Introduction and hypothesis
Stress urinary incontinence (SUI) is the involuntary loss of urine on effort and is a condition that negatively interferes with various aspects of a woman’s life. This study aimed to demonstrate the non-inferiority of the less invasive single-incision mini-sling (SIMS) method in objective and subjective cures in relation to tension-free transobturator tape (TOT) in two analyses, per protocol and intention to treat, and secondarily to evaluate complications and quality of life.
This study was a randomized controlled trial (RCT). Participants in this study included 105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity. Patients were evaluated pre- and postoperatively through anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6).
Regarding the objective cure, SIMS was non-inferior to TOT (p < 0.05). However, the same was not found for the subjective cure (p > 0.05). There were no differences in the complication rates (p > 0.05). However, in the TOT group, bladder perforation (2.4%), tape exposure (2.4%) and urinary retention occurred, lasting > 7 days (2.4%). In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05).
The non-inferiority of SIMS in relation to TOT was only demonstrated in the objective cure. There were no significant differences between groups regarding complications and quality of life.
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Haylen BT, de Ridder D, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21(1):5–26.
Karbage SAL, Santos ZMSA, Frota MA, et al. Quality of life of Brazilian women with urinary incontinence and impact on their sexual function. Eur J Obstet Gynecol Reprod Biol. 2016;201:56–60. https://doi.org/10.1016/j.ejogrb.2016.03.025.
Barentsen JA, Visser E, Hofstetter H, et al. Severity, not type, is the main predictor of decreased quality of life in elderly women with urinary incontinence: a population-based study as part of a randomized controlled trial in primary care. Health Qual Life Outcomes. 2012;10:153. https://doi.org/10.1186/1477-7525-10-153.
Wood LN, Anger JT. Urinary incontinence in women. BMJ. 2014;349:g4531. https://doi.org/10.1136/bmj.g4531.
Kowalik CG, Dmochowski RR, De EJB. Surgery for female SUI: the ICI algorithm. Neurourol Urodyn. 2019. https://doi.org/10.1002/nau.23879.
Petros PE, Ulmsten UI. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl. 1993;153:1–93.
Ulmsten U, Henriksson L, Johnson P, et al. An ambulatory surgical produce under local anestesia for treatment of female urinary incontinence. Int Urogynecol J. 1996;7:81–6.
Nilsson CG, Palva K, Rezapour M, et al. Eleven years prospective follow-up of TVT produce treatment of stress urinary incontinence. Int Urogynecol J. 2008;19:1043–7.
Deng DY, Rutman M, Raz S, et al. Presentation and management of major complications of midurethral slings: are complications under-reported? Neurourol Urodyn. 2007;26:46–52.
Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol. 2001;11(6):1306–13.
de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003;44:724–30.
Seklehner S, Laudano MA, Xie D, et al. A meta-analysis of the performance of retropubic mid urethral slings versus transobturator mid urethral slings. J Urol. 2015;193(3):909–15. https://doi.org/10.1016/j.juro.2014.09.104.
Cox A, Herschorn S, Lee L. Surgical management of female SUI: is there a gold standard? Nat Rev Urol. 2013;10(2):78–9. https://doi.org/10.1038/nrurol.2012.243.
Ford AA, Rogerson L, Cody JD, et al (2017) Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 7:CD006375. https://doi.org/10.1002/14651858.CD006375.pub4.
Molden SM, Lucente VR. New minimally invasive slings: TVT Secur. Curr Urol Rep. 2008;9:356–61.
Palma P, Riccetto C, et al. What is the best indication for single-incision Ophira mini sling? Insights from a 2-year follow-up international multicentric study. Int Urogynecol J. 2014;25(5):637–43.
Wu WY, Sheu BC, Lin HH. Comparison of 20-minute pad test versus 1-hour pad test in women with stress urinary incontinence. Urology. 2006;68(4):764–8.
Uebersax JS, Wyman JF, Shumaker SA, et al. Short forms to assess life quality and symptom distress for urinary incontinence in women: the incontinence impact questionnaire and the urogenital distress inventory. Continence program for women research group. Neurourol Urodyn. 1995;14(2):131–9.
