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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00610233
Other study ID # KEK 33/05
Secondary ID 1005
Status Completed
Phase N/A
First received January 24, 2008
Last updated September 18, 2014
Start date June 2005
Est. completion date June 2014

Study information

Verified date September 2014
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with deep brain stimulation (DBS)

Exclusion Criteria:

- Pregnancy

- Age <18 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
deep brain stimulation ON
deep brain stimulation in the ON state
Deep brain stimulation OFF
Urodynamic investigation with deep brain stimulation in the OFF state

Locations

Country Name City State
Switzerland Department of Neurology, University of Bern Bern
Switzerland Department of Urology, University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of deep brain stimulation (DBS) on urodynamic parameters immediately and 3 months after study inclusion No
Secondary Changes in questionnaire data due to deep brain stimulation (DBS) 3 months No
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