Hypothesis / aims of study
The etiology of urinary incontinence, especially urgency urinary incontinence, is controversial. Beside stress urinary incontinence (SUI), current treatment options are based on a neurological disorder or the detrusor. Ulmsten and DeLancey hypothesized an anatomical defect of the anterior vaginal wall: laxity of the 3 levels (the paraurethral tissue, the apical end and vesicourethral junction). As a first study, we randomized patients with mixed and urgency urinary incontinence with solifenacin (as standard pharmacological treatment) against bilateral uterosacral ligaments replacement (apical fixation). Under solifenacin no disappearance of urgency incontinence symptoms was observed. In contrast, after surgical treatment a disappearance of urinary incontinence symptoms was observed in 42% of patients. In the current study, we evaluated the effect of an additional transobturator tape placement (in patients after bilateral apical fixation) in the remaining 58% of patients with urgency urinary incontinence and mixed urinary incontinence.
Study design, materials and methods
Women with UUI and MUI symptoms and previous CESA or VASA surgery were eligible for this study (ClinicalTrails.gov Identifier: NCT01737918). In all patients, the uterosacral ligaments were previously replaced by CESA or VASA surgery. Patients were randomized either in the solifenacin therapy arm or in the surgical procedure arm (transobturator tape placement, TOT). Efficacy of each treatment arm was assessed after 4 months. Cure/Continence was defined as voiding frequency <8 times/day and no involuntary leakage of urine, meaning no UUI or MUI symptoms at four months after start of treatment.
112 patients with UUI or MUI after apical fixation (cervicosacropexy, CESA, and vaginosacropexy, VASA) were randomized (solifenacin against transobturator tape (TOT) replacement). 52 patients received solifenacin, four patients did not continued the therapy. Out of these 52 patients, only one patient reported total improvement of urinary incontinence symptoms under solifenacin.
55 patients received a TOT, one patients did not show up to surgery. In 31 out of these 55 patients (56%) urinary continence was restored after transobturator tape placement.
Interpretation of results
The standard pharmacological treatment (solifenacin) for UUI symptoms restored continence in only one of these patients (under medication). In contrast, the additional TOT (after apical fixation) restored urinary continence in 56% of patients with mixed and urgency urinary incontinence symptoms.