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

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.

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Correspondence to Ana P. Maturana.

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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

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Keywords

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