Desara ® One Single Incision Sling 522 Study
Start Date
11/1/2021
Completion Date
11/1/2026
Summary
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Detailed Description
This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 2 and 6 weeks, 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Desara® One Single Incision Sling
Desara® Blue Transobturator Sling
Conditions
Locations
Valley Urogynecology Associates, Inc.
Phoenix, Arizona 85016
United States
University of Arizona College of Medicine
Tucson, Arizona 85724
United States
Urological Research Center Corp
Hialeah, Florida 33016
United States
Women's Health Care Associates P.A. dba Rosemark Women Care Specialists
Idaho Falls, Idaho 83404
United States
CMB Research, LLC
Newburgh, Indiana 47630
United States
University of Louisville
Louisville, Kentucky 40202
United States
Mt. Auburn Hospital Division of Urogynecology
Cambridge, Massachusetts 02138
United States
Specialty Clinical Research of St. Louis, LLC
St Louis, Missouri 631471
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada 89169
United States
University of New Mexico
Albuquerque, New Mexico 87131
United States
Novant Health Urogynecology
Charlotte, North Carolina 28210
United States
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio 45219
United States
Center for Total Women's Health
Lansdale, Pennsylvania 19446
United States
Center for Pelvic Health
Franklin, Tennessee 37067
United States
University of Washington Medical Center
Seattle, Washington 98195
United States