1| Volume 211, P199, April 2017

Urge 1 Study – A randomized cross-over clinical trial to compare medical treatment of urgency urinary incontinence with surgical treatment

      Introduction: It is believed that urgency urinary incontinence (UUI) is caused by detrusor hyperactivity. Solifenacin is considered as a first-line standard medical treatment. However, after repair of vaginal prolapse by a bilateral replacement of the uterosacral ligaments and a repair of the anterior compartment 90% of patients with UUI were cured. Since UUI symptoms were identical in patients with less prolapse we considered that also minor defects of the vaginal apical holding apparatus could lead to UUI. Unilateral apical vaginal fixation did not lead to cure, therefore a bilateral replacement of the USL by cervico-sacropexy (CESA) or vagino-sacropexy (VASA) was developed.
      Methods: Women with UUI without genital prolapse were eligible for this study ( Identifier: NCT01737411). UUI symptoms were assessed as usual. Patients were randomized either to 10 mg solifenacin for 4 months or to surgery (CESA or VASA). The surgical procedures of CESA and VASA had been published and described in detail (
      Cure was defined by the following: voiding frequency <8 times/day, no involuntary leakage of urine and no stress urinary incontinence. After 4 months the still incontinent women received the treatment of the other arm.
      Results: 77 patients were evaluable for analysis. In total, after primary solifenacin treatment 3 out of 58 patients (5%) were cured. After primary CESA or VASA surgical treatment 16 out of 40 patients (40%) were cured of their UUI symptoms. After cross-over one was cured by solifenacin of the 21 who failed surgery, however, 10 patients of 25 (40%) who failed solifenacin became continent. Therefore, the overall cure rate was 5% for solifenacin and 40% for the surgery (p = <0.001).
      Conclusions: The CESA and VASA surgical procedures provide a causal therapy in the treatment of involuntary urinary leakage.