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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Macroplastique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Macroplastique<br>Macroplastique will be used for the treatment in an open-label, five year, post-market study | Device: Macroplastique<br>* Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).<br>* Other names: PDMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | To describe the incidence of additional or alternative treatments | 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure. | To describe the incidence of genitourinary and treatment related adverse events | 5-years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Urinary Incontinence, silicone elastomer