MedTrace Logo

Disposable Stress Urinary Incontinence Pessary Device Study

NCT03323723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2019-05-16

Study results available
· View outcomes & findings →

Summary

This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs. The sample size will consist of approximately 50 participants. Participants will undergo an initial control period in which preweighed pads will be worn for 7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive days where participants will wear both device and preweighed pads simultaneously. for 12 hours.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

SUI Device

Pessary SUI device

Sponsors & Collaborators

  • Rinovum Women's Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Omar Felipe Duenas Garcia, MD · West Virginia University Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2018-05-01
Completion
2018-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03323723 on ClinicalTrials.gov