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Effect of Deep Brain Stimulation on Lower Urinary Tract Function

Primary Purpose

Movement Disorder, Urinary Tract Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
deep brain stimulation ON
Deep brain stimulation OFF
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Movement Disorder focused on measuring deep brain stimulation, urodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with deep brain stimulation (DBS)

Exclusion Criteria:

  • Pregnancy
  • Age <18 years

Sites / Locations

  • Department of Neurology, University of Bern
  • Department of Urology, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Urodynamic investigation with deep brain stimulation ON

Urodynamics with deep brain stimulation OFF

Outcomes

Primary Outcome Measures

Effect of deep brain stimulation (DBS) on urodynamic parameters

Secondary Outcome Measures

Changes in questionnaire data due to deep brain stimulation (DBS)

Full Information

First Posted
January 24, 2008
Last Updated
September 18, 2014
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT00610233
Brief Title
Effect of Deep Brain Stimulation on Lower Urinary Tract Function
Official Title
Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorder, Urinary Tract Disease
Keywords
deep brain stimulation, urodynamics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Urodynamic investigation with deep brain stimulation ON
Arm Title
B
Arm Type
Experimental
Arm Description
Urodynamics with deep brain stimulation OFF
Intervention Type
Procedure
Intervention Name(s)
deep brain stimulation ON
Intervention Description
deep brain stimulation in the ON state
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation OFF
Intervention Description
Urodynamic investigation with deep brain stimulation in the OFF state
Primary Outcome Measure Information:
Title
Effect of deep brain stimulation (DBS) on urodynamic parameters
Time Frame
immediately and 3 months after study inclusion
Secondary Outcome Measure Information:
Title
Changes in questionnaire data due to deep brain stimulation (DBS)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with deep brain stimulation (DBS) Exclusion Criteria: Pregnancy Age <18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Kessler, MD
Organizational Affiliation
Department of Urology, University of Bern, 3010 Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Department of Urology, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Effect of Deep Brain Stimulation on Lower Urinary Tract Function

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