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.
International urogynecology journal. 2019 Nov 29 [Epub ahead of print]
Ana P Maturana, Claudia C Palos, Frederico R Ghersel, Cesar E Fernandes, Emerson Oliveira
Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil. ., Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.