Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence - Full Text View

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:

MedlinePlus related topics: Bedwetting Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

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 (Adult, Senior)
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

Locations


United States, Arizona
Urological Associates of Southern Arizona
Tucson, Arizona, United States, 85715
United States, California
Kaiser Permanente Southern California-Irvine Medical Center
Irvine, California, United States, 92618
Univeristy of California- Irvine
Orange, California, United States, 92868
The University of California- of San Diego
San Diego, California, United States, 92121
United States, Colorado
Urology Associates, PC
Englewood, Colorado, United States, 80113
United States, Florida
Specialists in Urology
Naples, Florida, United States, 34102
The Florida Bladder Institute
Naples, Florida, United States, 34109
United States, Illinois
Northwestern University Prentice Women's Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Deaconess Clinic
Newburgh, Indiana, United States, 47630
United States, Michigan
The University of Michigan Health Center
Ann Arbor, Michigan, United States, 48109
Mercy Heatlh Partners at the Lakes
Muskegon, Michigan, United States, 49444
United States, New York
Western New York Urology
Cheektowaga, New York, United States, 14225
United States, North Carolina
Western Carolina Women's Specialty Center
Asheville, North Carolina, United States, 28806
Carolina Urology Partners
Gastonia, North Carolina, United States, 28054
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Southern Urogynecology
Columbia, South Carolina, United States, 29169
United States, Virginia
The Female Pelvic Medicine Institute of Virginia, P.C.
Chesterfield, Virginia, United States, 23235
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
United States, Washington
Athena Urology
Issaquah, Washington, United States, 98027

Sponsors and Collaborators

Uroplasty, Inc

More Information


Responsible Party:	Uroplasty, Inc
ClinicalTrials.gov Identifier:	NCT01115465 History of Changes
Other Study ID Numbers:	MPQ092006
Study First Received:	April 30, 2010
Last Updated:	January 13, 2016
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 Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms	Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016

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