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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Uroplasty, Inc
Sponsor:
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT01115465
First received: April 30, 2010
Last updated: March 5, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Stress Urinary Incontinence
Device: Macroplastique
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Uroplasty, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure. [ Time Frame: 5-years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 275
Study Start Date: January 2008
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macroplastique 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115465

  Show 21 Study Locations
Sponsors and Collaborators
Uroplasty, Inc
  More Information

No publications provided

Responsible Party: Uroplasty, Inc
ClinicalTrials.gov Identifier: NCT01115465     History of Changes
Other Study ID Numbers: MPQ092006
Study First Received: April 30, 2010
Last Updated: March 5, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Uroplasty, Inc:
Stress Urinary Incontinence
silicone elastomer

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on July 07, 2015