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NCT00770406 Clinical Trial

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

Urge Urinary Incontinence Clinical Trial

Official title:
Intravesikal Instillation af Botulinum Toxin Type A Til Patienter Med Urge Urininkontinens

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00770406
Other study ID # BTXA2008
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received October 9, 2008
Last updated August 3, 2009
Start date January 2009
Est. completion date June 2010

Study information
Verified date August 2009
Source Glostrup University Hospital, Copenhagen
Contact Soren Brostrom, MD, PhD
Phone +45-43232243
Email soren@brostrom.dk
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- refractory urge urinary incontinence

Exclusion Criteria:

- neurological disease

- pregnant or lactating

- bladder neoplasias

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Glostrup Hospital Glostrup Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incontinence episode frequency 1 year No
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