Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
ROSE
Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
1 other identifier
interventional
276
1 country
19
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMarch 11, 2020
March 1, 2020
13.9 years
April 30, 2010
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
To describe the incidence of additional or alternative treatments
5-years
Secondary Outcomes (1)
To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.
5-years
Study Arms (1)
Macroplastique
OTHERMacroplastique will be used for the treatment in an open-label, five year, post-market study
Interventions
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uroplasty, Inclead
Study Sites (19)
Urological Associates of Southern Arizona
Tucson, Arizona, 85715, United States
Kaiser Permanente Southern California-Irvine Medical Center
Irvine, California, 92618, United States
Univeristy of California- Irvine
Orange, California, 92868, United States
The University of California- of San Diego
San Diego, California, 92121, United States
Urology Associates, PC
Englewood, Colorado, 80113, United States
Specialists in Urology
Naples, Florida, 34102, United States
The Florida Bladder Institute
Naples, Florida, 34109, United States
Northwestern University Prentice Women's Hospital
Chicago, Illinois, 60611, United States
Deaconess Clinic
Newburgh, Indiana, 47630, United States
The University of Michigan Health Center
Ann Arbor, Michigan, 48109, United States
Mercy Heatlh Partners at the Lakes
Muskegon, Michigan, 49444, United States
Western New York Urology
Cheektowaga, New York, 14225, United States
Western Carolina Women's Specialty Center
Asheville, North Carolina, 28806, United States
Carolina Urology Partners
Gastonia, North Carolina, 28054, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Southern Urogynecology
Columbia, South Carolina, 29169, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
Athena Urology
Issaquah, Washington, 98027, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2010
First Posted
May 4, 2010
Study Start
January 1, 2008
Primary Completion
December 1, 2021
Study Completion
February 1, 2022
Last Updated
March 11, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share