Single-incision sling operations for urinary incontinence in women
- PMID: 37888839
- PMCID: PMC10604512
- DOI: 10.1002/14651858.CD008709.pub4
Single-incision sling operations for urinary incontinence in women
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 Sixteen trials used TVT-Secur, a single-incision sling withdrawn from the market in 2013.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.
Trial registration: ClinicalTrials.gov NCT00534365 NCT00843908 NCT01095159 NCT00676273 NCT02506309 NCT00527696 NCT02540525 NCT01230450 NCT02599051 NCT01054833 NCT01384084 NCT02867748 NCT03052985 NCT01348334 NCT00751088 NCT03520114 NCT04586166 NCT01799122 NCT02263534 NCT03515109 NCT03916471 NCT05225168.
Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
In accordance with Cochrane's
EC: no conflicts of interest to declare.EEJ: is Assistant Managing Editor for Cochrane Incontinence. However, she did not take part in the editorial process for this review.MS: no conflicts of interest to declare.AB: no conflicts of interest to declare.ASA: no conflicts of interest to declare.PA: no conflicts of interest to declare.SJ: is an author of a study included in this review (Van Rensburg 2015). He did not take part in eligibility decisions, data extraction, or risk of bias and GRADE assessments.AN: no conflicts of interest to declare.
Cochrane’s Funding Arbiters have judged that previous versions of this review are not compliant with Cochrane’s Commercial Sponsorship Policy, specifically the clause ‘The lead author and more than 50% of all authors must not have received other types of financial support from an industry sponsor with an interest in the review’ (Nambiar 2017; Nambiar 2014). As declared in both versions of the review, this funding took the form of grants for travel to conferences and meetings.
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Update of
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Single-incision sling operations for urinary incontinence in women.Cochrane Database Syst Rev. 2017 Jul 26;7(7):CD008709. doi: 10.1002/14651858.CD008709.pub3. Cochrane Database Syst Rev. 2017. Update in: Cochrane Database Syst Rev. 2023 Oct 27;10:CD008709. doi: 10.1002/14651858.CD008709.pub4. PMID: 28746980 Free PMC article. Updated.
References
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Bianchi‐Ferraro 2013 {published data only}
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Elbadry 2017 {published data only (unpublished sought but not used)}
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Emami 2019 {published data only}
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Faber 2021 {published data only}
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Fernandez‐Gonzalez 2017 {published data only}
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Foote 2015 {published data only}
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Fu 2017 {published data only}
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Jurakova 2016 {published data only}
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Lee 2012 {published data only}
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Martoccia 2020 {published data only}
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- Martoccia A, Pastore AL, Al Salhi Y, Fuschi A, Velotti G, Capone L, et al. Tension-free transobturator suburethral tape versus single-incision sling: evaluation of sexual function and quality of life in women with stress urinary incontinence (Abstract number 31). Neurourology and Urodynamics 2020;39(Suppl 4):S49-50.
Masata 2012 {published data only}
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- Masata J, Martan A, Hubka P, Svabik K. Long-term follow up (with a minimum of five years) comparing the efficacy of TVT-O and TVT SECUR system in the treatment of stress urinary incontinent women- randomized trial (Abstract number 752). In: 46th Annual Meeting of the International Continence Society (ICS); 2016 Sep 13-16; Tokyo, Japan. 2016. [sr-incont73459]
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- Masata J, Svabik K, Drahoradova P, Hubka P, Zvara K, El-Haddad R, et al. Randomized prospective trial of a comparison of the efficacy of TVT-O and TVT Secur system in the treatment of stress urinary incontinent women comparison of the long- and short-term results (Abstract number 3). Neurourology and Urodynamics 2011;30(6):805-6. [sr-incont42163]
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- Masata J, Svabik K, Elhaddad R, Hubka P, Drahoradova P, Martan A. Randomized prospective trial of a comparison of the efficacy of TVT-O and TVT SECUR system in the treatment of stress urinary incontinent women - Long-term results (Abstract number 003). International Urogynecology Journal and Pelvic Floor Dysfunction 2011;22(Suppl 1):S3-4. [sr-incont62269]
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- Masata J, Svabik K, Hubka P, Elhaddad R, Drahoradova P, Martan A. What happens with single incision tape (TVT-S) after surgery, in comparison with TVT-O? an ultrasound study results from a randomized trial (Abstract number 23). International Urogynecology Journal and Pelvic Floor Dysfunction 2012;23(2 Suppl 1):S69-71. [sr-incont45468]
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- Masata J, Svabik K, Hubka P, Martan A. Randomized prospective trial of a comparison of the efficacy of TVT-O and TVT SECUR system in the treatment of stress urinary incontinent women-long-term results with a minimum of five years follow-up (Abstract number OP 108). International Urogynecology Journal and Pelvic Floor Dysfunction 2015;26(1 Suppl 1):S137-8. [sr-incont69596]
Masata 2016 {published data only}
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- Farhat F, Švabík K, Hubka P, Martan A, Mašata J. Ultrasound comparison of adjustable single-incision (Ajust) and transobturator tapes to assess post-operative fixation and function and clinical efficacy. Ceska Gynekologie 2016;81(5):324-35. [sr-incont74412] - PubMed
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- Masata J, Martan A, Svabik K, Hubka P, El Haddad R. Randomized trial of a comparison of the efficacy of TVT-O and single incision tape Ajust in the treatment of stress urinary incontinent women - one-year follow up (Abstract number PP 08). International Urogynecology Journal and Pelvic Floor Dysfunction 2014;25(1 Suppl 1):S9-S10. [sr-incont67462] - PubMed
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- Masata J, Svabik K, Hubka P, El Haddad R, Martan A. Randomized trial comparing the safety and peri-operative complications of transobturator introduced tension-free vaginal tape (TVT-O) and single-incision tape with adjustable length and anchoring mechanism (Ajust): three months results (Abstract number 188). Neurourology and Urodynamics 2013;32(6):783. [sr-incont49203]
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- Masata J, Svabik K, Hubka P, Elhaddad R, Martan A. Comparison of the safety and peri-operative complications of transobturator introduced tension-free vaginal tape (TVT-O) and single-incision tape with adjustable length and anchoring mechanism (Ajust) in a randomized trial: short term results (Abstract number 148). International Urogynecology Journal and Pelvic Floor Dysfunction 2013;24(1 Suppl 1):S114-5. [sr-incont62179]
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- Masata J, Svabik K, Hubka P, Martan A. Randomized trial to compare the efficacy of TVT-O and single incision tape ajust in the treatment of stress urinary incontinent women-two year follow-up (Abstract number 503). Neurourology and Urodynamics 2015;34(S3):S418-20.
Maslow 2014 {published data only}
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- Maslow K, Gupta C, Klippenstein P, Girouard L. Randomised clinical trial comparing TVT-Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence. International Urogynecology Journal 2014;25(7):909-14. [NCT00527696] [sr-incont62080] - PubMed
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- NCT00527696. Trial comparing TVT SECUR system and transvaginal obturator tape for surgical management of stress urinary incontinence [Randomized clinical trial comparing TVT SECUR system (TVT S) and trans vaginal obturator tape (TVT-O) for surgical management of stress urinary incontinence]. clinicaltrials.gov/ct2/show/NCT00527696 (first received 11 September 2007). [CRSREF: 3348021] [NCT00527696] [sr-incont42750]
Maturana 2019 {published data only}
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- Maturana AP, Palos CC, Ghersel FR, Fernandes CE, Oliveira E. Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence. International Urogynecology Journal 2019;31(9):1925-31. [DOI: 10.1007/s00192-019-04145-y] [NCT02540525] [sr-incont78662] - DOI - PubMed
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- NCT02540525. Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence [Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial]. clinicaltrials.gov/show/NCT02540525 (first received 4 September 2015). [NCT02540525] [sr-incont68787]
Melendez‐Munoz 2018 {published data only}
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- ACTRN12611001151921. Tension free vaginal tape (TVT) Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence—a randomised controlled trial [In female patients with Stress Urinary Incontinence, is MiniArc as good as Tension free vaginal Tape (TVT) Abbrevo in objective cure rates?]. anzctr.org.au/ACTRN12611001151921.aspx (first received 22 October 2011). [ACTRN12611001151921] [CRSREF: 3348025] [sr-incont43056]
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- Melendez-Munoz J, Braverman M, Rosamilia A, Young N, Leitch A, Lee J. Miniarc vs TVT Abbrevo midurethral sling in women with stress urinary incontinence - an RCT - 6 and 12 month follow up (Abstract number 718). Neurourology and Urodynamics 2017;36(3):S517-19. [ACTRN12611001151921] [sr-incont77508]
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- Melendez-Munoz J, Braverman M, Rosamilia A, Young NR, Leitch A, Lee JK. MiniArc vs TVT Abbrevo midurethral sling in women with stress urinary incontinence: an RCT. 6 and 12 month follow-up (Abstract number 021). International Urogynecology Journal 2017;28(1):S18-9. [ACTRN12611001151921] [sr-incont78124]
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- Melendez-Munoz J, Braverman M, Rosamilia A, Young, NR, Leitch A, Lee, J. TVT Abbrevo and MiniArc suburethral sling in women with stress urinary incontinence - a randomised controlled trial 6 months results (Abstract number OP 06). International Urogynecology Journal and Pelvic Floor Dysfunction 2016;27(1):S75-6. [ACTRN12611001151921] [sr-incont73434] - PubMed
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- Melendez-Munoz J, Braverman M, Rosmilia A, Young N, Leitch A, Lee JK. TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - a randomized controlled trial. European Journal of Obstetrics, Gynaecology and Reproductive Biology 2018;230:141-6. [ACTRN12611001151921] [sr-incont78125] - PubMed
Merali 2012 {published data only}
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- Merali S, Dolhaniuk C, Unger T. Stress incontinence in women: a pilot study comparing the Miniarc single incision sling system to the Monarc transobturator sling system. Journal of Minimally Invasive Gynecology 2012;19(Suppl 6):S33-4. [sr-incont62237]
Mostafa 2012 {published data only}
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- Boyers D, Kilonzo M, Mostafa A, Abdel-Fattah M. Comparison of an adjustable anchored single-incision mini-sling, Ajust(TM), with a standard mid-urethral sling, TVT-O(TM): a health economic evaluation. BJU International 2013;112(8):1169-77. [NCT01230450] [sr-incont49458] - PubMed
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- Boyers D, Kilonzo M, Mostafa A, Abdel-Fattah M. Single incision mini-slings versus standard mid-urethral slings in surgical management of female stress urinary incontinence: a cost-effectiveness analysis alongside a randomised controlled trial (Abstract number 2). Neurourology and Urodynamics 2012;31(6):726-7. [sr-incont45457]
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- Mostafa A, Agur W, Abdel-All M, Guerrero K, Allam M, Lim C. A multicentre randomised trial of single-incision mini-sling (AJUSTc) and tension-free vaginal tape-obturator (TVT-O™) in management of female stress urinary incontinence (Abstract number 4). Neurourology and Urodynamics 2011;30(6):806-8. [sr-incont42164]
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- Mostafa A, Agur W, Abdel-All M, Guerrero K, Lim C, Allam M, et al. A multicentre prospective randomised study of single-incision mini-sling (Ajust) versus tension-free vaginal tape-obturator (TVT-OTM) in the management of female stress urinary incontinence: pain profile and short-term outcomes. European Journal of Obstetrics, Gynecology and Reproductive Biology 2012;165(1):115-21. [sr-incont45867] - PubMed
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- Mostafa A, Agur W, Abdel-All M, Guerrero K, Lim C, Allam M, et al. 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. Urology 2013;82(3):552-9. [NCT01230450] [sr-incont48534] - PubMed
Oliveira 2011 {published data only}
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- Lopes T, Resende A, Oliveira R, Pinto R, Botelho F, Tomada N, et al. Sexual function impact of stress urinary incontinence surgical treatment: Comparison between midurethral and single-incision slings (Abstract). Journal of Sexual Medicine 2011;8(Suppl 5):390. [sr-incont62291]
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- Oliveira R, Botelho F, Silva P, Resende A, Silva C, Dinis P, et al. Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up. European Urology 2011;59(6):940-4. [sr-incont41493] - PubMed
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- Resende A, Oliveira R, Botelho F, Silva C, Dinis P, Cruz F. Randomized trial comparing a conventional mid-urethral sling and two single-incision slings: mid-term evaluation (Abstract number UP-01.078). Urology 2011;78(3 Suppl 1):S211. [sr-incont62232]
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- Santos Oliveira R, Botelho F, Silva P, Silva CM, Dinis P, Cruz FJ. Randomized clinical trial comparing TVT-O™, TVT-Secur™ and Mini-Arc™. Outcome at 12 months follow-up (Abstract number 391). European Urology Supplements 2010;9(2):145. [sr-incont41579]
Ow 2019 {published data only}
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- ACTRN12616000328471. Comparison of the mini sling or retropubic sling in the treatment of women with severe (Intrinsic Sphincter Deficiency -ISD) stress urinary incontinence (SUI) [Objective cure rate of mini sling or retropubic sling in women with Intrinsic Sphincter Deficiency - a RCT study (Mini RISD)]. anzctr.org.au/ACTRN12616000328471.aspx (first received 29 February 2016). [ACTRN12616000328471] [sr-incont71376]
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- Ow LL, Lee JK, Lim YN, Leitch A, Murray C, Dwyer PL, et al. Mini or retropubic sling in women with intrinsic sphincter deficiency-an RCT (mini RISD) (Abstract number: short oral 76). Female Pelvic Medicine and Reconstructive Surgery 2019;25(5):S65.
