Randomized trial to compare solifenacin and transobturator tape placement after apical fixation in the treatment of urgency urinary incontinence

Ludwig S1, Thangarajah F1, Podlinsky K1, Mallmann P1, Jäger W1

Research Type


Abstract Category

Overactive Bladder

Abstract 316
E-Poster 2
Scientific Open Discussion ePoster Session 18
Thursday 5th September 2019
13:25 - 13:30 (ePoster Station 3)
Exhibition Hall
Pharmacology Surgery Urgency Urinary Incontinence Mixed Urinary Incontinence Clinical Trial
1.University of Cologne

Sebastian Ludwig




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.
Concluding message
The bilateral replacement of the uterosacral ligaments by CESA and VASA surgical procedures in addition with the replacement of the pubourethral ligaments by a transobturator tape provided one therapy to restore continence in over three quarters of patients with UUI and MUI. Surgery for UUI symptoms outperformed medication and further studies should focus on the surgical correction of the vesicourethral junction.
Funding no Clinical Trial Yes Registration Number ClinicalTrails.gov Identifier: NCT01737918 RCT Yes Subjects Human Ethics Committee University of Cologne, Medical Faculty Helsinki Yes Informed Consent Yes