Effect of Deep Brain Stimulation on Lower Urinary Tract Function

September 18, 2014 updated by: University Hospital Inselspital, Berne

Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Urology, University of Bern
      • Bern, Switzerland, 3010
        • Department of Neurology, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with deep brain stimulation (DBS)

Exclusion Criteria:

  • Pregnancy
  • Age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of deep brain stimulation (DBS) on urodynamic parameters
Time Frame: immediately and 3 months after study inclusion
immediately and 3 months after study inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in questionnaire data due to deep brain stimulation (DBS)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK 33/05
  • 1005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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