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- Ow LL, Lee L, Lim YN, Leitch A, Murray C, Dwyer P, et al. Mini or retropubic sling in women with Intrinsic Sphincter Deficiency -- an RCT (Mini RISD). Australian and New Zealand Continence Journal 2018;24(3):83-5.
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- Ow LL, Murray C, Alexander J, Lee J, Leitch A, Dwyer P, et al. Mini or retropubic sling in women with intrinsic sphincter deficiency at 6 months- an RCT (MINI RISD) (Abstract number: short oral 127). Female Pelvic Medicine and Reconstructive Surgery 2022;28(6 Suppl 1):S74.
Pascom 2018 {published data only}
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- Djehdian L, Araujo M, Takano C, Del Roy C, Castro R, Sartori MG, et al. Randomised trial of Ophira mini-sling system and unitape for the treatment of stress incontinence in women. First experiences after a follow-up of 6 months. (Abstract number 768). In: Joint Meeting of the International Continence Society (ICS) and the International Urogynecological Association; 2010 Aug 23-27; Toronto, Canada. 2010. [sr-incont40201]
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- Djehdian L, Araujo M, Takano CC, Del-Roy CA, Sartori MG, Girão MJ, et al. Transobturator sling compared with single-incision mini sling for the treatment of stress urinary incontinence: a randomized controlled trial. Obstetrics and Gynecology 2014;123(3):553-61. [NCT01094353] [sr-incont60507] - PubMed
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- Djehdian LM, Araujo M, Takano C, Del-Roy C, Sartori M, Girao M, et al. Randomised trial of Ophira mini-sling system and Unitape transobturator suburethral sling for the treatment of stress urinary incontinence in women (Abstract number 254). International Urogynecology Journal and Pelvic Floor Dysfunction 2011;22(Suppl 3):S1814-6. [NCT01094353] [sr-incont62230]
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- NCT01094353. A comparative study minisling versus transobturator (TOT) sling (SUI) [Randomised trial of Ophira™ minisling system and Unitape™ for the treatment of stress urinary incontinence in women]. clinicaltrials.gov/show/NCT01094353 (first received 26 March 2010). [NCT01094353] [sr-incont62913]
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- Pascom AL, Castro RA, Bortolini MA, Sartori MM, Girao MB, Jarmy-Di Bella ZI. Randomized controlled trial comparing Ophira® and Unitape T Plus® for the treatment of stress urinary incontinence: 3-year results (Abstract number OP 05). International Urogynecology Journal and Pelvic Floor Dysfunction 2016;27(1):S74-5. [sr-incont73435]
Pastore 2016 {published data only}
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- Al Salhi Y, Pastore AL, Palleschi G, Riganelli L, Autieri D, Fuschi A, et al. Evaluation of sexual function and quality of life in women treated for stress urinary incontinence: tension-free transobturator suburethral tape vs. single incision sling (Abstract number 49). Neurourology and Urodynamics 2016;35:S49. [sr-incont75564] - PubMed
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- Pastore AL, Palleschi G, Al SY, Riganelli L, Fuschi A, Autieri D, et al. Evaluation of sexual function and quality of life in women treated for stress urinary incontinence: tension-free transobturator suburethral tape versus single-incision sling. Journal of Women's Health 2016;25(4):355-9. [sr-incont72067] - PubMed
Radwan 2020 {published data only}
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- Radwan A, Higazy A, Metwally M, Mousa W, Kandil M, Gamal MA. Single-incision mid-urethral mini slings versus standard transobturator slings in management of women with stress urinary incontinence: a randomized controlled trial. Egyptian Journal of Surgery 2020;39(4):920-5.
Ross 2014 {published data only}
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- NCT00685217. Transvaginal tape (TVT) Secur versus TVT randomised controlled trial (RCT) [Tension-free vaginal tape management of stress incontinence in women: randomized trial of TVT Secur versus TVT]. clinicaltrials.gov/ct2/show/NCT00685217 (first received 28 May 2008). [NCT00685217] [sr-incont43064]
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- Ross S, Tang S, Schulz J, Murphy M, Goncalves J, Kaye S, et al. Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial. BMC Research Notes 2014;7:941. [NCT00685217] [sr-incont66440] - PMC - PubMed
Rudnicki 2017 {published data only}
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- Alexandridis V, Rudnicki M, Jakobsson U, Teleman P. Adjustable mini-sling compared to conventional mid-urethral slings in women with urinary incontinence. 3-year follow-up of a randomized controlled trial (Abstract number 241). Neurourology and Urodynamics 2018;37:S184-5. [NCT01754558] [sr-incont78106]
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- Arenholt LT, Glavind K, Rudnicki M, Teleman P. Monarc and Ajust for treatment of urinary stress incontinence-ultrasonic evaluation and subjective cure (Abstract). Female Pelvic Medicine and Reconstructive Surgery 2014;20:S350. [NCT01754558] [sr-incont72527]
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- NCT01754558. One year outcome using the Ajust system for treatment of urinary stress incontinence. clinicaltrials.gov/show/NCT01754558 (first received 21 December 2012). [NCT01754558] [sr-incont62918]
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- Rudnicki M, Jakobsson U, Teleman P, Group SA. One-year comparison of an single incision mini sling and conventional midurethral slings. A randomized controlled study (Abstract number 520). In: 46th Annual Meeting of the International Continence Society (ICS); 2016 Sep 13-16; Tokyo, Japan. 2016. [NCT01754558] [sr-incont73456]
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- Rudnicki M, Jakobsson U, Teleman P. Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial. International Urogynecology Journal 2020;31(8):1545-50. - PubMed
Sabadell 2017 {published data only}
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- NCT01699425. Multicentric comparative randomized study of the single-incision sling Ajust® versus suburethral transobturator slings. clinicaltrials.gov/show/NCT01699425 (first received 3 October 2012). [NCT01699425] [sr-incont62924]
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- Sabadell J, Palau-Gene M, Huguet E, Montero-Armengol A, Salicru S, Poza JL. Multicentre randomized trial of the AjustTM single-incision sling compared to the Align™ transobturator tape sling. International Urogynecology Journal 2017;28(7):1041-7. [NCT01699425] [sr-incont75475] - PubMed
Saleh 2020 {published data only}
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- Saleh A, Ghareb M, Ibrahiem D, Elnagar W, Barakat M. Needleless Contasure versus TVT-O in women with stress urinary incontinence. Open Journal of Obstetrics and Gynecology 2020;10(8):1107-21.
Schellart 2014 {published data only}
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- Roovers J, Schellart R, Van Der Aa F. A randomized comparison of single incision mid-urethral sling (MINIARC™) and transobturator mid-urethral sling (MONARC™) for treatment of stress urinary incontinence: 2-year clinical outcomes (Abstract number OP3). Journal of Minimally Invasive Gynecology 2015;22(3):S2. [NL3617 (NTR3783)] [sr-incont75734]
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- Roovers J-P, Schellart RP, Kimpe B, Lucot J-P, De Ridder D, Rengerink KO. A randomized comparison of single incision midurethral sling (MiniArc™) and transobturator midurethral sling (Monarc) for treatment of stress urinary incontinence: 2-year clinical outcomes (Abstract number: Podium #44). Neurourology and Urodynamics 2015;34:S95. [NL3617 (NTR3783)] [sr-incont68569]
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- Schellart RP, Casteleijn FM, Dijkgraaf MG, Tutolo M, Roovers JW. Are patients willing to trade cure rate against less pain? Patients' preferences for single incision midurethral sling or transobturator standard midurethral sling. Neurourology and Urodynamics 2017;36(4):1187-93. [sr-incont73603] - PubMed
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- Schellart RP, De Ridder D, Kimpe B, Lucot JP, Van der Aa F, Ruiter L, et al. A randomized comparison of single incision midurethral sling (Miniarc) and transobturator mid-urethral sling (Monarc) in women with stress urinary incontinence (Abstract number 140). International Urogynecology Journal and Pelvic Floor Dysfunction 2013;24:S107-8. [NL3617 (NTR3783)] [sr-incont62183]
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- Schellart RP, Dijkgraaf MG, Van der Aa F, Lucot J, Kimpe B, De Ridder D, et al. A randomized comparison of single incision mid-urethral sling (MiniArc) and transobturator mid-urethral sling (Monarc) for treatment of stress urinary incontinence: 2-year clinical outcomes (Abstract number: OP 079). International Urogynecology Journal and Pelvic Floor Dysfunction 2014;25(1):S158-9. [NL3617 (NTR3783)] [sr-incont64337]
Schweitzer 2015 {published data only}
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- Schweitzer KJ, Cromheecke GJ, Milani AL, Van Eijndhoven HW, Gietelink D, Hallenleben E. A randomised controlled trial comparing the TVT-O® with the Ajust® as primary surgical treatment of female stress urinary incontinence (Abstract number 32). International Urogynecology Journal 2012;23(Suppl 2):S77-8. [NL2288 (NTR2558)] [sr-incont45467]
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- Schweitzer KJ, Milani AL, Van Eijndhoven HW, Gietelink DA, Hallensleben E, Cromheecke GJ, et al. Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial. Obstetrics and Gynecology 2015;125(1):27-34. [NL2288 (NTR2558)] [sr-incont66395] - PubMed
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- Schweitzer KJ. A randomised controlled trial comparing the TVT-O® with the Ajust® as primary surgical treatment of female stress urinary incontinence. trialregister.nl/trial/2288 (first received 10 June 2010). [NL2288 (NTR2558)] [sr-incont43057]
Seo 2012 {published data only}
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- Lee WK, Kwon JB, Seo JH, Seo HJ, Kim JY, Lee JW, Kim GN. A prospective randomized comparative study between tension free vaginal tape inside out and suburethral single incision sling for the treatment of female stress urinary incontinence: 24 month follow up (Abstract number 173). European Urology Supplements 2012;11(1):e173-173a. [sr-incont62252]
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- Seo JH, Kim GN, Kim JY, Seo HJ, Lee JW, Lee WG. Comparison between transobturator vaginal tape inside out and single incision sling system in the treatment of female stress urinary incontinence: prospective randomized study (Abstract number 23). Neurourology and Urodynamics 2011;30(6):832. [sr-incont42169]
