NCT00610233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

9 years

First QC Date

January 24, 2008

Last Update Submit

September 18, 2014

Conditions

Movement DisorderUrinary Tract Disease

Keywords

deep brain stimulationurodynamics

Outcome Measures

Primary Outcomes (1)

  • Effect of deep brain stimulation (DBS) on urodynamic parameters

    immediately and 3 months after study inclusion

Secondary Outcomes (1)

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

    3 months

Study Arms (2)

A

ACTIVE COMPARATOR

Urodynamic investigation with deep brain stimulation ON

Procedure: deep brain stimulation ON

B

EXPERIMENTAL

Urodynamics with deep brain stimulation OFF

Procedure: Deep brain stimulation OFF

Interventions

deep brain stimulation ONPROCEDURE

deep brain stimulation in the ON state

A
Deep brain stimulation OFFPROCEDURE

Urodynamic investigation with deep brain stimulation in the OFF state

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with deep brain stimulation (DBS)

You may not qualify if:

  • Pregnancy
  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neurology, University of Bern

Bern, 3010, Switzerland

Location

Department of Urology, University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Movement DisordersUrologic Diseases

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Thomas M Kessler, MD

    Department of Urology, University of Bern, 3010 Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

June 1, 2005

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

CH(2)