Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: Macroplastique
- Registration Number
- NCT01115465
- Lead Sponsor
- Uroplasty, Inc
- Brief Summary
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).
- Detailed Description
The Rose Registry is a five-year post-market study of the safety and effectiveness of Macroplastique in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 276
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Macroplastique Macroplastique Macroplastique will be used for the treatment in an open-label, five year, post-market study
- Primary Outcome Measures
Name Time Method 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. 5-years To describe the incidence of additional or alternative treatments
- Secondary Outcome Measures
Name Time Method To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure. 5-years To describe the incidence of genitourinary and treatment related adverse events
Trial Locations
- Locations (19)
Kaiser Permanente Southern California-Irvine Medical Center
🇺🇸Irvine, California, United States
Urology Associates, PC
🇺🇸Englewood, Colorado, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Carolina Urology Partners
🇺🇸Gastonia, North Carolina, United States
Univeristy of California- Irvine
🇺🇸Orange, California, United States
Northwestern University Prentice Women's Hospital
🇺🇸Chicago, Illinois, United States
Southern Urogynecology
🇺🇸Columbia, South Carolina, United States
The Florida Bladder Institute
🇺🇸Naples, Florida, United States
Western Carolina Women's Specialty Center
🇺🇸Asheville, North Carolina, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Deaconess Clinic
🇺🇸Newburgh, Indiana, United States
Specialists in Urology
🇺🇸Naples, Florida, United States
Western New York Urology
🇺🇸Cheektowaga, New York, United States
The University of California- of San Diego
🇺🇸San Diego, California, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
The University of Michigan Health Center
🇺🇸Ann Arbor, Michigan, United States
Mercy Heatlh Partners at the Lakes
🇺🇸Muskegon, Michigan, United States
Athena Urology
🇺🇸Issaquah, Washington, United States