N/A N=8 Randomized Prevention

A Feasibility Device Study to Prevent Female Urinary Stress Incontinence

Stress Incontinence, Female

Bottom Line

View on ClinicalTrials.gov: NCT03010800 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: Pad Weight Difference — 0.0; 0.0; 0.0; 0.3 grams — p=0.0469

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: With Yoni.Fit (Device); Without Yoni.Fit (Device)
Age: Adult, Older Adult · 25+ yrs
Sex: Female
Sponsor: Watkins Conti Products. Inc.
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Pad Weight Difference	0.0; 0.0; 0.0; 0.3; 0.1; 2.4	0.0469 sig

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03010800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.