Disposable Stress Urinary Incontinence Pessary Device Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 50 women with Stress Urinary Incontinence (SUI). Efficacy will be assessed by mean pad weight gain per hour, reduction of stress urinary incontinence events per day, and a quality of life questionnaire. The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03323723
Study type	Interventional
Source	Rinovum Women's Health, Inc.
Contact
Status	Completed
Phase	N/A
Start date	October 16, 2017
Completion date	May 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04829357` - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed	`NCT05493735` - Lidocaine for Pessary Check Pain Reduction	Phase 3
Completed	`NCT04512053` - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence	Phase 2
Active, not recruiting	`NCT06224335` - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting	`NCT05304312` - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women	N/A
Not yet recruiting	`NCT05527665` - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting	`NCT04558762` - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn	`NCT02524366` - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement	N/A
Completed	`NCT01924728` - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence	N/A
Completed	`NCT01676662` - Solace European Confirmatory Trial	N/A
Unknown status	`NCT01455779` - Lyrette: Renewing Continence Objective and Subjective Efficacy Study	N/A
Terminated	`NCT01029106` - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)	N/A
Withdrawn	`NCT00573703` - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence	Phase 4
Completed	`NCT01123096` - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?	N/A
Completed	`NCT01770691` - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence	N/A
Completed	`NCT00234754` - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women	N/A
Completed	`NCT00441454` - Retropubic vs. Transobturator Tension-free Vaginal Tape	N/A
Completed	`NCT03985345` - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.	N/A
Active, not recruiting	`NCT03671694` - Laser Vaginal Treatment for SUI	N/A
Completed	`NCT04097288` - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects	Phase 1