Single-incision needleless mini-sling technique for female stress urinary incontinence: A comparative study with standard transobturator inside-out technique
https://doi.org/10.4081/aiua.2023.11342
Accepted: April 30, 2023
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
To evaluate the safety and efficacy of surgeon-tailored polypropylene mesh (STM) through a needle-less single incision mini-slings (SIMS) vs. standard trans-obturator tape (TOT) in the treatment of female stress urinary incontinence (SUI). Methods: We conducted an open-label randomized controlled trial that included women with SUI. Eligible women were randomized in a 1:1 ratio to receive either standard TOT or SIMS techniques. All procedures were performed using a surgeon-tailored polypropylene mesh and monofilament tape. Results: A total of 60 women were included. The mean operative time was significantly longer in the standard TOT group. The mean bleeding rate was significantly higher in the standard TOT group (87.6 ± 10.6 cc) compared to the SIMS group (60.0 ± 8.1 cc). There was no urethral injury in both groups. Transient thigh pain occurs in 12 cases (40 %) of the standard TOT and no cases in the SIMS group (p < 0.001). After three months, there was no significant statistical difference between the result of the two groups as regard to cure or improvement rate. No failed cases were reported in both groups (p = 0.64). Likewise, there was no significant difference between the two groups regarding patients' satisfaction rate. Conclusions: SIMS was not inferior to standard TOT. STM SIMS is a mini-invasive, relatively safe, reproducible, easy to perform in a short time, with excellent patient tolerability and minimal pain, allowing early return to work and economically effective surgical procedure for the treatment of female stress urinary incontinence.
Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004; 6(Suppl 3):S3-S9.
Aoki Y, Brown HW, Brubaker L, et al. Urinary incontinence in women. Nat Rev Dis Prim. 2017; 3:17042.
Reynolds W, Dmochowski R, Penson D. Epidemiology of Stress Urinary Incontinence in Women. Curr Urol Rep. 2011;12:370-376.
Shirvan MK, Rahimi HR, Darabi Mahboub MR, Sheikhi Z. Tension-free vaginal tape versus transobturator tape for treatment of stress urinary incontinence: A comparative randomized clinical trial study. Urol Sci. 2014; 25:54-57.
Hasan MRA, AbdelMagid ME, Tagreda IA. Sub-urethral Mini Sling versus Transobturator Vaginal Tape for Treatment of Female Stress Urinary Incontinence, One Year Follow-up. Egypt J Hosp Med. 2019; 76:3176-3183.
Nerli RB, Kumar AG, Koura A, et al. Transobturator vaginal tape in comparison to tension-free vaginal tape: A prospective trial with a minimum 12 months follow-up. Indian J Urol. 2009; 25:321-325.
Zyczkowski M, Nowakowski K, Kuczmik W, et al. Tension-free vaginal tape, transobturator tape, and own modification of transobturator tape in the treatment of female stress urinary incontinence: comparative analysis. Biomed Res Int. 2014;347856.
Rajamaheshwari N, Varghese L. Transobturator tapes are preferable over transvaginal tapes for the management of female stress urinary incontinence: For. Indian J Urol. 2009; 25:550-553.
Gomes CM, Carvalho FL, Bellucci CHS, et al. Update on complications of synthetic suburethral slings. Int Braz J Urol. 2017; 43:822-834.
Khan FN, Hamid A, Wazir BS, et al. An Evaluation of Use of Trans-Obturator Tape (TOT) Sling Procedure in the Current Surgical Management of Female Stress Urinary Incontinence. Int J Health Sci (Qassim). 2008; 2:118-125.
Ford AA, Rogerson L, Cody JD, et al. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane database Syst Rev. 2017; 7:CD006375-CD006375.
Sergouniotis F, Jarlshammar B, Larsson P-G. Urethral complications after tension-free vaginal tape procedures: A surgical management case series. World J Nephrol. 2015; 4:396-405.
Wu E, High R, Lewis C, et al. Retropubic mid-urethral slings and de novo urinary urgency and frequency: The role of retropubic hematomas. Neurourol Urodyn. 2021; 40:1686-1694.
Leanza V, Intagliata E, Leanza A, et al. Comparison between three mini-sling surgical procedures and the traditional transobturator vaginal tape technique for female stress urinary incontinence. G Chir. 2014; 35:80-84.
Abdel-Fattah M, MacLennan G, Kilonzo M, et al. 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 con. BMJ Open. 2017;7:e015111-e015111.
JAVA. Declaration of Helsinki World Medical Association Declaration of Helsinki. Bull world Heal Organ. 2013; 79:373-374.
Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials (Chinese version). J Chinese Integr Med. 2010; 8:604-612.
Sand PK, Winkler H, Blackhurst DW, Culligan PJ. A prospective randomized study comparing modified Burch retropubic urethropexy and suburethral sling for treatment of genuine stress incontinence with low-pressure urethra. Am J Obstet Gynecol. 2000; 182:30-34.
Cabrera J, Puyol M, Sousa A, et al. Minimal invasive surgical technique without Needles. (Contasure Needleless) for the surgical treatment of stress urinary incontinence: a multicentric trial. Eur Urol Suppl - Eur Urol Suppl. 2008; 7:147.
Navazo R, Sierra J, Hidalgo C, et al. Contasure needleless: A single incision TOT for the surgical treatment of stress urinary incontinence. Arch Esp Urol. 2009; 62:719-723.
Magon N, Chopra S. Transobturator Tape in Treatment of Stress Urinary Incontinence: It is Time for a New Gold Standard. N Am J Med Sci. 2012; 4:226-230.
Dobson A, Robert M, Swaby C, et al. Trans-obturator surgery for stress urinary incontinence: 1 year follow-up of a cohort of 52 women. Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18:27-32.
Moore RD, JR M, M C. Monarc Transtobturator sling: Combined analysis of one-year followup in nine countries with 266 patients. Int Urogynecol J Pelvic Floor Dysfunct. 2006; 17:203-207.
Amati LT ME and LJ Contasure-Needleless® compared with transobturator-TVT® for the treatment of stress urinary incontinence. Int Urogynecol J. 2001; 22:827-33.
Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 2010; 362:2066-2076.
Karakeçi A, Eftal TC, Keles¸ A, et al. Single-incision midurethral sling shows less pain and similar success rate in a short-term followup compared to the transobturator tape method in the treatment of stress urinary incontinence. Turkish J Urol. 2020;46:63-68.
Maturana AP, Palos CC, Ghersel FR, et al. Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence. Int Urogynecol J. 2020;31:1925 1931.
Djehdian LM, Araujo MP, Takano CC, et al. Transobturator sling compared with single-incision mini sling for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2014; 123:553-561.
Pascom ALG, Djehdian LM, Bortolini MAT, et al. Randomized controlled trial comparing single incision mini-sling and transobturator midurethral sling for the treatment of stress urinary incontinence: 3-year follow-up results. Neurourol Urodyn. 2018; 37:2184-2190.
Sangsawang B, Sangsawang N. Stress urinary incontinence in pregnant women: a review of prevalence, pathophysiology, and treatment. Int Urogynecol J. 2013; 24:901-912.
de Vries AM, Heesakkers JPFA. Contemporary diagnostics and treatment options for female stress urinary incontinence. Asian J Urol. 2018; 5:141-148.
Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape). A new minimally invasive method in the treatment of urinary incontinence in women. Progr Urol. 2003; 13:656-659.
Deval B, Ferchaux J, Berry R, et al. Objective and subjective cure rates after trans-obturator tape (OBTAPE) treatment of female urinary incontinence. Eur Urol. 2006 49:373-377.
Copyright (c) 2023 the Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Downloads
Citations
