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Effect of Deep Brain Stimulation on Lower Urinary Tract Function

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ClinicalTrials.gov Identifier: NCT00610233
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : September 19, 2014
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

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
Movement Disorder Urinary Tract Disease Procedure: deep brain stimulation ON Procedure: Deep brain stimulation OFF Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : June 2005
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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




Primary Outcome Measures :
  1. Effect of deep brain stimulation (DBS) on urodynamic parameters [ Time Frame: immediately and 3 months after study inclusion ]

Secondary Outcome Measures :
  1. Changes in questionnaire data due to deep brain stimulation (DBS) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with deep brain stimulation (DBS)

Exclusion Criteria:

  • Pregnancy
  • Age <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610233


Locations
Switzerland
Department of Neurology, University of Bern
Bern, Switzerland, 3010
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

Responsible Party: Thomas M. Kessler, MD, Department of Urology, University of Bern, 3010 Switzerland
ClinicalTrials.gov Identifier: NCT00610233     History of Changes
Other Study ID Numbers: KEK 33/05
1005
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by University Hospital Inselspital, Berne:
deep brain stimulation
urodynamics

Additional relevant MeSH terms:
Movement Disorders
Urologic Diseases
Central Nervous System Diseases
Nervous System Diseases