Sharifiaghdas 2015 {published data only}
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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 Medical Report 2015;116(3):210-8. [sr-incont69267] - PubMed
Shawky 2015 {published data only}
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- Shawky H, Mahmoud M, Mohammed H, Khalifa E, Mahran A. TVT-secur versus TVT-obturator: a randomized trial of suburethral sling operative procedures for stress urinary incontinence, el Minia experience (Abstract number P1007). International Journal of Gynecology and Obstetrics 2015;131:E597. [sr-incont72571]
Sivaslioglu 2012 {published data only}
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- Sivaslioglu AA, Unlubilgin E, Aydogmus S, Celen E, Dolen I. A prospective randomized comparison of transobturator tape and tissue fixation system minisling in 80 patient with stress urinary incontinence 5 year results. Journal of Urology 2012;188(1):194-9. [sr-incont43318] - PubMed
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- Sivaslioglu AA, Unlubilgin E, Aydogmus S, Celen E, Dolen I. A prospective randomized comparison of transobturator tape and tissue fixation system minisling in 80 patient with stress urinary incontinence—3 year results. Pelviperineology 2010;29(2):56-9. [sr-incont43317]
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- Sivaslioglu AA, Unlubilgin E, Dolen I, Kaplan M. The comparison of tissue fixation (TFS) system with transobturator tape (TOT) in the treatment of stress urinary incontinence (Abstract number 61). International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18(Suppl 1):S36-7. [sr-incont27327]
Smith 2017 {published data only}
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- NCT02599051. Transobturator versus single incision slings [Transobturator versus single incision slings: 1 year results of a randomized control trial]. clinicaltrials.gov/show/NCT02599051 (first received 6 November 2015). [NCT02599051] [sr-incont69679]
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- Smith AL, Castillo P, Karp D, Davila GW, Aguilar V. Transobturator vs. single incision sling in women with stress urinary incontinence: a prospective randomized controlled trial (Abstract number: poster 158). Female Pelvic Medicine and Reconstructive Surgery 2011;17(5):S170-1. [NCT02599051] [sr-incont71152]
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- Smith AL, Castillo P, Karp D, Gross C, Davila G, Aguilar VC. Transobturator versus single incision slings in women with stress urinary incontinence: a prospective randomised controlled trial (Abstract presentation number 52). International Urogynecology Journal and Pelvic Floor Dysfunction 2011;22:S54-5. [NCT02599051] [sr-incont45303]
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- Tieu AL, Hegde A, Castillo PA, Davila G, Aguilar V. Transobturator versus single incision slings in women with stress urinary incontinence: 1-year results of a randomized controlled trial (Abstract number: poster 145). Female Pelvic Medicine and Reconstructive Surgery 2013;19:S158-9. [NCT02599051] [sr-incont72781]
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- Tieu AL, Hegde A, Castillo PA, Davila GW, Aguilar VC. Transobturator versus single incision slings in women with stress urinary incontinence: 1 year results of a randomized controlled trial (Abstract number 142). International Urogynecology Journal and Pelvic Floor Dysfunction 2013;24:S109-10. [NCT02599051] [sr-incont62181] - PubMed
Sottner 2012 {published data only}
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- Sottner O, Halaska M, Maxova K, Vlacil J, Kolarik D, Hurt K. Comparison of three different midurethral slings in the treatment of female urinary incontinence in institutionalized elderly patients (Abstract number 859). In: 43rd Annual Meeting of the International Continence Society (ICS); 2013 Aug 26-30; Barcelona, Spain. 2013. [sr-incont60037]
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- Sottner O, Halaška M, Vláčil J, Maxová K, Malá I, Krombholz R, et al. A comparison of different types of suburethral slings in the treatment of urinary incontinence in geriatric patients. Ceska Gynekologie 2012;77(5):403-7. [sr-incont45893] - PubMed
Tang 2014 {published data only}
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- ChiCTR-IPR-15006967. A RCT of TVT-O and TVT-S in the treatment of stress urinary incontinence. chictr.org.cn/showproj.aspx?proj=11725 (first received 25 August 2015). [ChiCTR-IPR-15006967] [sr-incont68802]
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- Sun Z, Wang X, Lang J, Xu T, Zhang Y, Kang J, et al. Comparison of outcomes between single-incision sling and transobturator sling for treating stress urinary incontinence: a 10-year prospective study. Neurourology and Urodynamics 2019;38(7):1852-8. [ChiCTR‐IPR‐15006967] [sr-incont78670] - PubMed
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- Tang X, Zhu L, Liang S, Lang J. Outcome and sexual function after transobturator tape procedure versus tension-free vaginal tape SECUR: a randomized controlled trial. Menopause 2014;21(6):641-5. [sr-incont62113] - PubMed
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- Zhu L, Tang X, Liang S. Coital incontinence in urogynecologic patients: incidence and risk factors (Abstract number: NDP0278). Female Pelvic Medicine and Reconstructive Surgery 2014;20:S296-7. [sr-incont75022]
Tommaselli 2010 {published data only}
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- Tommaselli GA, D'Afiero A, Di CC, Formisano C, Fabozzi A, Nappi C. Tension-free vaginal tape-O and -Secur for the treatment of stress urinary incontinence: a thirty-six-month follow-up single-blind, double-arm, randomized study. Journal of Minimally Invasive Gynecology 2013;20(2):198-204. [sr-incont47549] - PubMed
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- Tommaselli GA, D'Afiero A, Di CC, 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. European Journal of Obstetrics, Gynecology, and Reproductive Biology 2015;185:151-5. [sr-incont66448] - PubMed
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- Tommaselli GA, D'Afiero A, Formisano C, Fabozzi A, Di CC, Nappi C. Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: three years follow-up (Abstract number O691). International Journal of Gynecology and Obstetrics 2012;119(Suppl 3):S503-4. [sr-incont62239]
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- Tommaselli GA, D'Afiero A, Formisano C, Fabozzi A, Di Carlo C, Nappi C. Ultrasonographic evaluation of the positioning of TVT-O vs. TVT-Secur and their effect on the urethra: an ancillary analysis of a 36-months follow-up randomized study (Abstract number 187). Neurourology and Urodynamics 2013;32(6):781-2. [sr-incont49204]
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- Tommaselli GA, Di Carlo C, Gargano V, Formisano C, Scala M, Nappi C. Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1-year follow-up. International Urogynecology Journal 2010;21(10):1211-7. [sr-incont40921] - PubMed
Van Rensburg 2015 {published data only}
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- Van Rensburg JA, Jeffery ST, Sand Enbergh HA, Juul L, Steyn DW. Single incision-needleless and inside out TVT-O: a multicentre clinical equivalent randomised trial with preliminary 6 months and one year outcome for stress urine continence (Abstract number OP 107). International Urogynecology Journal and Pelvic Floor Dysfunction 2015;26(1 Suppl 1):S136-7. [sr-incont69597]
Wang 2011 {published data only}
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- Wang YJ, Li FP, Wang Q, Yang S, Cai XG, Chen YH. Comparison of three mid-urethral tension-free tapes (TVT, TVT-O, and TVT-Secur) in the treatment of female stress urinary incontinence: 1-year follow-up. International Urogynecology Journal 2011;22(11):1369-74. [sr-incont42639] - PubMed
Xin 2016 {published data only}
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- Xin X, Song Y, Xia Z. A comparison between adjustable single-incision sling and tension-free vaginal tape-obturator in treating stress urinary incontinence. Archives of Gynecology and Obstetrics 2016;293(2):457-63. [sr-incont70513] - PubMed
Yoon 2011 {published data only}
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- Yoon H, Lee DH, Kim YJ. Early results of comparison of Contasure-needleless™ and TOT outside-in midurethral slings (Abstract number 852). In: 41st Annual Meeting of the International Continence Society (ICS); 2011 Aug 29 to Sep 2; Glasgow, Scotland. 2011. [sr-incont42238]
References to studies excluded from this review
Ahn 2014 {published data only}
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- Ahn JH, Chung HS. Comparison of single-incision mid-urethral tape (Ophira™) and transobturator tape (Safyre™) suburethraral sling procedures for female stress urinary incontinence (Abstract number 263). In: 44th Annual Meeting of the International Continence Society (ICS); 2014 Oct 20-24; Rio de Janeiro, Brazil. 2014. [sr-incont64742]
Araco 2011 {published data only}
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- Araco F, Gravante G, Sorge R, Overton J, Castrì F, Primicerio M, et al. Sedation with local versus general anesthesia for the tension-free vaginal tape Secur hammock procedure. International Journal of Gynaecology and Obstetrics 2011;113(2):108-11. [sr-incont41545] - PubMed
Castañeda 2014 {published data only}
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- Castañeda E, Sanz-Granda Á, Hidalgo A, Meza DF, Marqueta JM, Carreras M. Cost-effectiveness analysis of surgical management of stress urinary incontinence with single-incision mini-sling versus tension-free vaginal obturator in Spain (Abstract number PIH26). Value In Health 2014;17(7):A509. [DOI: 10.1016/j.jval.2014.08.1556] - DOI - PubMed
De Leval 2011 {published data only}
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- De Leval J, Thomas A, Waltregny D. The original versus a modified inside-out transobturator procedure: 1-year results of a prospective randomized trial. International Urogynecology Journal 2011;22(2):145-56. [ISRCTN65635093] [sr-incont40993] - PubMed
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Dogan 2018b {published data only}
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- Dogan O, Basbug A, Kaya AE, Pulatoglu C, Yassa M. A randomized prospective comparison of the needleless mini-sling "hammock" and "U-shape" configurations for management of stress urinary incontinence: 18 month follow-up results. Archives of Gynecology and Obstetrics 2018;297(6):1483-93. [sr-incont78137] - PubMed
Feng 2018 {published data only}
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- Feng S, Luo D, Liu Q, Yang T, Du C, Li H, et al. Three- and twelve-month follow-up outcomes of TVT-EXACT and TVT-ABBREVO for treatment of female stress urinary incontinence: a randomized clinical trial. World Journal of Urology 2018;36(3):459-65. [ChiCTR-IOR-17011788] [sr-incont78118] - PubMed
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- Luo D, Shen H. Comparison of the efficacy and safety of TVT-EXACT vs TVT-ABBREVO in the treatment of female stress urinary incontinence. www.chictr.org.cn/showproj.aspx?proj=20086 (first received 29 June 2017). [ChiCTR-IOR-17011788] [sr-incont76204]
Lee JS 2010 {published data only}
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- Lee JS, Kim JH, Kim JH, Seo JT. One-year surgical outcomes and quality of life in minimally invasive slings for the treatment of female stress urinary incontinence: TVT SECUR™ vs. CureMesh™ (Abstract number 806). In: Joint Meeting of the International Continence Society (ICS) and the International Urogynecological Association; 2010 Aug 23-27; Toronto, Canada. 2010. [sr-incont40203]
Lee KS 2010 {published data only}
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- Lee HN, Cho WJ, Han J-Y, Choo M-S, Lee K-S. Randomized comparative study of the U- and H-type approaches of the TVT-Secur™ procedure for the treatment of female stress urinary incontinence: two-year follow-up (Abstract) (Poster number NM7). Neurourology and Urodynamics 2011;30(2):259. [sr-incont41375]
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- Lee HN, Lee S-W, Lee Y-S, Lee SY, Lee K-S. Tension-free vaginal tape-SECUR procedure for the treatment of female stress urinary incontinence: 3-year follow-up results. Lower Urinary Tract Symptoms 2015;7(1):9-16. [sr-incont67395] - PubMed
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- Lee HN, Lee Y, Cho WJ, Lee HS, Lee K. Randomized, comparative study of the U- and H-type approaches of the TVT-Secur™ procedure for the treatment of female stress urinary incontinence: two-year follow-up (Abstract number 849). In: 41st Annual Meeting of the International Continence Society (ICS); 2011 Aug 29 to Sep 2; Glasgow, Scotland. 2011. [sr-incont42733]
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- Lee K, Lee Y, Seo JT, Na YG, Seo JH, Lee JG. A prospective multicenter randomized study of 'U' and 'H' approach of TVT-SECUR procedure for the treatment of female stress urinary incontinence: one-year follow-up (Abstract number 5). Neurourology and Urodynamics 2009;28(7):587-8. [sr-incont35633]
Lian 2020 {published data only}
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- Lian PH, Ji ZG, Li HZ, Xiao H, Yan WG, Huang ZM. Intraoperative vaginal perforation during various mid-urethral sling procedures treating female stress urinary incontinence. Journal of Investigative Surgery 2020;33(3):203-10. [sr-incont78665] - PubMed
Liapis 2010 {published data only}
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- Liapis A, Bakas P, Creatsas G. Comparison of the TVT SECUR System "Hammock" and "U" tape positions for management of stress urinary incontinence. International Journal of Gynecology and Obstetrics 2010;111(3):233-6. [sr-incont42524] - PubMed
Martan 2008 {published data only}
