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

Primary Purpose

Urge Urinary Incontinence

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
botulinum toxin type A
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • refractory urge urinary incontinence

Exclusion Criteria:

  • neurological disease
  • pregnant or lactating
  • bladder neoplasias

Sites / Locations

  • Glostrup HospitalRecruiting

Outcomes

Primary Outcome Measures

Incontinence episode frequency

Secondary Outcome Measures

Full Information

First Posted
October 9, 2008
Last Updated
August 3, 2009
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00770406
Brief Title
Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence
Official Title
Intravesikal Instillation af Botulinum Toxin Type A Til Patienter Med Urge Urininkontinens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
botulinum toxin type A
Intervention Description
100 or 200 units intravesically
Primary Outcome Measure Information:
Title
Incontinence episode frequency
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: refractory urge urinary incontinence Exclusion Criteria: neurological disease pregnant or lactating bladder neoplasias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soren Brostrom, MD, PhD
Phone
+45-43232243
Email
soren@brostrom.dk
Facility Information:
Facility Name
Glostrup Hospital
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
DK-2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soren Brostrom, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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