RecruitingNot ApplicableNCT04772131

Desara ® One Single Incision Sling 522 Study

Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence

Sponsor

Caldera Medical, Inc.

Enrollment

300 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study follows women who receive the Desara One — a minimally invasive sling device used to treat stress urinary incontinence (leaking urine when you cough, sneeze, or exercise). It is a post-market safety study to track how well the device works over time. **You may be eligible if...** - You are a woman 18 or older - You have stress urinary incontinence confirmed by a physical test (coughing test with a full bladder) - Your stress incontinence is more troublesome than urgency incontinence (the "gotta go" type) - You are no longer planning to have children (confirmed by past surgery, or a negative pregnancy test with a decision to stop childbearing) - You are willing to return for all follow-up visits **You may NOT be eligible if...** - You are currently pregnant or planning to become pregnant - Your incontinence is primarily the "urgency" type rather than stress - You have previously had certain pelvic mesh procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDesara® One Single Incision Sling

Single incision sling

DEVICEDesara® Blue Transobturator Sling

Standard mid-urethral sling

Locations(15)

Valley Urogynecology Associates, Inc.

Phoenix, Arizona, United States

University of Arizona College of Medicine

Tucson, Arizona, United States

Urological Research Center Corp

Hialeah, Florida, United States

Women's Health Care Associates P.A. dba Rosemark Women Care Specialists

Idaho Falls, Idaho, United States

CMB Research, LLC

Newburgh, Indiana, United States

University of Louisville

Louisville, Kentucky, United States

Mt. Auburn Hospital Division of Urogynecology

Cambridge, Massachusetts, United States

Specialty Clinical Research of St. Louis, LLC

St Louis, Missouri, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

University of New Mexico

Albuquerque, New Mexico, United States

Novant Health Urogynecology

Charlotte, North Carolina, United States

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

Center for Total Women's Health

Lansdale, Pennsylvania, United States

Center for Pelvic Health

Franklin, Tennessee, United States

University of Washington Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04772131

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