The Effect of Solifenacin on Post Void Dribbling in Women

Incontinence Clinical Trial

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

Status Completed

Clinical Trial 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 (PVD).

Clinical Trial Description

This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in PVD episodes (events) as the primary endpoint.

Secondary endpoints will include:

1. The % of patients with at least a 50% reduction in PVD episodes.

2. Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory (PFDI), 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 (PRC) will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators ;

Study Design

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

Related Conditions & MeSH terms

• Incontinence
• Post Micturition Dribble
• Postvoid Dribbling

• NCT number: NCT01470001
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Completion date: September 2015