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Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

NCT03978741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-05-08

No results posted yet for this study

Summary

Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.

Conditions

Interventions

DEVICE

Yōni.Fit Test Device

The Yōni.Fit Test Device is a silicone pessary.

DEVICE

Yōni.Fit Comparator Device

The Yōni.Fit Comparator Device is a silicone pessary with a different configuration.

Sponsors & Collaborators

  • Watkins Conti Products. Inc.

    lead INDUSTRY

Principal Investigators

  • Allsion Watkins-Conti · Watkins Conti Products. Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2022-05-05
Completion
2022-08-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03978741 on ClinicalTrials.gov