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

Not Applicable

• Conditions: Stress Urinary Incontinence

• 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 276

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

Urological Associates of Southern Arizona; 🇺🇸 Tucson, Arizona, United States

Kaiser Permanente Southern California-Irvine Medical Center; 🇺🇸 Irvine, California, United States

Univeristy of California- Irvine; 🇺🇸 Orange, California, United States

The University of California- of San Diego; 🇺🇸 San Diego, California, United States

Urology Associates, PC; 🇺🇸 Englewood, Colorado, United States

Specialists in Urology; 🇺🇸 Naples, Florida, United States

The Florida Bladder Institute; 🇺🇸 Naples, Florida, United States

Northwestern University Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States

Deaconess Clinic; 🇺🇸 Newburgh, Indiana, United States

The University of Michigan Health Center; 🇺🇸 Ann Arbor, Michigan, United States

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