Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge 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. Identifier: NCT00770406
Recruitment Status : Unknown
Verified August 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
First Posted : October 10, 2008
Last Update Posted : August 4, 2009
Information provided by:
Glostrup University Hospital, Copenhagen

Brief Summary:
A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.

Condition or disease Intervention/treatment Phase
Urge Urinary Incontinence Drug: botulinum toxin type A Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : January 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: botulinum toxin type A
    100 or 200 units intravesically

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

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

Inclusion Criteria:

  • refractory urge urinary incontinence

Exclusion Criteria:

  • neurological disease
  • pregnant or lactating
  • bladder neoplasias

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 identifier (NCT number): NCT00770406

Contact: Soren Brostrom, MD, PhD +45-43232243

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

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

Additional relevant MeSH terms:
Urinary Incontinence
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
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