Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent.

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.

Long-term outcomes of Altis® single-incision sling procedure for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: In women with predominant stress urinary incontinence (SUI), recent data are still controversial regarding the short-term outcomes of mini-slings and there is a lack of evidence about the outcomes in the long term. Our aim was to evaluate the long-term effectiveness and complication rates of Altis® (Coloplast). METHODS: A total of 145 women with clinical SUI were implanted with an Altis® sling between April 2012 and December 2015. Women completed the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) before the intervention and in the following consultations. A telephone interview was performed in January 2021 and 131 women (90%) were available for re-evaluation. The main outcome was treatment success, defined as no self-reported SUI symptoms and no reintervention. Secondary outcomes included response to ICIQ-SF (cure defined as ICIQ-SF = 0) and Patient Global Impression of Improvement (PGI-I) questionnaires, de novo overactive bladder (OAB) symptoms and adverse events. RESULTS: The overall treatment success was 73.3% at a median follow-up of 8 years. The ICIQ-SF cure rate was 66.1%. In the PGI-I, 70.4% answered that they were much better or very much better. Later postoperative complications included 2 cases (1.5%) of vaginal extrusion (requiring surgical removal of the eroded mesh segment), 3 (2.3%) cases of infravesical obstruction (which led to sling section), de novo urgency in 20 patients (15.3%), and mild dyspareunia in 2 (1.5%) patients. CONCLUSIONS: The Altis® sling was safe and effective in a long-term follow-up, improving the quality of life in patients with SUI.

Comparison of Clinical Efficacy and Urodynamic Changes Using Single-incision Slings (MiniArc® vs. Solyx™) for the Treatment of Female Stress Urinary Incontinence.

OBJECTIVE: To compare the clinical efficacy and urodynamic parameter changes between the MiniArc and the Solyx sling for the treatment of female urodynamic stress incontinence (USI). MATERIALS AND METHODS: One-hundred and thirty (MiniArc n = 79, BS-Solyx n = 51) patients were included in this study. Cough stress test (ST), pad test (PT), Incontinence Impact short form Questionnaire (IIQ-7), Urogenital Distress Inventory six-item questionnaire (UDI-6), Sexual Questionnaire-Short Form (PIS-Q), and urodynamic parametric changes were assessed to determine objective and subjective outcomes following the procedure. Objective cure was defined as negative ST and PT <2 g and subjective cure was defined as "No" to the answer of UDI-6 Question #3. Predictors of surgical failure were also determined. RESULTS: All Solyx users, as opposed to 91.1% of MiniArc patients, obtained objective cure at postoperative 3 months (P = 0.042). No significant difference in subjective cure rates (93.7% vs. 90.2% at 3-months (P = 0.513); 89.9% vs. 80.4% at 1 year for Solyx and MiniArc patients, respectively (P = 0.126)) and improvement scores in UDI-6 and IIQ-7 were observed. The Solyx group incurred more de novo urgency (17.6% vs. 6.3% at 3 months (P = 0.042); 23.5% vs. 7.6% at 1 year (P = 0.01)). Both procedures yielded significant decrements in maximal urethral closure pressure (P < 0.001) and average flow rate (P = 0.015). The preoperative PT and sling type were strong predictors of surgical failure, where the Solyx tape reported lower odds (odds ratio = 0.174, P = 0.02) compared to the MiniArc sling. CONCLUSION: Single-incision mini-slings are safe and effective treatment for female USI. The Solyx SIS demonstrated superiority over the MiniArc in this study based on its higher objective cure rate and lower risk for surgical failure.

Comparison of 2 single incision slings on the vagina in an ovine model.

