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Effect of Deep Brain Stimulation on Lower Urinary Tract Function

This study is currently recruiting participants.
Verified June 2012 by University Hospital Inselspital, Berne
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00610233
First received: January 24, 2008
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Movement Disorder
Urinary Tract Disease
 Procedure: deep brain stimulation ON
Procedure: Deep brain stimulation OFF

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Effect of deep brain stimulation (DBS) on urodynamic parameters [ Time Frame: immediately and 3 months after study inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in questionnaire data due to deep brain stimulation (DBS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with deep brain stimulation (DBS)

Exclusion Criteria:

  • Pregnancy
  • Age <18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610233

Contacts
Contact: Thomas M Kessler, MD 0041 31 632 20 45 tkessler@gmx.ch
Contact: Livio Mordasini, MD 0041 31 632 20 45 livio.mordasini@insel.ch

Locations
Switzerland
Department of Urology, University of Bern Recruiting
Bern, Switzerland, 3010
Contact: Livio Mordasini, MD     0041 31 632 20 45     livio.mordasini@insel.ch    
Principal Investigator: Thomas M Kessler, MD            
Department of Neurology, University of Bern Recruiting
Bern, Switzerland, 3010
Contact: Alain Kaelin-Lang, MD     0041 632 21 11     alain.kaelin@insel.ch    
Sub-Investigator: Alain Kaelin-Lang, MD            
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Thomas M Kessler, MD Department of Urology, University of Bern, 3010 Switzerland
  More Information

No publications provided

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
Study First Received: January 24, 2008
Last Updated: June 26, 2012
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on May 23, 2013