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Published in: International Urogynecology Journal 9/2020

01-09-2020 | Stress Incontinence | Original Article

Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence

Authors: Ana P. Maturana, Claudia C. Palos, Frederico R. Ghersel, Cesar E. Fernandes, Emerson Oliveira

Published in: International Urogynecology Journal | Issue 9/2020

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Abstract

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.

Methods

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).

Results

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).

Conclusions

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.
Literature
1.
go back to reference 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.CrossRef 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.CrossRef
6.
go back to reference 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.PubMed 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.PubMed
7.
go back to reference 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.CrossRef 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.CrossRef
8.
go back to reference 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.CrossRef 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.CrossRef
9.
go back to reference 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.CrossRef 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.CrossRef
10.
go back to reference Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol. 2001;11(6):1306–13.PubMed Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol. 2001;11(6):1306–13.PubMed
11.
go back to reference 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.CrossRef 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.CrossRef
15.
go back to reference Molden SM, Lucente VR. New minimally invasive slings: TVT Secur. Curr Urol Rep. 2008;9:356–61.CrossRef Molden SM, Lucente VR. New minimally invasive slings: TVT Secur. Curr Urol Rep. 2008;9:356–61.CrossRef
16.
go back to reference 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.CrossRef 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.CrossRef
17.
go back to reference 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.CrossRef 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.CrossRef
18.
go back to reference 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.CrossRef 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.CrossRef
19.
go back to reference 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.CrossRef 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.CrossRef
20.
go back to reference 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.CrossRef 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.CrossRef
21.
go back to reference 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.CrossRef 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.CrossRef
22.
go back to reference 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.CrossRef 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.CrossRef
23.
go back to reference Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007;1101:266–96.CrossRef Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007;1101:266–96.CrossRef
27.
go back to reference 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. 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.
29.
go back to reference 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.CrossRef 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.CrossRef
32.
go back to reference 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.CrossRef 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.CrossRef
35.
go back to reference 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.CrossRef 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.CrossRef
Metadata
Title
Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence
Authors
Ana P. Maturana
Claudia C. Palos
Frederico R. Ghersel
Cesar E. Fernandes
Emerson Oliveira
Publication date
01-09-2020
Publisher
Springer International Publishing
Published in
International Urogynecology Journal / Issue 9/2020
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-019-04145-y

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