Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse

Pelvic organ prolapse (POP) affects approximately half of all women over age 501. The most
common type of POP is anterior vaginal wall prolapse. Symptoms associated with POP include:
voiding dysfunction, defecatory dysfunction and vaginal bulge symptoms. Treatments for
pelvic organ prolapse include among other options, vaginal pessary or surgery. Several
studies have documented improved vaginal bulge symptoms in women treated with a
pessary2,3,4; however, data are sparse regarding the effect of pessaries on lower urinary
tract symptoms, specifically with regard to over active bladder symptoms.

Overactive bladder, observed in approximately 40% of women 50 years of age or older, is very
common in women with pelvic organ prolapse. Two retrospective studies have shown improvement
in women with overactive bladder symptoms following treatment with a vaginal pessary. One
study (using a non-validated questionnaire) found that, at two month follow-up, patients
successfully fitted with a pessary experienced a reduction in slightly less than half of
their urge incontinence symptoms.5 A second study (using the Sheffield pelvic organ prolapse
symptom questionnaire), revealed that 4 months after insertion of a pessary, 38% of patients
experienced reduced urinary urgency, and 29% experienced reduced urge urinary incontinence6.
Despite these data, many women stop using a pessary secondary to complaints of increased
urine incontinence. More information is needed on pessary therapy impact on bladder
function.

Specific Aim(s):

This study will prospectively evaluate women with pelvic organ prolapse and overactive
bladder symptoms treated with either

1. a pessary and solifenacin, or

2. a pessary and placebo. We will assess the effects of these therapies on overactive
bladder symptoms over the course of the 14-week study.