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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00333073
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Urinary Incontinence Device: Bulkamid

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Bulkamid® as Bulking Agent for the Treatment of Female Urinary Incontinence
Study Start Date : March 2006
Primary Completion Date : October 2008
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bulkamid
Submucosal injection of Bulkamid into urethra
Device: Bulkamid
initial injection with option for second (if required)


Outcome Measures

Primary Outcome Measures :
  1. Subjective responder rate after 12 months follow-up [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. ICIQ [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ]
  2. 24 hour urine leakage [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ]
  3. daily incidence of incontinence episodes [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ]
  4. Qol [ Time Frame: Baseline, treatment, 1-, 6-, 12- and 24-months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333073


Locations
Denmark
Skejby Sygehus
Aarhus, Denmark
KAS Glostrup
Glostrup, Denmark
Finland
Helsinki University Central Hospital
Helsinki, Finland
Germany
DRK Gemeinnützige Krankenhaus Gmbh
Chemnitz, Germany
Sweden
Karolinska Institutet
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
United Kingdom
Worthing Hospital
Worthing, West Sussex, United Kingdom
Birmingham Women´s Hospital
Birmingham, United Kingdom
University Hospital of Hartlepool
Hartlepool, United Kingdom
St. George´s Hospital
London, United Kingdom
Sponsors and Collaborators
Contura
Investigators
Principal Investigator: Gunnar Lose, Prof., MD KAS Glostrup
More Information

Additional Information:
Responsible Party: Contura
ClinicalTrials.gov Identifier: NCT00333073     History of Changes
Other Study ID Numbers: CONSUI-EU02
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: February 17, 2014
Last Verified: July 2013

Keywords provided by Contura:
urinary incontinence
Bulkamid

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders