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

Tieu, Aimee L.; Hegde, Aparna; Castillo, P.; Davila, G. Willy; Aguilar, Vivian C.

doi:10.1007/s00192-016-3128-z

Cited by 11 publications

(8 citation statements)

References 15 publications

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“…Data searches were performed in Google Scholar, PubMed, Medline, Embase, Scopus, Web of Science and the Cochrane Database of Systematic Reviews. Finally, 29 studies , including a total of 2 986 women, were selected for the meta‐analysis. An SIMS was defined as a midurethral sling placed through a single vaginal incision without skin incision, and included the Mini‐Arc, Contasure‐Needleless, Ophira, tissue fixation system (TFS) and Ajust.…”

Section: Methodsmentioning

confidence: 99%

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

Kim

Park

et al. 2018

BJU International

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The aim of the present paper was to assess and compare the long-term efficacy and safety of single-incision mini-slings (SIMSs), except tension-free vaginal tape (TVT)-Secur, with standard midurethral slings (SMUSs) for female stress urinary incontinence through an updated systematic review and meta-analysis of randomized controlled trials (RCTs) comparing these two surgical methods. A literature review of all RCTs comparing SIMSs (Mini-Arc, Contasure-Needleless, Ophira, Tissue Fixation System and Ajust), except TVT-Secur, with SMUSs was performed. The Medline, Embase, Scopus, Web of Science and Cochrane Controlled Trial Register databases were reviewed. We retrieved 29 RCTs (including a total of 2 986 patients) that compared SIMSs, except TVT-Secur, with SMUSs. Meta-analysis of long-term results showed no significant difference in the patient-reported cure rate (odds ratio [OR] 0.67, 95% confidence interval [CI] 0.44-1.60); however, we found that SMUSs had a significantly superior objective cure rate (OR 0.68, 95% CI 0.47-0.99; P = 0.04). SIMSs were associated with a significantly shorter operation time, lower immediate postoperative pain based on a visual analogue scale score, lower intra-operative blood loss, and lower postoperative voiding dysfunction. The meta-analysis showed clear evidence of the superiority of SMUSs over SIMSs, except TVT-Secur, in terms of the objective cure rate, after long-term follow-up; however, SIMSs were superior with respect to immediate postoperative pain, intra-operative blood loss, and postoperative voiding dysfunction.

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Section: Methodsmentioning

confidence: 99%

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

Kim

Park

et al. 2018

BJU International

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“…The 55 articles were summarized chronologically in Table 1 with detailed information on study design, intervention and comparator, measurements of reported complications and follow-up duration that were listed by the following order: RCT, systematic review/meta-analysis and review [11–65] …”

Section: Resultsmentioning

confidence: 99%

“…[69] Women who develop post-surgical OAB and feel worse than their pre surgical status should be carefully evaluated. Palos et al, [11] [12] [13] 2018 RCT SI-MUS 84 TVT-O 41 18 mo Palpable mesh fiber on anterior vaginal wall in SI group (2.4%), else not mentioned Pascom et al, [14] [15] 2018 RCT TOT 75 36 mo Reintervention 5.2% Unintentional perforation 5.2% Post voiding residual 1% Dyspareunia 0% Tieu et al, [16] 2017 RCT TOT 42 12 mo De novo urgency 0.7% Repeat SUI surgery 12% Vaginal mesh exposure 6.1% Fernandez et al, [17] [20] 2016 RCT TVT 93 TOT 83 60 mo Vaginal mesh exposure TVT 2%, TOT 7% Urine retention requiring intervention TVT 6%, TOT 4% Substantial pain TVT 21%, TOT 10% Schellart et al, [21] TVT-O 0%, SI 0% Jurakova et al, [23] Vaginal tape erosion TVT-O 0%, SI 0% Gaber et al, [24] Martinez et al, [25] [26] 2015 RCT TOT 103 12 mo Repeat surgery 1.8% Groin pain 6.2% Tommaselli et al, [27] Laurikainen et al, [28] Nyyssönen et al, [29] 2014 RCT TVT 50 TOT 50 46 mo De novo urgency TVT 3%-25%%, TOT 6%-25% Scheiner et al, [30] [32] [33] 2014 RCT TVT 30 12 mo Bladder perforation 2.9% Djehdian et al, [34] [35] 2014 RCT TOT 87 12 mo UTI 4.2% Reoperation 3.1% Bladder retention 1% Wadie et al, [36] Basu et al, [37] 2013 RCT TVT 33 36 mo Repeat continence procedure 0% SUI symptoms 9% Mostafa et al, [38] [39] No postoperative urinary retention Schierlitz et al, [40]…”

Section: Discussionmentioning

confidence: 99%

Focusing on long-term complications of mid-urethral slings among women with stress urinary incontinence as a patient safety improvement measure

et al. 2021

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Background: There are 3 different types of mid-urethral sling, retropubic, transobturator and single incision performed for women with stress urinary incontinence. Prior studies comparing these three surgeries merely focused on the successful rate or efficacy. But nevertheless, what is more clinically important dwells upon investigating postoperative complications as a safety improvement measure. Methods: A systematic review via PubMed, Ovid, and the Cochrane Database of Systematic Review and studies were applied based on the contents with clearly identified complications. Selected articles were reviewed in scrutiny by 2 individuals to ascertain whether they fulfilled the inclusion criteria: complications measures were clearly defined; data were extracted on study design, perioperative complications, postoperative lower urinary tract symptoms, postoperative pain, dyspareunia, and other specified late complications. Results: A total of 55 studies were included in the systemic review. Perioperative complications encompassed bladder perforation, vaginal injury, hemorrhage, hematoma, urinary tract infection. There were postoperative lower urinary tract symptoms including urine retention and de novo urgency. Furthermore, postoperative pain, tape erosion/ extrusion, further stress urinary incontinence surgery, and rarely, deep vein thrombosis and injury of inferior epigastric vessels were also reported. Conclusions: Complications of mid-urethral sling are higher than previously thought and it is important to follow up on their long-term outcomes; future research should not neglect to address this issue as a means to improve patient safety.

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“…Previous studies were small, heterogeneous and at high risk of bias. [153][154][155][156][157][158][159] l Schellart et al 137 randomised 97 participants to the SIMS MiniArc and 96 participants to the SMUS Monarc (TO-TVT). At 1 year, the patient-reported (PGI-I scale) success rates were 83% and 86% (p = 0.46) for the MiniArc and Monarc groups, respectively, and the objective (CST) success rates were 89% and 91% (p = 0.65) for the MiniArc and Monarc groups, respectively.…”

Section: The Patient Global Impression Of Improvement Scalementioning

confidence: 99%

“…185 In the literature, 20 RCTs (n = 2613 participants) compared SIMSs with SMUSs with regard to LUT injuries. 86,90,138,141,154,155,157,158,160,162,164,[189][190][191][192][193][194][195][196][197] Pooled data favoured neither SIMSs nor SMUSs (RR 0.69, 95% CI 0.35 to 1.36).…”

Section: Intraoperative Injuriesmentioning

confidence: 99%

Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT

Abdel‐Fattah

Cooper

Davidson

et al. 2022

Health Technol Assess

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

Abstract: The SI sling provides comparable objective efficacy to the TO sling at 1 year.

Cited by 11 publications

References 15 publications

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

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

Focusing on long-term complications of mid-urethral slings among women with stress urinary incontinence as a patient safety improvement measure

Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT

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