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A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

NCT01762345 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2016-03-24

Study results available
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Summary

This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

pessary (disposable intra-vaginal device)

pessary device(disposable intra-vaginal device)manufactured by Procter \& Gamble

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
2012-12-31
Primary Completion
2013-07-31
Completion
2013-07-31

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 NCT01762345 on ClinicalTrials.gov