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

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

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).

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.

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