NCT00801203

A Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence

A Phase II/III Controlled Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Pneumoflex Systems, LLC · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI) in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic testing by evaluation of sensitivity and specificity.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DRUG	IRCT	Up to two administrations of the IRCT during a single cough testing session

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-12-03
• Last updated: 2012-05-09

Locations

10 sites across 1 country: United States