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

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