Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence (ROSE)
This study is currently recruiting participants.
Verified January 2013 by Uroplasty, Inc
Sponsor:
Uroplasty, Inc
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT01115465
First received: April 30, 2010
Last updated: March 11, 2013
Last verified: January 2013
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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 | Phase |
|---|---|---|
|
Stress Urinary Incontinence |
Device: Macroplastique |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 275 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Macroplastique |
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115465
Contacts
| Contact: Megan O'Toole | 952-426-6153 | megan.otoole@uroplasty.com |
| Contact: Katie Welliver | 952-426-6182 | katie.welliver@uroplasty.com |
Locations
| United States, California | |
| Univeristy of California- Irvine | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Douglas Skarecky 714-456-3330 | |
| Principal Investigator: Gamal Ghoniem, MD | |
| United States, Florida | |
| Specialists in Urology | Recruiting |
| Naples, Florida, United States, 34102 | |
| Contact: Brittney Decker 239-434-6300 | |
| Principal Investigator: Earl Gurevitch, MD | |
| United States, Michigan | |
| Mercy Heatlh Partners at the Lakes | Recruiting |
| Muskegon, Michigan, United States, 49444 | |
| Contact: Jeanne Nielsen 231-773-3228 | |
| Sub-Investigator: Wooldridge Leslie, NP | |
| Principal Investigator: Willard DeBraber, DO | |
| United States, Minnesota | |
| Metro Urology | Recruiting |
| Woodbury, Minnesota, United States, 55125 | |
| Contact: Cindy Holtz 651-999-6800 | |
| Principal Investigator: Steve Siegel, MD | |
| United States, Oklahoma | |
| University of Oklahoma | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Michelle Norris 405-271-9493 | |
| Principal Investigator: Abbas Shobeiri, MD | |
| United States, Washington | |
| Athena Urology | Recruiting |
| Issaquah, Washington, United States, 98027 | |
| Contact: Kathy Raich, RN 425-392-8611 | |
| Principal Investigator: Lora Plaskon, MD | |
Sponsors and Collaborators
Uroplasty, Inc
More Information
No publications provided
| Responsible Party: | Uroplasty, Inc |
| ClinicalTrials.gov Identifier: | NCT01115465 History of Changes |
| Other Study ID Numbers: | MPQ092006 |
| Study First Received: | April 30, 2010 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Uroplasty, Inc:
|
Stress Urinary Incontinence silicone elastomer |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013