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Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

NCT00629083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2020-02-07

Study results available
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Summary

The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Bulkamid

Bulking injection with Bulkamid injection device

DEVICE

Contigen

Transurethral bulking injection

Sponsors & Collaborators

  • Regulatory and Clinical Research Institute Inc

    collaborator OTHER

  • Contura

    lead INDUSTRY

Principal Investigators

  • Silvia Garcia-Codony · Contura

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-05-31
Completion
2013-05-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • France

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 NCT00629083 on ClinicalTrials.gov