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

This study is currently recruiting participants.
Verified March 2014 by Uroplasty, Inc
Sponsor:
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT01115465
First received: April 30, 2010
Last updated: March 5, 2014
Last verified: March 2014
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115465

Contacts
Contact: Megan O'Toole 952-426-6153 megan.otoole@uroplasty.com
Contact: Joann Allaf 952-426-6154 joann.allaf@uroplasty.com

Locations
United States, Arizona
Urological Associates of Southern Arizona Recruiting
Tucson, Arizona, United States, 85715
Contact: Ruben Andrade         
Principal Investigator: Susan Kalota, MD         
United States, California
Kaiser Permanente Southern California-Irvine Medical Center Recruiting
Irvine, California, United States, 92618
Contact: Marie Peets         
Principal Investigator: Emily Whitcomb         
Sub-Investigator: Jennifer Lee         
Sub-Investigator: Noelani Guaderrama         
The University of California- of San Diego Recruiting
La Jolla, California, United States, 92083
Contact: Gina Balzon         
Contact: JoAnn Columbo         
Principal Investigator: Emily S Lukacz         
Univeristy of California- Irvine Recruiting
Orange, California, United States, 92868
Contact: Douglas Skarecky         
Principal Investigator: Gamal Ghoniem, MD         
United States, Florida
Specialists in Urology Recruiting
Naples, Florida, United States, 34102
Contact: Brittney Decker         
Principal Investigator: Earl Gurevitch, MD         
United States, Illinois
Northwestern University Prentice Women's Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Kimberly Kenton         
United States, Michigan
The University of Michigan Health Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Steven Perry         
Principal Investigator: John Stoffel         
Mercy Heatlh Partners at the Lakes Recruiting
Muskegon, Michigan, United States, 49444
Contact: Jeanne Nielsen         
Sub-Investigator: Wooldridge Leslie, NP         
Principal Investigator: Willard DeBraber, DO         
United States, Minnesota
Metro Urology Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Cindy Holtz    651-999-6800      
Principal Investigator: Steve Siegel, MD         
United States, North Carolina
Western Carolina Women's Specialty Center Recruiting
Asheville, North Carolina, United States, 28806
Contact: Susan Shinn         
Principal Investigator: James Theofrastous         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kelly Burton         
Principal Investigator: Abbas Shobeiri, MD         
United States, Virginia
The Female Pelvic Medicine Institute of Virginia, P.C. Recruiting
Chesterfield, Virginia, United States, 23235
Contact: Suzanne Leary         
Principal Investigator: Nathan Guerette         
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Laurie Jackson         
Principal Investigator: Kurt McCammon         
United States, Washington
Athena Urology Recruiting
Issaquah, Washington, United States, 98027
Contact: Kathy Raich, RN         
Principal Investigator: Lora Plaskon, MD         
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, 2014
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
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014