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Brain Effects of Sacral Neuromodulation

Primary Purpose

Urinary Tract Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Baseline neuroimaging
Neuroimaging during sacral neuromodulation
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urinary Tract Disease focused on measuring Refractory lower urinary tract dysfunction, Sacral neuromodulation, Brain effects, Neuroimaging, Neuromodulation

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation

Exclusion Criteria:

  • Pregnancy
  • Age <18 years
  • Claustrophobia

Sites / Locations

  • Department of Urology, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

Baseline neuroimaging

Neuroimaging during sacral neuromodulation

Outcomes

Primary Outcome Measures

Effect of sacral neuromodulation on brain activity

Secondary Outcome Measures

Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing

Full Information

First Posted
January 24, 2008
Last Updated
February 4, 2010
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT00610064
Brief Title
Brain Effects of Sacral Neuromodulation
Official Title
Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (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
Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of central afferent activity is considered critical to this therapeutic effect but the neural mechanisms are poorly understood. We hypothesize that SNM has a significant effect on brain activity detectable by positron emission tomography (PET).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Disease
Keywords
Refractory lower urinary tract dysfunction, Sacral neuromodulation, Brain effects, Neuroimaging, Neuromodulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Baseline neuroimaging
Arm Title
B
Arm Type
Other
Arm Description
Neuroimaging during sacral neuromodulation
Intervention Type
Radiation
Intervention Name(s)
Baseline neuroimaging
Intervention Description
Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
Intervention Type
Radiation
Intervention Name(s)
Neuroimaging during sacral neuromodulation
Intervention Description
Neuroimaging during sacral neuromodulation using PET
Primary Outcome Measure Information:
Title
Effect of sacral neuromodulation on brain activity
Time Frame
2-8 weeks
Secondary Outcome Measure Information:
Title
Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing
Time Frame
immediately and 2-8 weeks after study inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation Exclusion Criteria: Pregnancy Age <18 years Claustrophobia
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 Urology, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Brain Effects of Sacral Neuromodulation

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