Effect of Deep Brain Stimulation on Lower Urinary Tract Function
Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT00610233
Collaborator
(none)
45
2
2
108
22.5
0.2
Study Details
Study Description
Brief Summary
The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique opportunity to investigate the role of different cerebral centers on LUT function.
We hypothesize that DBS has a significant effect on LUT function and that these effects depend on the specific stimulated cerebral center.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function
Study Start Date
:
Jun 1, 2005
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A Urodynamic investigation with deep brain stimulation ON |
Procedure: deep brain stimulation ON
deep brain stimulation in the ON state
|
| Experimental: B Urodynamics with deep brain stimulation OFF |
Procedure: Deep brain stimulation OFF
Urodynamic investigation with deep brain stimulation in the OFF state
|
Outcome Measures
Primary Outcome Measures
- Effect of deep brain stimulation (DBS) on urodynamic parameters [immediately and 3 months after study inclusion]
Secondary Outcome Measures
- Changes in questionnaire data due to deep brain stimulation (DBS) [3 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with deep brain stimulation (DBS)
Exclusion Criteria:
-
Pregnancy
-
Age <18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, University of Bern | Bern | Switzerland | 3010 | |
| 2 | Department of Urology, University of Bern | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Thomas M Kessler, MD, Department of Urology, University of Bern, 3010 Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00610233
Other Study ID Numbers:
- KEK 33/05
- 1005
First Posted:
Feb 7, 2008
Last Update Posted:
Sep 19, 2014
Last Verified:
Sep 1, 2014
Keywords provided by ,
,
Additional relevant MeSH terms: