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Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770406
First Posted: October 10, 2008
Last Update Posted: August 4, 2009
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.
Information provided by:
Glostrup University Hospital, Copenhagen
  Purpose
A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.

Condition Intervention Phase
Urge Urinary Incontinence Drug: botulinum toxin type A Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravesikal Instillation af Botulinum Toxin Type A Til Patienter Med Urge Urininkontinens

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Incontinence episode frequency [ Time Frame: 1 year ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: botulinum toxin type A
    100 or 200 units intravesically
  Eligibility

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:

  • refractory urge urinary incontinence

Exclusion Criteria:

  • neurological disease
  • pregnant or lactating
  • bladder neoplasias
  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): NCT00770406


Contacts
Contact: Soren Brostrom, MD, PhD +45-43232243 soren@brostrom.dk

Locations
Denmark
Glostrup Hospital Recruiting
Glostrup, Copenhagen, Denmark, DK-2600
Principal Investigator: Soren Brostrom, MD, PhD         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
  More Information

Responsible Party: Soren Brostrom, MD, PhD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier: NCT00770406     History of Changes
Other Study ID Numbers: BTXA2008
First Submitted: October 9, 2008
First Posted: October 10, 2008
Last Update Posted: August 4, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents