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Brain Effects of Sacral Neuromodulation

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

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
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 ]

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 ]

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
Baseline neuroimaging
Radiation: Baseline neuroimaging
Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
Neuroimaging during sacral neuromodulation
Radiation: Neuroimaging during sacral neuromodulation
Neuroimaging during sacral neuromodulation using PET


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Age <18 years
  • Claustrophobia
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Please refer to this study by its identifier: NCT00610064

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

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

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

Additional relevant MeSH terms:
Urologic Diseases processed this record on May 25, 2017