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Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Contura
ClinicalTrials.gov Identifier:
NCT00333073
First received: June 1, 2006
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period


Condition Intervention
Urinary Incontinence
 Device: Bulkamid

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Contura:

Primary Outcome Measures:
  • Subjective responder rate after 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICIQ [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]
  • 24 hour urine leakage [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]
  • daily incidence of incontinence episodes [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]
  • Qol [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: March 2006
Study Completion Date: May 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Bulkamid
    initial injection with option for second (if required)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Symptomatic stress or mixed urinary incontinence for at least 12 months
  • Having at least 1 incontinence episode per day over three days

Exclusion Criteria:

  • Regular or intermittent users of an urethral catheter
  • Pregnant women
  • Suffer from severe allergies or anaphylaxis
  • Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease
  • History of any cancer within the last 5 years
  • Previous surgery for the treatment of urinary incontinence, including bulking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333073

Sponsors and Collaborators
Contura
Investigators
Principal Investigator: Gunnar Lose, Prof., MD KAS Glostrup
  More Information

Additional Information:
Bulkamid Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Contura
ClinicalTrials.gov Identifier: NCT00333073     History of Changes
Other Study ID Numbers: CONSUI-EU02
Study First Received: June 1, 2006
Last Updated: January 19, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Sweden: Regional Ethical Review Board
Germany: Ethics Commission
Finland: Ethics Committee
Austria: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Contura:
urinary incontinence
Bulkamid

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013