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Bulking Agent

Macroplastique for Stress Incontinence (ROSE Trial)

N/A
Waitlist Available
Research Sponsored by Uroplasty, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-years
Awards & highlights

ROSE Trial Summary

This study is evaluating whether a surgery to tighten the muscles around the urethra can help women with stress urinary incontinence.

Eligible Conditions
  • Stress Incontinence

ROSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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.
Secondary outcome measures
To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.

ROSE Trial Design

1Treatment groups
Experimental Treatment
Group I: MacroplastiqueExperimental Treatment1 Intervention
Macroplastique will be used for the treatment in an open-label, five year, post-market study

Find a Location

Who is running the clinical trial?

Uroplasty, IncLead Sponsor
5 Previous Clinical Trials
466 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
2008. "Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01115465.
All > Urinary Incontinence
~16 spots leftby May 2025
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