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

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ClinicalTrials.gov 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
Sponsor:
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



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


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


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

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

Responsible Party: Soren Brostrom, MD, PhD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov 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
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