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

No Placebo-Only Group

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).

Eligible Conditions

Stress Incontinence

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.