Continence Pessary Versus Disposable Intravaginal Device Trial

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 1, 2017

Primary Completion Date

June 30, 2019

Study Completion Date

June 1, 2021

Conditions
Female Stress Incontinence
Interventions
DEVICE

Continence Pessary

Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.

DEVICE

Poise Impressa (Disposable Intravaginal Device)

In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.

Trial Locations (2)

27514

University of North Carolina, Chapel Hill

43210

Ohio State University, Columbus

All Listed Sponsors
collaborator

University of North Carolina, Chapel Hill

OTHER

lead

Ohio State University

OTHER

NCT03174431 - Continence Pessary Versus Disposable Intravaginal Device Trial | Biotech Hunter | Biotech Hunter