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, Mallmann P1, Jäger W1

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 159
E-Poster 1
Scientific Open Discussion ePoster Session 7
Wednesday 4th September 2019
13:15 - 13:20 (ePoster Station 9)
Exhibition Hall
Pharmacology Urgency Urinary Incontinence Prospective Study Overactive Bladder Surgery
1.University of Cologne
Presenter
S

Sebastian Ludwig

Links

Poster

Abstract

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 (ClinicalTrails.gov 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. Patients were randomized either in the pharmacological therapy arm (10mg solifenacin for 4 months) or in the surgical procedure arm (CESA or VASA surgery). After 4 months the efficacy of each treatment arm was assessed by incontinence questionnaires. Cure was defined by the following: voiding frequency <8 times/day, no involuntary leakage of urine and no stress urinary incontinence. The non-responders were crossed-over. 
For open abdominal augmentation of the uterosacral ligaments polyvinylidene fluoride (PVDF) tapes of identical length were used and named cervico-sacropexy (CESA) or vagino-sacropexy (VASA) depending on the site of fixation (sacrum/cervix or sacrum/vagina). These tapes were sutured either on the cervix or vaginal stump and placed under the left and right peritoneal fold of the USL from the rectum and attached to the pre-sacral fascia in front of the S1/S2 sacral vertebra.
Results
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 Flowchart
Disclosures
<span class="text-strong">Funding</span> no dis <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Registration Number</span> ClinicalTrails.gov Identifier: NCT01737411 <span class="text-strong">RCT</span> Yes <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> University of Cologne, Medical Faculty <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes