NCT01470001

The Effect of Solifenacin on Post Void Dribbling in Women

The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.

Detailed description

This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint. Secondary endpoints will include: 1. The % of patients with at least a 50% reduction in post void dribbling episodes. 2. Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life. We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators

Conditions

• Post-micturition Incontinence
• Incontinence

Interventions

Type	Name	Description
DRUG	solifenacin	patient will receive solifenacin 5mg daily or placebo daily

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2011-11-10
• Last updated: 2017-08-23
• Results posted: 2017-08-23

Locations

1 site across 1 country: United States