BACKGROUND: Stress urinary incontinence carries a significant healthcare burden for women worldwide. Single incision slings are minimally invasive mesh devices designed to treat stress urinary incontinence. For prolapse repair, meshes with higher porosity and lower structural stiffness have been associated with improved outcomes. OBJECTIVE: In this study, we compared the higher stiffness, lower porosity Altis sling with the lower stiffness, higher porosity Solyx sling in an ovine model. We hypothesized that SIS-B would have a negative impact on the host response. STUDY DESIGN: A total of Altis and Solyx single incision slings were implanted suburethrally into sheep according to the manufacturer's instructions on minimal tension. The mesh-urethral-vaginal complex and adjacent ungrafted vagina (no mesh control) were harvested en bloc at 3 months. Masson's trichrome and picrosirius red staining of 6 µm thin sections was performed to measure interfiber distance and tissue integration. Smooth muscle contractility to a 120 mM KCl stimulus was performed in an organ bath to measure myofiber-driven contractions. Standard biochemical assays were used to quantify glycosaminoglycan, total collagen, and elastin content, and collagen subtypes. Bending stiffness was performed in response to a uniaxial force to define susceptibility to folding/buckling. Statistical analysis was performed using Mann-Whitney, Gabriel's pairwise post hoc, Wilcoxon matched-pairs, and chi-square tests. RESULTS: The animals had similar ages (3-5 years), parity (multiparous), and weights (45-72 kg). Trichrome cross sections showed that the Altis sling buckled in a "C" or "S" shape in most samples (8 of 11), whereas buckling after Solyx sling implantation was observed in only a single sample (1 of 13; P=.004). Tissue integration, as measured by the presence of collagen or smooth muscle between the mesh fibers on trichrome 4× imaging, was increased in samples implanted with the Solyx sling compared with the Altis sling (P<.05). Total collagen content decreased significantly with both products when compared with the ungrafted vagina consistent with stress shielding. There was no difference in the 2 groups with regard to glycosaminoglycan or elastin content. The Altis sling mesh tissue complex demonstrated significantly higher amounts of both collagen types I and III than the Solyx sling-implanted tissue and the ungrafted control. Smooth muscle contractility in response to 120 mM KCl was decreased after implantation of both slings compared with the sham (P=.011 and P<.01), with no difference between mesh types (P=.099). Bending stiffness in the Altis sling was more than 4 times lower than in the Solyx, indicating an increased propensity to buckle (0.0186 vs 0.0883). CONCLUSION: The structurally stiffer Altis sling had decreased tissue integration and increased propensity to buckle after implantation. Increased collagen types I and III after the implantation of this device suggests that these changes may be associated with a fibrotic response. In contrast, the Solyx sling largely maintained a flat configuration and had improved tissue integration. The deformation of the Altis sling is not an intended effect and is likely caused by its lower bending stiffness. Both meshes induced a decrease in collagen content and smooth muscle contractility similar to previous findings for prolapse meshes and consistent with stress shielding. The long-term impact of buckling warrants further investigation.

Is the fixation of single incision TVT-S tape as good as that of transobturator tape? An ultrasound study of randomized trial results.

INTRODUCTION: TVT-Secur (TVT-S) was the first single-incision sling available on the market and was soon found to have less efficacy than mid-urethral slings. Our aim was to assess the position and tape descent following TVT-O and TVT-S H in a U procedure and, based on this evaluation, to find the possible reason for lower TVT-S surgery efficacy. METHODS: We conducted an ultrasound study of a randomised trial with a 3-year follow-up that took place between 2007 and 2009 and included 197 women with urodynamic stress urinary incontinence. Of these, 67 were allocated to receive the TVT-O procedure, 64 to TVT-S in the H position, and 65 in the U position. Patients underwent a complete urogynaecological and ultrasound examination. The positions of the bladder neck and the tape after surgery were assessed and the data obtained compared between groups. RESULTS: Our primary study showed a significantly higher rate of positive stress tests in the TVT-S groups compared to the TVT-O group. After surgery, there was no difference between the position of the tape at rest and at maximal Valsalva between the groups. In TVT-O patients, the mean length of the upper tape margin descent increased from 6 mm on the 1st day after surgery to 9 mm 3 months after surgery and remained stable afterwards. For TVT-S patients, there was a further increase of up to 15 mm in tape descent after 3 months. CONCLUSIONS: Our results show that the lower efficacy of TVT-S might be due to inadequate fixation and increasing tape descent.

