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Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence (ROSE)
This study is ongoing, but not recruiting participants.
Sponsor:
Uroplasty, Inc
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT01115465
First received: April 30, 2010
Last updated: May 4, 2017
Last verified: May 2017
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Purpose
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).
| Condition | Intervention |
|---|---|
| Stress Urinary Incontinence | Device: Macroplastique |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence |
Resource links provided by NLM:
Further study details as provided by Uroplasty, Inc:
Primary Outcome Measures:
- 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 additional or alternative treatments
Secondary Outcome Measures:
- To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure. [ Time Frame: 5-years ]To describe the incidence of genitourinary and treatment related adverse events
| Enrollment: | 276 |
| Actual Study Start Date: | January 2008 |
| Estimated Study Completion Date: | February 2022 |
| Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Macroplastique
Macroplastique will be used for the treatment in an open-label, five year, post-market study
|
Device: Macroplastique
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115465
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115465
Locations
| United States, Arizona | |
| Urological Associates of Southern Arizona | |
| Tucson, Arizona, United States, 85715 | |
| United States, California | |
| Kaiser Permanente Southern California-Irvine Medical Center | |
| Irvine, California, United States, 92618 | |
| Univeristy of California- Irvine | |
| Orange, California, United States, 92868 | |
| The University of California- of San Diego | |
| San Diego, California, United States, 92121 | |
| United States, Colorado | |
| Urology Associates, PC | |
| Englewood, Colorado, United States, 80113 | |
| United States, Florida | |
| Specialists in Urology | |
| Naples, Florida, United States, 34102 | |
| The Florida Bladder Institute | |
| Naples, Florida, United States, 34109 | |
| United States, Illinois | |
| Northwestern University Prentice Women's Hospital | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Deaconess Clinic | |
| Newburgh, Indiana, United States, 47630 | |
| United States, Michigan | |
| The University of Michigan Health Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| Mercy Heatlh Partners at the Lakes | |
| Muskegon, Michigan, United States, 49444 | |
| United States, New York | |
| Western New York Urology | |
| Cheektowaga, New York, United States, 14225 | |
| United States, North Carolina | |
| Western Carolina Women's Specialty Center | |
| Asheville, North Carolina, United States, 28806 | |
| Carolina Urology Partners | |
| Gastonia, North Carolina, United States, 28054 | |
| United States, Oklahoma | |
| University of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, South Carolina | |
| Southern Urogynecology | |
| Columbia, South Carolina, United States, 29169 | |
| United States, Virginia | |
| Urology of Virginia | |
| Virginia Beach, Virginia, United States, 23462 | |
| United States, Washington | |
| Athena Urology | |
| Issaquah, Washington, United States, 98027 | |
Sponsors and Collaborators
Uroplasty, Inc
More Information
| Responsible Party: | Uroplasty, Inc |
| ClinicalTrials.gov Identifier: | NCT01115465 History of Changes |
| Other Study ID Numbers: |
MPQ092006 |
| Study First Received: | April 30, 2010 |
| Last Updated: | May 4, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Uroplasty, Inc:
|
Stress Urinary Incontinence silicone elastomer |
Additional relevant MeSH terms:
|
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms |
Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders |
ClinicalTrials.gov processed this record on July 21, 2017