Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence
Sponsor
Glostrup University Hospital, Copenhagen (Other)
Overall Status
Unknown status
CT.gov ID
NCT00770406
Collaborator
(none)
20
1
17
1.2
Study Details
Study Description
Brief Summary
A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Jan 1, 2009
Anticipated Primary Completion Date
:
Jun 1, 2010
Anticipated Study Completion Date
:
Jun 1, 2010
Outcome Measures
Primary Outcome Measures
- Incontinence episode frequency [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Glostrup Hospital | Glostrup | Copenhagen | Denmark | DK-2600 |
Sponsors and Collaborators
- Glostrup University Hospital, Copenhagen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00770406
Other Study ID Numbers:
- BTXA2008
First Posted:
Oct 10, 2008
Last Update Posted:
Aug 4, 2009
Last Verified:
Aug 1, 2009
Additional relevant MeSH terms: