Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence.
Int Urogynecol J
; 31(9): 1925-1931, 2020 09.
Article
em En
| MEDLINE
| ID: mdl-31784809
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Incontinência Urinária
/
Incontinência Urinária por Estresse
/
Slings Suburetrais
Tipo de estudo:
Clinical_trials
/
Guideline
Aspecto:
Patient_preference
Limite:
Female
/
Humans
Idioma:
En
Revista:
Int Urogynecol J
Assunto da revista:
GINECOLOGIA
/
UROLOGIA
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Reino Unido