A Feasibility Device Study to Prevent Female Urinary Stress Incontinence

Completed · Not applicable

Conditions studied: Stress Incontinence, Female

In brief

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.

Key facts

Study ID

NCT03010800

Run by

Watkins Conti Products. Inc.

People needed

8

Starts

2017-01-04

Expected to finish

2017-05-03

Last updated by the study team

2018-01-18

Who can join

Age: 25 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Urinary Incontinence Diagnosis (QUID). This questionnaire has 3 questions each referring to the seriousness of Stress Urinary Incontinence (SUI) and of Urge Urinary Incontinence (UUI). Subjects will be accepted if their SUI score is 5 or greater and is greater than the UUI score.

You may not qualify if…

• Refusal to sign the informed consent document
• SUI score is less than 5 or is less than the UUI score.
• Predominantly UUI
• Prolapse greater than mild
• Hysterectomy or other pelvic floor surgery other than a Caesarian section
• Diabetes,
• Pregnant,
• BMI>35 or unable to perform ten "jumping jack" exercises.

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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