Effect of Deep Brain Stimulation on Lower Urinary Tract Function

This study is currently recruiting participants.

Verified December 2011 by University Hospital Inselspital, Berne

First Received on January 24, 2008. Last Updated on December 14, 2011 History of Changes

Sponsor:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00610233

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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Movement Disorders

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:	December 14, 2011
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 February 09, 2012