Brain Effects of Sacral Neuromodulation

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00610064
First received: January 24, 2008
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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).


Condition Intervention
Urinary Tract Disease
Radiation: Baseline neuroimaging
Radiation: Neuroimaging during sacral neuromodulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Effect of sacral neuromodulation on brain activity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Baseline neuroimaging
Radiation: Baseline neuroimaging
Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
B
Neuroimaging during sacral neuromodulation
Radiation: Neuroimaging during sacral neuromodulation
Neuroimaging during sacral neuromodulation using PET

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Age <18 years
  • Claustrophobia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00610064

Locations
Switzerland
Department of Urology, University of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Thomas M Kessler, MD Department of Urology, University of Bern, 3010 Switzerland
  More Information

No publications provided

Responsible Party: Thomas M. Kessler, MD, Department of Urology, University of Bern, 3010 Bern
ClinicalTrials.gov Identifier: NCT00610064     History of Changes
Other Study ID Numbers: KEK80_05, 1025
Study First Received: January 24, 2008
Last Updated: February 4, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Refractory lower urinary tract dysfunction
Sacral neuromodulation
Brain effects
Neuroimaging
Neuromodulation

Additional relevant MeSH terms:
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014