Therapy of urgency urinary incontinence in women - A randomized clinical trial to compare the effect of Solifenacin with the standardized bilateral replacement of the uterosacral ligaments

Ludwig S1, Jäger W1, Mallmann P1

Research Type


Abstract Category

Female Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 214
Female Lower Urinary Tract Symptoms / Voiding Dysfunction
Scientific Podium Short Oral Session 10
Wednesday 29th August 2018
14:35 - 14:42
Hall C
Urgency Urinary Incontinence Mixed Urinary Incontinence Surgery Overactive Bladder Pelvic Floor
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). Except SUI, and in regard to materials (length/width) and fixation/implantation sides no standardized surgical treatment for these levels were developed. 
We evaluated the effect of bilateral replacement of the uterosacral ligaments (USL) on urgency urinary incontinence and mixed urinary incontinence.
Study design, materials and methods
Randomized clinical trial comparing solifenacin and cervicosacropexy (CESA) or vaginosacropexy (VASA) in 96 women aged 35-80years with urgency urinary incontinence and mixed urinary incontinence and without previous treatment ( Identifier: NCT01737411). Efficacy of each treatment arm was assessed 4 months after. Cure was defined as voiding frequency <8 times/day and no involuntary leakage of urine. Polyvinylidene fluoride (PVDF) tapes of identical length were used for open abdominal USL and sutured either on cervix or vaginal stump and placed under the left and right peritoneal fold of the USL and attached to S1/S2 sacral vertebra.
55 patients were operated and 41 patients received the medical treatment. 23 patients (42%) had no symptoms of incontinence anymore after surgery compared to 4 patients (10%) under solifenacin treatment.
In 15 patients (27%) also the stress urinary symptoms disappeared after surgery compared to 1 patient (2%) under Solifenacin treatment.
Interpretation of results
Compared to the standard pharmacological treatment these surgical procedure depicts an option in the treatment of UUI.
Concluding message
The standardized replacement of the uterosacral ligaments led to continence in 42% of patients with urgency urinary incontinence and in 27% of patients with mixed urinary incontinence. These results were so different compared to the outcome of standard medical treatment that the study was stopped prematurely.
Figure 1
Figure 2
Funding None Clinical Trial Yes Registration Number Identifier: NCT01737411 RCT Yes Subjects None
23/06/2021 08:16:38