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

Uroplasty

Status

Unknown

Conditions

Stress Urinary Incontinence

Treatments

Device: Macroplastique

Study type

Interventional

Funder types

Industry

Identifiers

NCT01115465

MPQ092006

Details and patient eligibility

About

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).

Full description

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.

Enrollment

276 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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