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

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

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).

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Macroplastique

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 Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Urological Associates of Southern Arizona
  • California
    • Irvine, California, United States, 92618
      • Kaiser Permanente Southern California-Irvine Medical Center
    • Orange, California, United States, 92868
      • Univeristy of California- Irvine
    • San Diego, California, United States, 92121
      • The University of California- of San Diego
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Urology Associates, PC
  • Florida
    • Naples, Florida, United States, 34102
      • Specialists in Urology
    • Naples, Florida, United States, 34109
      • The Florida Bladder Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Prentice Women's Hospital
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan Health Center
    • Muskegon, Michigan, United States, 49444
      • Mercy Heatlh Partners at the Lakes
  • New York
    • Cheektowaga, New York, United States, 14225
      • Western New York Urology
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Western Carolina Women's Specialty Center
    • Gastonia, North Carolina, United States, 28054
      • Carolina Urology Partners
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • South Carolina
    • Columbia, South Carolina, United States, 29169
      • Southern Urogynecology
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Issaquah, Washington, United States, 98027
      • Athena Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uroplasty, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence; silicone elastomer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: MPQ092006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No