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A Feasibility Device Study to Prevent Female Urinary Stress Incontinence

NCT03010800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-01-18

Study results available
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Summary

This study will test the acute efficacy of an investigational device (Yoni.Fit) in a clinical trial of women with incontinence in a standardized set of challenges performed with and without the device in place.

Conditions

  • Stress Incontinence, Female

Interventions

DEVICE

With Yoni.Fit

Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.

DEVICE

Without Yoni.Fit

Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.

Sponsors & Collaborators

  • University of Oklahoma

    collaborator OTHER

  • Watkins Conti Products. Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2017-02-28
Completion
2017-05-03

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 NCT03010800 on ClinicalTrials.gov