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NCT01115465 Clinical Trial

Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

— ROSE  

Official title:
Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01115465
Other study ID # MPQ092006
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 2008
Est. completion date February 2022

Study information
Verified date March 2020
Source Uroplasty, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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 information / eligibility
Status Active, not recruiting
Enrollment 276
Est. completion date February 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Macroplastique
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).

Locations
Country Name City State
United States The University of Michigan Health Center Ann Arbor Michigan
United States Western Carolina Women's Specialty Center Asheville North Carolina
United States Western New York Urology Cheektowaga New York
United States Northwestern University Prentice Women's Hospital Chicago Illinois
United States Southern Urogynecology Columbia South Carolina
United States Urology Associates, PC Englewood Colorado
United States Carolina Urology Partners Gastonia North Carolina
United States Kaiser Permanente Southern California-Irvine Medical Center Irvine California
United States Athena Urology Issaquah Washington
United States Mercy Heatlh Partners at the Lakes Muskegon Michigan
United States Specialists in Urology Naples Florida
United States The Florida Bladder Institute Naples Florida
United States Deaconess Clinic Newburgh Indiana
United States University of Oklahoma Oklahoma City Oklahoma
United States Univeristy of California- Irvine Orange California
United States Oregon Health & Science University Portland Oregon
United States The University of California- of San Diego San Diego California
United States Urological Associates of Southern Arizona Tucson Arizona
United States Urology of Virginia Virginia Beach Virginia

Sponsors (1)
Lead Sponsor Collaborator
Uroplasty, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure. To describe the incidence of genitourinary and treatment related adverse events 5-years
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