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

NCT02131311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2016-03-24

Study results available
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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

  • Stress Urinary Incontinence (SUI)

Interventions

DEVICE

disposable, single-use pessary

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Randall Severance, MD · Radiant Research, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02131311 on ClinicalTrials.gov