Summary

for females ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Stress Urinary Incontinence silicone elastomer Urinary Incontinence Enuresis Urinary Incontinence, Stress Macroplastique

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Univeristy of California- Irvine
    Orange California 92868 United States
  • Kaiser Permanente Southern California-Irvine Medical Center
    Irvine California 92618 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Uroplasty, Inc
ID
NCT01115465
Study Type
Interventional
Last Updated