Brain Effects of Sacral Neuromodulation

Overview

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).

Full Title of Study: “Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

Interventions

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

Arms, Groups and Cohorts

  • Other: A
    • Baseline neuroimaging
  • Other: B
    • Neuroimaging during sacral neuromodulation

Clinical Trial Outcome Measures

Primary Measures

  • Effect of sacral neuromodulation on brain activity
    • Time Frame: 2-8 weeks

Secondary 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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation Exclusion Criteria:
  • Pregnancy – Age <18 years – Claustrophobia
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University Hospital Inselspital, Berne
    • Provider of Information About this Clinical Study
      • Thomas M. Kessler, MD, Department of Urology, University of Bern, 3010 Bern
    • Overall Official(s)
      • Thomas M Kessler, MD, Principal Investigator, Department of Urology, University of Bern, 3010 Switzerland

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