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

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