Randomized trial to compare solifenacin and transobturator tape placement after bilateral uterosacral ligament replacement in the treatment of urgency urinary incontinence - first results

Ludwig S1, Jäger W1, Mallmann P1

Research Type


Abstract Category

Female Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 340
Open Discussion ePosters
Scientific Open Discussion Session 21
Thursday 30th August 2018
13:15 - 13:20 (ePoster Station 3)
Exhibition Hall
Stress Urinary Incontinence Mixed Urinary Incontinence Urgency Urinary Incontinence Surgery Overactive Bladder
1. University of Cologne, Germany

Sebastian Ludwig




Hypothesis / aims of study
The etiology of urinary incontinence is unknown. 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). 
We evaluated the effect of a transobturator tape placement (in patients with bilateral replacement of the uterosacral ligaments) on 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.
45 patients with UUI or MUI after CESA or VASA surgery were randomized and were evaluable for analysis. In the solifenacin treatment arm one of the 22 patients treated with solifenacin were cured. In 15 out of 23 patients (65%) continence was restored after transobturator tape placement.
The replacement of the pubourethral ligaments with a transobturator tape (TOT) restored continence in 65% of patients with UUI or MUI.
Interpretation of results
The standard pharmacological treatment (solifenacin) for UUI symptoms could not restore continence in these patients.
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 75% of patients with UUI and MUI. Surgery for UUI symptoms outperformed medication.
Figure 1
Funding None Clinical Trial Yes Registration Number ClinicalTrails.gov Identifier: NCT01737918 RCT Yes Subjects None
13/07/2024 02:17:23