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

ClinicalTrials.gov ID: NCT01115465

Public ClinicalTrials.gov record NCT01115465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 2:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Real-time Observation of Safety and Effectiveness in the Treatment of Female Stress Urinary Incontinence

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01115465
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Uroplasty, Inc
Industry
Enrollment
276 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2008 (Actual)
Primary completion
Dec 2021 (Estimated)
Completion
Feb 2022 (Estimated)
Last update posted
Mar 11, 2020

2008 – 2022

United States locations

U.S. sites
19
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Urological Associates of Southern Arizona Tucson Arizona 85715 —
Kaiser Permanente Southern California-Irvine Medical Center Irvine California 92618 —
Univeristy of California- Irvine Orange California 92868 —
The University of California- of San Diego San Diego California 92121 —
Urology Associates, PC Englewood Colorado 80113 —
Specialists in Urology Naples Florida 34102 —
The Florida Bladder Institute Naples Florida 34109 —
Northwestern University Prentice Women's Hospital Chicago Illinois 60611 —
Deaconess Clinic Newburgh Indiana 47630 —
The University of Michigan Health Center Ann Arbor Michigan 48109 —
Mercy Heatlh Partners at the Lakes Muskegon Michigan 49444 —
Western New York Urology Cheektowaga New York 14225 —
Western Carolina Women's Specialty Center Asheville North Carolina 28806 —
Carolina Urology Partners Gastonia North Carolina 28054 —
University of Oklahoma Oklahoma City Oklahoma 73104 —
Oregon Health & Science University Portland Oregon 97239 —
Southern Urogynecology Columbia South Carolina 29169 —
Urology of Virginia Virginia Beach Virginia 23462 —
Athena Urology Issaquah Washington 98027 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01115465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 11, 2020 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01115465 live on ClinicalTrials.gov.

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