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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 because the information has not been verified recently.
Verified August 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00770406
First received: October 9, 2008
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  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
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Soren Brostrom, MD, PhD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov 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:
Urination Disorders
Urinary Incontinence
Urinary Incontinence, Urge
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013