Clinical Trials Directory

Trials / Completed

CompletedNCT02131311

A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)

A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
145 (actual)
Sponsor
Procter and Gamble · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.

Conditions

Interventions

TypeNameDescription
DEVICEdisposable, single-use pessary

Timeline

Start date
2014-04-01
Primary completion
2014-09-01
Completion
2014-09-01
First posted
2014-05-06
Last updated
2016-03-24
Results posted
2016-03-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02131311. Inclusion in this directory is not an endorsement.

A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (S (NCT02131311) · Clinical Trials Directory