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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hartford Hospital
• Collaborator: Astellas Pharma Inc
• Treatments: Solifenacin Succinate

Criteria

Inclusion Criteria:

• Female

• Age ≥ 18 years

• Have experienced symptoms of overactive bladder (e.g., urinary urgency, frequency, or urge incontinence) for at least 3 months. Specifically women must average 8 or more voids in 24 hours and have 3 or more episodes of urinary urgency or urge incontinence over the 72 hours when the diary is being completed.

• A practitioner trained in the pelvic organ prolapse quantification examination will evaluate each woman's pelvic organ support and vaginal dimensions. Women with a stage 1 or greater vaginal prolapse will be eligible for the study.

Exclusion Criteria:

• The presence of factors that would contraindicate use of antimuscarinic medications (e.g. urine retention, narrow angle glaucoma, uncontrolled constipation, dementia)

• An existing condition that would contraindicate use of a vaginal pessary (e.g., patient's vaginal length <6 cm)

• Patient is currently using a vaginal pessary.

• Patient is unable to tolerate an object in vagina

• Patient has a history of cervical, vaginal or endometrial cancer

• Patient is not able to speak English

• Patient is currently using an anticholinergic medication, or has used one in the past 30 days

• Patients with mixed urine incontinence that is predominantly stress urine incontinence (determined by their baseline PFDI)

• Patients with a known allergy to solifenacin.

• Patients with severe hepatic impairment.