Stress Urinary Incontinence
Conditions
Keywords
Stress Urinary Incontinence, silicone elastomer
Brief summary
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).
Detailed 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.
Interventions
DEVICEMacroplastique
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
Sponsors
Uroplasty, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 5-years | To describe the incidence of additional or alternative treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure. | 5-years | To describe the incidence of genitourinary and treatment related adverse events |
Countries
United States
Outcome results
None listed