This trial is active, not recruiting.

Condition stress urinary incontinence
Treatment macroplastique
Phase phase 4
Sponsor Uroplasty, Inc
Start date January 2008
End date December 2021
Trial size 275 participants
Trial identifier NCT01115465, MPQ092006


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
macroplastique polydimethylsiloxane
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).

Primary Outcomes

To describe the incidence of additional or alternative treatment for stress urinary incontinence due to ISD following up to two Macroplastique treatments over a 5 year period.
time frame: 5-years

Secondary Outcomes

To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.
time frame: 5-years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Uroplasty, Inc.