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

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Macroplastique
Sponsored by
Uroplasty, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress Urinary Incontinence, silicone elastomer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urological Associates of Southern Arizona
  • Kaiser Permanente Southern California-Irvine Medical Center
  • Univeristy of California- Irvine
  • The University of California- of San Diego
  • Urology Associates, PC
  • Specialists in Urology
  • The Florida Bladder Institute
  • Northwestern University Prentice Women's Hospital
  • Deaconess Clinic
  • The University of Michigan Health Center
  • Mercy Heatlh Partners at the Lakes
  • Western New York Urology
  • Western Carolina Women's Specialty Center
  • Carolina Urology Partners
  • University of Oklahoma
  • Oregon Health & Science University
  • Southern Urogynecology
  • Urology of Virginia
  • Athena Urology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Macroplastique

Arm Description

Macroplastique will be used for the treatment in an open-label, five year, post-market study

Outcomes

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.
To describe the incidence of additional or alternative treatments

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2010
Last Updated
March 9, 2020
Sponsor
Uroplasty, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01115465
Brief Title
Study of Macroplastique Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
Acronym
ROSE
Official Title
Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uroplasty, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress Urinary Incontinence, silicone elastomer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macroplastique
Arm Type
Other
Arm Description
Macroplastique will be used for the treatment in an open-label, five year, post-market study
Intervention Type
Device
Intervention Name(s)
Macroplastique
Other Intervention Name(s)
polydimethylsiloxane, PDMS
Intervention Description
Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
Primary Outcome Measure Information:
Title
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.
Description
To describe the incidence of additional or alternative treatments
Time Frame
5-years
Secondary Outcome Measure Information:
Title
To describe the incidence of genitourinary and treatment related adverse events, including transient symptoms associated with the injection procedure.
Description
To describe the incidence of genitourinary and treatment related adverse events
Time Frame
5-years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Urological Associates of Southern Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Kaiser Permanente Southern California-Irvine Medical Center
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Univeristy of California- Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
The University of California- of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Urology Associates, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Specialists in Urology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
The Florida Bladder Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34109
Country
United States
Facility Name
Northwestern University Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Deaconess Clinic
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
The University of Michigan Health Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mercy Heatlh Partners at the Lakes
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Western New York Urology
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
Western Carolina Women's Specialty Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Carolina Urology Partners
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Southern Urogynecology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Athena Urology
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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