Effect of Deep Brain Stimulation on Lower Urinary Tract Function

Movement Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610233
• Other study ID #: KEK 33/05
• Secondary ID: 1005
• Status: Completed
• Phase: N/A
• First received: January 24, 2008
• Last updated: September 18, 2014
• Start date: June 2005
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with deep brain stimulation (DBS)

Exclusion Criteria:

• Pregnancy

• Age <18 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Movement Disorder
• Movement Disorders
• Urinary Tract Disease
• Urologic Diseases

Intervention

Procedure:
• deep brain stimulation ON
deep brain stimulation in the ON state
• Deep brain stimulation OFF
Urodynamic investigation with deep brain stimulation in the OFF state

Locations

Country	Name	City	State
Switzerland	Department of Neurology, University of Bern	Bern
Switzerland	Department of Urology, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of deep brain stimulation (DBS) on urodynamic parameters		immediately and 3 months after study inclusion	No
Secondary	Changes in questionnaire data due to deep brain stimulation (DBS)		3 months	No