Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
This trial is active, not recruiting.
|Condition||stress urinary incontinence|
|Start date||January 2008|
|End date||December 2021|
|Trial size||275 participants|
|Trial identifier||NCT01115465, MPQ092006|
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).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Tucson, AZ||Urological Associates of Southern Arizona||no longer recruiting|
|Irvine, CA||Kaiser Permanente Southern California-Irvine Medical Center||no longer recruiting|
|Orange, CA||Univeristy of California- Irvine||no longer recruiting|
|San Diego, CA||The University of California- of San Diego||no longer recruiting|
|Englewood, CO||Urology Associates, PC||no longer recruiting|
|Naples, FL||Specialists in Urology||no longer recruiting|
|Naples, FL||The Florida Bladder Institute||no longer recruiting|
|Chicago, IL||Northwestern University Prentice Women's Hospital||no longer recruiting|
|Newburgh, IN||Deaconess Clinic||no longer recruiting|
|Ann Arbor, MI||The University of Michigan Health Center||no longer recruiting|
|Muskegon, MI||Mercy Heatlh Partners at the Lakes||no longer recruiting|
|Cheektowaga, NY||Western New York Urology||no longer recruiting|
|Asheville, NC||Western Carolina Women's Specialty Center||no longer recruiting|
|Gastonia, NC||Carolina Urology Partners||no longer recruiting|
|Oklahoma City, OK||University of Oklahoma||no longer recruiting|
|Portland, OR||Oregon Health & Science University||no longer recruiting|
|Columbia, SC||Southern Urogynecology||no longer recruiting|
|Chesterfield, VA||The Female Pelvic Medicine Institute of Virginia, P.C.||no longer recruiting|
|Virginia Beach, VA||Urology of Virginia||no longer recruiting|
|Issaquah, WA||Athena Urology||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To describe the incidence of additional or alternative treatment for stress urinary incontinence due to ISD following up to two Macroplastique treatments over a 5 year period.
time frame: 5-years
To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.
time frame: 5-years
Female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence|
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