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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01115465
Recruitment Status : Active, not recruiting
First Posted : May 4, 2010
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Uroplasty, Inc

Study Description
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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).

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Macroplastique Not Applicable

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.
Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Macroplastique
Macroplastique will be used for the treatment in an open-label, five year, post-market study
 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:
  • polydimethylsiloxane
  • PDMS


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Uroplasty, Inc
More Information
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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
Keywords provided by Uroplasty, Inc:
Stress Urinary Incontinence
silicone elastomer
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders