Podium Session

Poster, Podium & Video Sessions

PD54-09: First results – the Urge 1 study - randomized trial to compare solifenacin and bilateral mesh replacement of the uterosacral ligaments in the treatment of urgency urinary incontinence

Monday, May 15
10:50 AM - 11:00 AM
Location: BCEC: Room 159

Presentation Authors: Sebastian Ludwig*, Martin Stumm, Peter Mallmann, Wolfram Jäger, Cologne, Germany

Introduction: The etiology of urinary incontinence is unknown. Beside stress urinary incontinence (SUI), current treatment options are based on a neurological disorder or the detrusor. In the early 90s 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 introduced a standardized apical fixation: a bilateral mesh augmentation of the uterosacral ligaments: the cervicosacropexy (CESA) or vaginosacropexy (VASA). In order to evaluate the different hypotheses we compared the standard pharmacological treatment with the surgical approach of CESA or VASA in the treatment of urgency urinary incontinence (UUI) in women.


Comparison of therapeutic efficacy between solifenacin and CESA or VASA surgeries in women with involuntary urinary leakage.

Methods: Women with UUI symptoms and without previous treatment were eligible for this study. The study was approved by the local ethical committee (ClinicalTrails.gov Identifier: NCT01737411). UUI symptoms were assessed according to validated questionnaires. Urodynamics were performed before and after each treatment arm. Patients were randomized either in the solifenacin therapy arm (10mg) or in the surgical procedure arm. After 4 months the efficacy of each treatment arm was assessed. 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 augmentation and named cervicosacropexy (CESA) or vaginosacropexy (VASA) depending on the site of fixation. 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 prevertebral fascia of the S1/S2 sacral vertebra.

Results: 77 patients were evaluable for analysis. In total, after primary and secondary solifenacin treatment 3 out of 58 patients (5%) were cured. After primary and secondary CESA or VASA surgical treatment 26 out of 65 patients (40%) were cured of their UUI symptoms.

Conclusions: The CESA and VASA surgical procedures provide a therapy to cure 40% of patients from involuntary urinary leakage. Compared to the standard pharmacological treatment these surgical procedure depicts an option in the treatment of UUI.

Source Of Funding: None

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PD54-09: First results – the Urge 1 study - randomized trial to compare solifenacin and bilateral mesh replacement of the uterosacral ligaments in the treatment of urgency urinary incontinence



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