Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Uroplasty, Inc
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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
