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

NCT02160314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2016-02-15

Study results available
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Summary

This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

pessary

disposable, single-use pessary

DEVICE

Absorbent pad

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Randall Severance, MD · Radiant Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-01-31
Completion
2015-01-31

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 NCT02160314 on ClinicalTrials.gov