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

This study has been completed.
Information provided by (Responsible Party):
Contura Identifier:
First received: June 1, 2006
Last updated: February 14, 2014
Last verified: July 2013
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: 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

Resource links provided by NLM:

Further study details as provided by Contura:

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

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

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)
Arms Assigned Interventions
Experimental: Bulkamid
Submucosal injection of Bulkamid into urethra
Device: Bulkamid
initial injection with option for second (if required)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00333073

Skejby Sygehus
Aarhus, Denmark
KAS Glostrup
Glostrup, Denmark
Helsinki University Central Hospital
Helsinki, Finland
DRK Gemeinnützige Krankenhaus Gmbh
Chemnitz, Germany
Karolinska Institutet
Stockholm, Sweden
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
Principal Investigator: Gunnar Lose, Prof., MD KAS Glostrup
  More Information

Additional Information:
Responsible Party: Contura Identifier: NCT00333073     History of Changes
Other Study ID Numbers: CONSUI-EU02
Study First Received: June 1, 2006
Last Updated: February 14, 2014

Keywords provided by Contura:
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders processed this record on September 25, 2017