3.65 (2.49, 4.96)) compared to (4.42 (3.16, 5.56)) the TVT-O™ group 95% CI (-0.026, 1.326), with significantly earlier return to normal activities (p=0.025) and to work (p=0.006). The adjustable single-incision mini-sling (Ajust®) is associated with a significantly improved postoperative pain profile and earlier return to work when compared to standard mid-urethral slings (TVT-O™), with encouraging results in patient-reported and objective success rates at short-term follow-up.

Single-Incision Mini-Slings Versus Standard Midurethral Slings in Surgical Management of Female Stress Urinary Incontinence: A Meta-Analysis of Effectiveness and Complications

Single-Incision Mini-Slings Versus Standard Midurethral Slings in Surgical Management of Female Stress Urinary Incontinence: A Meta-Analysis of Effectiveness and Complications

Slings in surgery of genuine stress incontinence

To summarize the available evidence concerning efficacy and safety of standard mid-urethral sling (SMUS) operations for the treatment of stress urinary incontinence (SUI). A non-systematic literature review was carried out in order to collect the available evidence concerning efficacy and safety of SMUS operations for the treatment of SUI. According to the data of our prior meta-analysis, patients receiving SMUS had significantly higher overall and objective cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations. Patients undergoing SMUS and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms and had a higher reoperation rate. Patients treated with retropubic SMUS had slightly higher objective cure rates than those treated with transobturator tape (TOT); however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of some complications. Meta-analysis demonstrated similar outcomes for TOTs. With regard to the novel mini-sling, another meta-analysis from Abdel-fattah et al. demonstrated that repeat continence surgery and de novo urgency incontinence were significantly higher in the patients treated with mini-slings. Patients treated with retropubic tape (RT) experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective. The use of RT was followed by objective cure rates slightly higher than TOT and by higher risk of complications. The novel mini-slings do not seem to be more effective than the SMUS.