Mini-Slings: Do They Stand the Test of Time? A 10-Year Cohort.

INTRODUCTION: It is known that failures after midurethral slings increase with the follow-up time. Nevertheless, data concerning mini-slings are sparse. To clarify this statement, we analyze a mini-sling cohort with a median follow-up of 10 years. Although the brand used, MiniArc®, is no longer available, an identical device, Solyx™, can still be used, which makes the analysis of the cohort clinically relevant. MATERIAL AND METHODS: A total of 172 women with predominant stress urinary incontinence (SUI) were consecutively treated with the mini-sling MiniArc® from 2006 until 2013. They were reevaluated in 2018. The primary outcome, treatment success, was defined as no self-reported SUI symptoms and no reintervention. Secondary outcomes included the response to patient-reported outcomes. Adverse events were assessed. RESULTS: After a median follow-up time of 113 months, 115 (66.9%) women were available for reevaluation. Forty-four (38.3%) women self-reported SUI. Seventeen women had been reoperated, 14 (12.2%) due to the reappearance of SUI and 3 due to complications. Altogether, MiniArc® had an overall success rate of 47.0% at 10 years. Among those not reoperated, 63.3% stated that they were much better or very much better in Patient Global Impression of Improvement (PGI-I) and 71.4% affirmed that their continence problem was normal or mild in Patient Global Impression of Severity (PGI-S). Almost 85% would repeat the surgery. Reoperation due to complications was rare (2.6%). De novo urgency appeared in 30.6% of the patients and it was managed with anticholinergic drugs with favorable outcomes. DISCUSSION/CONCLUSION: This report adds evidence to the long-term outcomes of mini-slings, confirming that they can cure or improve SUI and give patients high satisfaction rates, at the expense of low morbidity.

The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial.

INTRODUCTION: Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up. METHODS AND ANALYSIS: A pragmatic, multicentre, non-inferiority randomised controlled trial. PRIMARY OUTCOME MEASURE: The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months. SECONDARY OUTCOME MEASURES: The secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit. STATISTICAL ANALYSIS: The statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly. ETHICS AND DISSEMINATION: The North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations. TRIAL REGISTRATION NUMBER: ISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

Transobturator versus single incision slings: 1-year results of a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: To compare 1-year surgical outcomes following transobturator (TO) sling placement and single incision (SI) sling placement for the treatment of stress urinary incontinence (SUI). METHODS: We performed a randomized trial at a single institution. Patients with urodynamically proven SUI were offered participation and randomized to placement of a TO sling (Monarc™) or a SI sling (MiniArc™) between 2008 and 2011. The primary outcome measure was urinary leakage during standardized cough stress test (CST). Forty subjects in each group were required to achieve 80 % power to detect an effect size of 0.25. RESULTS: A total of 98 patients were randomized with 49 patients in the TO group and 49 patients in the SI group. Preoperative demographics were similar between the groups (Table 1). The TO group had a significantly longer sling operative time (10.7 ± 4.8 min vs. 7.8 ± 4.9 min, p < 0.001) and greater estimated blood loss (31.6 ± 26.6 mL vs. 22.9 ± 22.1 mL, p = 0.02). At the 1-year follow-up, there was no difference in the primary outcome with 9 TO patients (21 %) and 12 SI patients (29 %) having a positive CST (p = 0.5). A composite measurement of 'failure', defined as patient-reported SUI and a positive CST, showed no difference between the TO group (17 %) and the SI group (27 %; p = 0.3). CONCLUSIONS: The SI sling provides comparable objective efficacy to the TO sling at 1 year.