Effect of Deep Brain Stimulation on Lower Urinary Tract Function

NCT ID: NCT00610233

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Movement Disorder Urinary Tract Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Urodynamic investigation with deep brain stimulation ON

Group Type ACTIVE_COMPARATOR

deep brain stimulation ON

Intervention Type PROCEDURE

deep brain stimulation in the ON state

B

Urodynamics with deep brain stimulation OFF

Group Type EXPERIMENTAL

Deep brain stimulation OFF

Intervention Type PROCEDURE

Urodynamic investigation with deep brain stimulation in the OFF state

Interventions

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deep brain stimulation ON

deep brain stimulation in the ON state

Intervention Type PROCEDURE

Deep brain stimulation OFF

Urodynamic investigation with deep brain stimulation in the OFF state

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with deep brain stimulation (DBS)

Exclusion Criteria

* Pregnancy
* Age \<18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Department of Urology, University of Bern, 3010 Switzerland

Principal Investigators

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Thomas M Kessler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, University of Bern, 3010 Switzerland

Locations

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Department of Neurology, University of Bern

Bern, , Switzerland

Site Status

Department of Urology, University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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1005

Identifier Type: -

Identifier Source: secondary_id

KEK 33/05

Identifier Type: -

Identifier Source: org_study_id

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