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

2014-07-23 21:09:45 | BioPortfolio

Summary

This study will evaluate the effect of pessary therapy, with and without Solifenacin (Vesicare), on symptoms of over active bladder and bladder function in women with overactive bladder symptoms and pelvic organ prolapse.

Study Hypotheses:

Null hypothesis, HO: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does not improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.

Alternate hypothesis, HA: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Pelvic Organ Prolapse

Intervention

Solifenacin, Placebo, Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex

Location

Hartford Hospital
Hartford
Connecticut
United States
06106

Status

Recruiting

Source

Hartford Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:45-0400

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