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

  • Ana P. MaturanaEmail author
  • Claudia C. Palos
  • Frederico R. Ghersel
  • Cesar E. Fernandes
  • Emerson Oliveira
Original Article
  • 32 Downloads

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.

Keywords

Mini-sling Transobturator sling Non-inferiority analysis Complications Quality of life Urinary incontinence 

Notes

Compliance with ethical standards

Conflicts of interest

The authors declare that they have no conflict of interest.

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Copyright information

© The International Urogynecological Association 2019

Authors and Affiliations

  1. 1.Department of Urogynecology and Vaginal Surgery within the Discipline of GynecologyABC Medical SchoolSanto AndréBrazil
  2. 2.Rua Conselheiro LafayetteSão Caetano do SulBrazil

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