Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

Status unconfirmed · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

The ROSE Registry will determine the long-term safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).

Key facts

Study ID

NCT01115465

Run by

Uroplasty, Inc

People needed

276

Starts

2008-01-01

Expected to finish

2022-02-01

Last updated by the study team

2020-03-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject has signed written informed consent
• Subject is a female at least 18 years of age
• Subject has been diagnosed with SUI primarily due to intrinsic sphincter deficiency (ISD)
• Subject understands all study requirements including five year follow-up schedule
• Subject is psychologically stable and suitable for intervention as determined by the Investigator

You may not qualify if…

• Subject has an acute urogenital tract inflammation or infection
• Subject is pregnant or intends to become pregnant within one year
• Subject has had a sling placement within 12 weeks
• Subject has had a bulking agent treatment within 12 weeks
• Subject has a bladder neck or urethral stricture, gross utero-vaginal prolapse, untreated detrusor instability or hyperreflexia, neuropathic bladder, or overflow incontinence

Where it is running

• Urological Associates of Southern Arizona — Tucson, Arizona, United States
• Kaiser Permanente Southern California-Irvine Medical Center — Irvine, California, United States
• Univeristy of California- Irvine — Orange, California, United States
• The University of California- of San Diego — San Diego, California, United States
• Urology Associates, PC — Englewood, Colorado, United States
• Specialists in Urology — Naples, Florida, United States
• The Florida Bladder Institute — Naples, Florida, United States
• Northwestern University Prentice Women's Hospital — Chicago, Illinois, United States
• Deaconess Clinic — Newburgh, Indiana, United States
• The University of Michigan Health Center — Ann Arbor, Michigan, United States
• Mercy Heatlh Partners at the Lakes — Muskegon, Michigan, United States
• Western New York Urology — Cheektowaga, New York, United States
• Western Carolina Women's Specialty Center — Asheville, North Carolina, United States
• Carolina Urology Partners — Gastonia, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Southern Urogynecology — Columbia, South Carolina, United States
• Urology of Virginia — Virginia Beach, Virginia, United States
• Athena Urology — Issaquah, Washington, United States

Full record on ClinicalTrials.gov

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