Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial.
Arch Gynecol Obstet
; 299(4): 1015-1022, 2019 04.
Article
em En
| MEDLINE
| ID: mdl-30805706
ABSTRACT
PURPOSE:
Midurethral slings are a well-established treatment option in women suffering stress urinary incontinence. Various different products and methods are used, therefore, the aim of our study was to compare two inside-out retropubic slings (TVT exact® vs. RetroArc®) inserted in two different ways regarding perioperative and mid-term outcomes.METHODS:
In this prospective randomized controlled non-inferiority multicentre trial, primary endpoint was postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire). Secondary endpoints were patients' satisfaction (Likert scale; ICIQ-UI-SF questionnaires). In addition, intra-and postoperative complications were evaluated. The TVT®-group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc®-group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200 ml) during the procedure.RESULTS:
Of the 303 women, 152 were randomized to the TVT® and 151 to the RetroArc® operation. At 3 months, n = 288 (95.0%) and at 12 months n = 229 (75.6%) were assessed. In postoperative objective cure the RetroArc®-procedure was not inferior to TVT® (p = 0.144). In subjective cure, however, the TVT exact® procedure achieved significant better results (TVT® 76.1%, RetroArc® 54.3%, p = 0.002). Perioperative complications were in majority voiding difficulties and lower after the TVT exact®-procedure.CONCLUSIONS:
Retropubic sling procedures are safe and successful to treat female stress urinary incontinence. However, different materials and techniques result in differences between outcomes also experienced surgeons should be aware of.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Incontinência Urinária por Estresse
/
Slings Suburetrais
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Adult
/
Aged
/
Female
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Humans
/
Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article