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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Information provided by:
Glostrup University Hospital, Copenhagen Identifier:
First received: October 9, 2008
Last updated: August 3, 2009
Last verified: August 2009
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

Inclusion Criteria:

  • refractory urge urinary incontinence

Exclusion Criteria:

  • neurological disease
  • pregnant or lactating
  • bladder neoplasias
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Soren Brostrom, MD, PhD, Glostrup University Hospital,Copenhagen Identifier: NCT00770406     History of Changes
Other Study ID Numbers: BTXA2008 
Study First Received: October 9, 2008
Last Updated: August 3, 2009
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 26, 2016