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 May 2014 by Uroplasty, Inc
Sponsor:
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT01115465
First received: April 30, 2010
Last updated: May 15, 2014
Last verified: May 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
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

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, MD         
Sub-Investigator: Jennifer Lee, MD         
Sub-Investigator: Noelani Guaderrama, MD         
The University of California- of San Diego Not yet recruiting
La Jolla, California, United States, 92083
Contact: JoAnn Columbo         
Principal Investigator: Emily S Lukacz, MD         
Univeristy of California- Irvine Recruiting
Orange, California, United States, 92868
Contact: Douglas Skarecky         
Principal Investigator: Gamal Ghoniem, MD         
United States, Colorado
Urology Associates, PC Recruiting
Englewood, Colorado, United States, 80113
Contact: Keith Gryder-Childers         
Principal Investigator: Barrett Cowan, MD         
United States, Florida
Specialists in Urology Terminated
Naples, Florida, United States, 34102
United States, Illinois
Northwestern University Prentice Women's Hospital Not yet recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Christina Gaupp, MD         
United States, Michigan
The University of Michigan Health Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Steven Perry         
Principal Investigator: John Stoffel, MD         
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 Not yet recruiting
Asheville, North Carolina, United States, 28806
Contact: Susan Shinn         
Principal Investigator: James Theofrastous, MD         
Carolina Urology Partners Recruiting
Gastonia, North Carolina, United States, 28054
Contact: Nicol Brandon         
Principal Investigator: Todd Cohen, MD         
Sub-Investigator: David Konstandt, MD         
Sub-Investigator: Stewart Polsky, MD         
Sub-Investigator: Michael Brame, MD         
Sub-Investigator: T. Brian Willard, MD         
United States, Oklahoma
University of Oklahoma Completed
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Southern Urogynecology Recruiting
Columbia, South Carolina, United States, 59169
Contact: Karen Johnson         
Principal Investigator: Andrea Pezzella, MD         
United States, Tennessee
Center for Pelvic Health Not yet recruiting
Franklin, Tennessee, United States, 37067
Contact: Debbie Loope         
Principal Investigator: Barry Jarnagin, 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, MD         
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Laurie Jackson         
Principal Investigator: Kurt McCammon, MD         
United States, Washington
Athena Urology Completed
Issaquah, Washington, United States, 98027
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: May 15, 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 July 24, 2014