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

NCT01115465 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2020-03-11

No results posted yet for this study

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).

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Macroplastique

Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).

Sponsors & Collaborators

  • Uroplasty, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2021-12-31
Completion
2022-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115465 on ClinicalTrials.gov