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Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial.
Marschke, Juliane; Reisenauer, Christl; Mikkola, Tomi S; Schwab, Frank; Tunn, Ralf; Huebner, Markus.
Afiliação
  • Marschke J; Department of Urogynecology, German Pelvic Floor Centre, St. Hedwig Hospital, Große Hamburger Strasse 5-11, 10115, Berlin, Germany. j.marschke@alexianer.de.
  • Reisenauer C; Department of Women's Health, University Hospital of Tuebingen, Tüebingen, Germany.
  • Mikkola TS; Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland.
  • Schwab F; Department of Hygiene and Environmental Medicine, Charité, Universitätsmedizin Berlin, Berlin, Germany.
  • Tunn R; Department of Urogynecology, German Pelvic Floor Centre, St. Hedwig Hospital, Große Hamburger Strasse 5-11, 10115, Berlin, Germany.
  • Huebner M; Department of Women's Health, University Hospital of Tuebingen, Tüebingen, Germany.
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.
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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 / Humans / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article

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 / Humans / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article