Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence (ROSE)
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ClinicalTrials.gov Identifier: NCT01115465 |
Recruitment Status : Unknown
Verified March 2020 by Uroplasty, Inc.
Recruitment status was: Active, not recruiting
First Posted : May 4, 2010
Last Update Posted : March 11, 2020
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Condition or disease | Intervention/treatment | Phase |
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Stress Urinary Incontinence | Device: Macroplastique | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 276 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence |
Actual Study Start Date : | January 2008 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | February 2022 |

Arm | Intervention/treatment |
---|---|
Macroplastique
Macroplastique will be used for the treatment in an open-label, five year, post-market study
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Device: Macroplastique
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
Other Names:
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- 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 ]To describe the incidence of additional or alternative treatments
- To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure. [ Time Frame: 5-years ]To describe the incidence of genitourinary and treatment related adverse events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115465

Responsible Party: | Uroplasty, Inc |
ClinicalTrials.gov Identifier: | NCT01115465 |
Other Study ID Numbers: |
MPQ092006 |
First Posted: | May 4, 2010 Key Record Dates |
Last Update Posted: | March 11, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Stress Urinary Incontinence silicone elastomer |
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |