Clinical trial NCT01115465: Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
Official title: Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
silicone elastomer
Lead sponsor: Uroplasty, Inc
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 5-years
Secondary outcomes:
measure: To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.
timeFrame: 5-years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Irvine
country: United States
facility: Kaiser Permanente Southern California-Irvine Medical Center
state: California
city: Orange
country: United States
facility: Univeristy of California- Irvine
state: California
city: San Diego
country: United States
facility: The University of California- of San Diego
state: California
city: Englewood
country: United States
facility: Urology Associates, PC
state: Colorado
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Naples
country: United States
facility: The Florida Bladder Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University Prentice Women's Hospital
state: Illinois
city: Newburgh
country: United States
facility: Deaconess Clinic
state: Indiana
city: Ann Arbor
country: United States
facility: The University of Michigan Health Center
state: Michigan
city: Muskegon
country: United States
facility: Mercy Heatlh Partners at the Lakes
state: Michigan
city: Cheektowaga
country: United States
facility: Western New York Urology
state: New York
city: Asheville
country: United States
facility: Western Carolina Women's Specialty Center
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Issaquah
country: United States
facility: Athena Urology
state: Washington
Study officials:
References: