CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
With Yoni.Fit +1 moredevice
Likely dose
Not stated in record
Key inclusion· 2
  • ✓QUID questionnaire SUI score of 5 or greater
  • ✓SUI score must be greater than UUI score
Key exclusion· 9
  • ✕SUI score less than 5
  • ✕SUI score less than or equal to UUI score
  • ✕Predominantly urge urinary incontinence (UUI)
  • ✕Prolapse greater than mild

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03010800
NCT03010800N/ACompleted
CompareCT.gov

Randomized, Crossover Feasibility Study of a Device to Prevent Female Urinary Stress Incontinence

Watkins Conti Products. Inc.·interventional·Posted Jan 5, 2017·Updated Jan 18, 2018

In Brief

A clinical study evaluating With Yoni.Fit and Without Yoni.Fit for Stress Incontinence, Female. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Incontinence, Female
CountriesUnited States
CollaboratorsUniversity of Oklahoma

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 5, 2017
Enrollment StartJan 4, 2017
Primary CompletionFeb 28, 2017
Study CompletionMay 3, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.5 years ago

Interventions

With Yoni.Fitdevice

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

Without Yoni.Fitdevice

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