Souza CC, Rodrigues AM, Ferreira CE, et al. Portuguese validation of the urinary incontinence - specific quality-of-life instrument: I-Qol. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:1183–9.
Djehdian LM, Araujo MP, 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. Obstet Gynecol. 2014;123(3):553–61.
Hagan KA, Erekson E, et al. A prospective study of the natural history of urinary incontinence in women. Am J Obstet Gynecol. 2018;218(5):502.e1–8.
Lamerton TJ, Torquati L, Brown WJ. Overweight and obesity as major, modifiable risk factors for urinary incontinence in young to mid-aged women: a systematic review and meta-analysis. Obes Rev. 2018;19(12):1735–45.
Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007;1101:266–96.
Yuksel MB, Kose O, Karakose A, et al. The comparison of short term results of transobturatour tape and single incision midurethral sling procedures. Int J Women’s Health Reprod Sci. 2013;1(3):80–7. https://doi.org/10.15296/ijwhr.2013.14.
Schellart RP, Oude Rengerink K, Van der Aa F, et al. A randomized comparison of single-incision midurethral sling in women with stress urinary incontinence: results of 12-mo follow-up. Eur Urol. 2014;66(6):1179–85. https://doi.org/10.1016/j.eururo.2014.07.027.
Nambiar A, Cody JD, Jeffery ST, et al. Single-incision operations for urinary incontinence in women. Cochrone Database Syst Rev. 2017;7:CD008709. https://doi.org/10.1002/14651858.CD008709.pub3.
Staat M, Trenz E, Lohmann P. New measurements to compare soft tissue anchoring systems in pelvic floor surgery. J Biomed Mater Res B Appl Biomater 2012.
Zhang P, Fan B, Zhang P, et al. Meta-analysis of female stress urinary incontinence treatments with adjustable single-incision mini-slings and transobturator tension-free vaginal tape surgeries. BMC Urol. 2015;15:64. https://doi.org/10.1186/s12894-015-0060-3.
Siddiqui NY, Wiseman JB, Cella D, et al. Mental health, sleep, and physical function in treatment-seeking women with urinary incontinence. J Urol. 2018;200(4):848–55.
Oliveira R, Botelho F, Silva P, et al. Single-incision sling system as primary treatment of female stress urinary incontinence: prospective 12 months data from single institution. BJU Int. 2011;108(10):1616–21. https://doi.org/10.1111/j.1464-410X.2011.10158.x.
Hillary CJ, Osman N, Chapple C. Considerations in the modern management of stress urinary incontinence resulting from intrinsic sphincter deficiency. World J Urol. 2015;33(9):1251–6. https://doi.org/10.1007/s00345-015-1599-z.
Spelzini F, Frigerio M, Regini C, Palmieri S, Manodoro S, Milani R. Learning curve for the single-incision suburethral sling procedure for female stress urinary incontinence. Int J Gynaecol Obstet. 2017;139(3):363–7.
Montera R, Plotti F, Ricciardi R, et al. Learning curves of a resident surgeon performing transobturator tape procedures for stress urinary incontinence. Int J Gynaecol Obstet. 2016;134(3):345–9. https://doi.org/10.1016/j.ijgo.2016.02.017.
Rehman H, Bezerra CA, Bruschini H, et al. Tradicional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2017;7:CD001754. https://doi.org/10.1002/14651858.CD001754.pub4.
Palos CC, Maturana AP, Ghersel FR, et al. Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety. Int Urogynecol J. 2018;29(1):29–35.
Taner CE, Okay G, Göklü Y, et al. Perioperative and postoperative complications after Ophira mini sling operations. Arch Gynecol Obstet. 2015;291(2):341–6. https://doi.org/10.1007/s00404-014-3402-6.
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Maturana, A.P., Palos, C.C., Ghersel, F.R. et al. Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence. Int Urogynecol J 31, 1925–1931 (2020). https://doi.org/10.1007/s00192-019-04145-y
- Transobturator sling
- Non-inferiority analysis
- Quality of life
- Urinary incontinence