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- Martan A, Svabík K, Masata J, Koleska T, El Haddad R, Pavlikova M. The solution of stress urinary incontinence in women by the TVT-S surgical method—correlation between the curative effect of this method and changes in ultrasound findings. Ceska Gynekologie 2008;73(5):271-7. [sr-incont29223] - PubMed
Martan 2011 {published data only}
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- Krhut J, Martan A, Gartner M, Zachoval R, Svabik K, Halaska M, et al. The comparison of the results of mini-invasive treatment of stress urinary incontinence using AJUST and MiniArc system [Srovnání výsledků miniinvazivní léčby ženské stresové inkontinence metodou Ajust a MiniArc]. Ceska Urologie 2012;16(1):20-8. [sr-incont78166]
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- Martan A, Masata J, Svabik K, Halaska M, Zachoval R, Horcicka L, et al. Evaluation of experience with MiniArc and Ajust system mini-sling anti-incontinence procedures, considering changes in the cure rate over time (Abstract number 165). International Urogynecology Journal 2012;23(Suppl 2):S217-8. [sr-incont45464]
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- Martan A, Masata J, Svabik K, Halaska M, Zachoval R, Horcicka L. Evaluation of experience with Miniarc and Ajust system mini-sling anti-incontinence procedures (Abstract number 4). Neurourology and Urodynamics 2012;31(6):729-30. [sr-incont45304]
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- Martan A, Svabík K, Halaska M, Zachoval R, Horcicka L, Krhut J. Evaluation of initial experience with safety and short efficacy of mini-sling antiincontinence procedures MiniArc and AJUST system. Ceska Gynekologie 2011;76(5):349-55. [sr-incont43009] - PubMed
Melon 2022 {published data only}
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- Melon J, Karjalainen PK, McGannon C, Lee JK, Rosamilia A. Medium-term clinical efficacy and safety of single incision and modified trans-obturator mid-urethral slings for female stress urinary incontinence. Gynecology and Obstetrics Clinical Medicine 2022;2(2):57-62. [DOI: 10.1016/j.gocm.2022.04.004] - DOI
NCT01054833 {published data only}
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- NCT01054833. Clinical evaluation of the Needleless® Sling [A clinical evaluation of the Needleless® sling for the treatment of female stress urinary incontinence]. ClinicalTrials.gov/show/NCT01054833 (first received 22 January 2010). [NCT01054833] [sr-incont42755]
NCT01384084 {published data only}
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- NCT01384084. Pelvic organ prolapse repair plus mini-sling versus pelvic organ prolapse repair alone [Urinary incontinence and uro-genital prolapse: a randomized trial of pelvic organ prolapse repair plus mini-sling versus pelvic organ prolapse repair alone]. clinicaltrials.gov/ct2/show/NCT01384084 (first received 8 June 2011). [NCT01384084] [sr-incont45469]
NCT02867748 {published data only}
-
- NCT02867748. TVT-ABBREVO versus SERASIS for the treatment of female urinary stress incontinence: 1 year outcomes of a comparative study with 2 trans-obturator sub mid urethral slings. clinicaltrials.gov/show/NCT02867748 (first received 16 August 2016). [NCT02867748] [sr-incont73344]
NCT03052985 {published data only}
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- NCT03052985. Materiovigilance after urinary incontinence or prolapse surgery (VIGI-MESH) [Observatory of materiovigilance after surgery of urinary incontinence or prolapse in women]. clinicaltrials.gov/show/NCT03052985 (first received 14 February 2017). [NCT03052985] [sr-incont76209]
Okulu 2011 {published data only}
-
- NCT01348334. Synthetic mesh materials in sling surgery [Use of three types of synthetic mesh materials in sling surgery: a prospective randomized clinical trial evaluating effectiveness and complications]. ClinicalTrials.gov/show/NCT01348334 (first received 5 May 2011). [NCT01348334] [sr-incont42756]
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- Okulu E, Kayigil O, Aldemir M, Onen E. The use of three types of synthetic mesh materials in the surgery for stress incontinence: the clinical results. International Urogynecology Journal and Pelvic Floor Dysfunction 2011;22(Suppl 2):S1024-5. [NCT01348334] [sr-incont62216]
Palomba 2012 {published data only}
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- NCT00751088. A randomized controlled study comparing three single-incision devices for female urinary stress incontinence [A comparison among three single-incision devices for the treatment of female urinary genuine stress incontinence: a randomized controlled study]. ClinicalTrials.gov/show/NCT00751088 (first received 11 September 2008). [NCT00751088] [sr-incont42746]
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- Palomba S, Falbo A, Oppedisano R, Torella M, Materazzo C, Maiorana A, et al. A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence. International Urogynecology Journal 2014;25(10):1333-41. [NCT00751088] [sr-incont63951] - PubMed
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- Palomba S, Oppedisano R, Torella M, Falbo A, Maiorana A, Materazzo C, et al. A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data. European Journal of Obstetrics Gynecology and Reproductive Biology 2012;163(1):108-12. [NCT00751088] [sr-incont44508] - PubMed
Palomba 2014 {published data only}
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- Palomba S, Oppedisano R, Falbo A, Torella M, Maiorana A, Materazzo C, et al. Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial. Journal of Minimally Invasive Gynecology 2014;21(2):303-10. [sr-incont60650] - PubMed
Pardo 2010 {published data only}
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- Pardo J, Solà V, Ricci P. Effectiveness of TVT-Secur compared with MiniArc for stress urinary incontinence: a randomized controlled trial with mini-sling (Abstract number 221). Neurourology and Urodynamics 2010;29(6):1126-7. [sr-incont40161]
Tommaselli 2012a {published data only}
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- Tommaselli GA, Formisano C, Di CC, Fabozzi A, Nappi C. Effects of a modified technique for TVT-O positioning on postoperative pain: single-blind randomized study. International Urogynecology Journal 2012;23(9):1293-9. [sr-incont45107] - PubMed
Tommaselli 2012b {published data only}
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- Tommaselli GA, D'Afiero A, Formisano C, Fabozzi A, Di CC, Nappi C. Comparison of TVT-O and TVT-Abbrevo for the surgical management of female stress urinary incontinence: a 12-months preliminary study (Abstract number O692). International Journal of Gynaecology and Obstetrics 2012;119:S504. [sr-incont65169]
Zullo 2020 {published data only}
References to studies awaiting assessment
Huser 2020 {published data only}
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- Huser M, Belkov I, Horvath I, Tvarozek S. Randomized controlled comparison of single-incision sling and transobturator midurethral sling for the treatment of stress urinary incontinence in long term: 5-year follow-up results (Abstract number 016). International Urogynecology Journal 2020;31(Suppl 1):S9.
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- Huser M, Hudecek R, Belkov I, Horvath I, Jarkovsky J, Tvarozek S. Long term safety and efficacy of single-incision sling versus mid-urethral sling in the treatment of stress urinary incontinence. Authorea 2020 March 17 [Preprint]. Available at www.authorea.com/doi/full/10.22541/au.158447897.77917186 (accessed 9 January 2023). [DOI: 10.22541/au.158447897.77917186] - DOI - PubMed
Pushkar 2011 {published data only}
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- Pushkar' DI, Kasian GR, Gvozdev MI, Lynova IL, Kupriianov IA. Mini-invasive operations for correction of urinary incontinence in females. Urologiia (Moscow, Russia) 2011;11(4):16-20. [sr-incont43390] - PubMed
References to ongoing studies
Matthews 2018 {published data only}
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- NCT03520114, Matthews C, Shuping J, Rardin CR. Retropubic vs. single-incision mid-urethral sling for stress urinary incontinence [Randomized trial of retropubic versus single-incision mid-urethral sling (Altis™) for concomitant management of stress urinary incontinence during native tissue vaginal repair]. clinicaltrials.gov/ct2/show/NCT03520114 (first received 9 May 201 8). [NCT03520114] [sr-incont78123]
Matthews 2020 {published data only}
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- Matthews CA, Vyas SN, Henley BR, Kenton K, Rosenblatt PL, Jeffrey S, et al. Single-incision versus retropubic mid-urethral sling (Solyx) for SUI during minimally invasive sacrocolpopexy [SASS: randomized trial of single-incision versus retropubic mid-urethral sling (Solyx) for concomitant management of stress urinary incontinence during minimally invasive sacrocolpopexy]. clinicaltrials.gov/show/NCT04586166 (first received 14 October 2020). [NCT04586166] [sr-incont89997]
NCT01799122 {published data only}
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- NCT01799122. Trial comparing Mini-Arc Precise Pro and the trans vaginal obturator tape for stress urinary incontinence [Randomized clinical trial comparing Mini-Arc Precise Pro and the trans vaginal obturator tape for surgical management of stress urinary incontinence]. clinicaltrials.gov/ct2/show/NCT01799122 (first received 26 February 2013). [NCT01799122] [sr-incont62915]
NCT02263534 {published data only}
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- NCT02263534. Comparing minisling to tension free vaginal tape in management of stress urinary incontinence [Randomized controlled trial comparing minisling to tension free vaginal tape in mangement of stress urinary incontinence]. clinicaltrials.gov/show/NCT02263534 (first received 13 October 2014). [NCT02263534] [sr-incont64746]
NCT03515109 {published data only}
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- NCT03515109. Prospective study of Altis System with the TVTO procedure for the management of stress urinary incontinence in women [Prospective randomized trial of Altis minisling with the TVTO transobturator tape procedure for the management of genuine stress urinaty incontinence in women]. clinicaltrials.gov/show/NCT03515109 (first received 3 May 2018). [NCT03515109] [sr-incont78127]
NCT03916471 {published data only}
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- NCT03916471. Comparison of efficacy and side effects between the Obtryx and Solyx band with 5-year follow-up [Comparison of efficacy and side effects between the Obtryx and Solyx band with 5-year follow-up. Prospective, randomized and non-inferiority study]. clinicaltrials.gov/show/NCT03916471 (first received 16 April 2019). [NCT03916471] [sr-incont78638]
NCT05225168 {published data only}
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- NCT05225168. Comparison of minisling suburethral sling and laparoscopic Buch [sic] colposuspension [Comparison of minisling suburethral sling use and laparoscopic Buch [sic] colposuspension application in terms of surgical efficacy and side effects in true stress urinary incontinence surgery]. clinicaltrials.gov/show/NCT05225168 (first received 4 February 2022). [NCT05225168] [sr-incont99121]
PACTR201607001696163 {published data only}
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- PACTR201607001696163. Modified needleless single-incision mini-sling [Modified needleless single-incision mini-sling compared to standard trans-obturator mid-urethral sling in the surgical management of female stress urinary incontinence]. pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1696 (first received 1 February 2013). [PACTR201607001696163] [sr-incont73367]
Shen 2015 {published data only}
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- Shen W, Fu J. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a prospective randomized controlled trail to evaluate the efficiency and safety. chictr.org.cn/showproj.aspx?proj=10638 (first received 16 March 2015). [ChiCTR-IOR-15006140] [sr-incont67571]
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Jeffery 2010b
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- Jeffery ST, De Jong P, Abdool Z, Van Wijk F, Lucente V, Murphy M. Single‐incision sling operations for urinary incontinence in women. Cochrane Database of Systematic Reviews 2010, Issue 9. Art. No: CD008709. [DOI: 10.1002/14651858.CD008709] - DOI
Nambiar 2014
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