Comparison of Solifenacin and Bilateral Apical Fixation in the Treatment of Mixed and Urgency Urinary Incontinence in Women: URGE 1 Study, A Randomized Clinical Trial.

BACKGROUND

The aetiology of urgency urinary incontinence is a matter of debate. Current treatment options are based on the hypothesis of a neurological disorder of bladder innervation. However, it has also been hypothesised that one main cause is the reduced function of the bladder-holding apparatus, that is, insufficient suspension of the vesico-urethral junction. This study compared the effects of surgical apical vaginal elevation with those of solifenacin on urgency urinary incontinence in women.

PATIENTS AND METHODS

Women with mixed and urgency urinary incontinence were randomised to either an established pharmacological arm (10 mg/day solifenacin) or the surgical arm (bilateral uterosacral ligament replacement, cervicosacropexy, CESA; or vaginosacropexy, VASA. Clinical and objective outcomes were assessed at 4 months after each type of intervention.

RESULTS

The study was terminated early; 55 patients were operated on and 41 patients received pharmacological treatment. After surgical treatment, 23 patients (42%, 95% confidence intervaI=29-55%) became continent compared to four patients (10%, 95% confidence intervaI=1-19%) during solifenacin treatment.

CONCLUSION

Compared to pharmacological treatment, the surgical repair of the apical vaginal end restored urinary continence in significantly more patients.