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Brain Effects of Sacral Neuromodulation

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ClinicalTrials.gov Identifier: NCT00610064
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : February 5, 2010
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

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).


Condition or disease Intervention/treatment Phase
Urinary Tract Disease Radiation: Baseline neuroimaging Radiation: Neuroimaging during sacral neuromodulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction
Study Start Date : October 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Effect of sacral neuromodulation on brain activity [ Time Frame: 2-8 weeks ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: February 2010

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

Additional relevant MeSH terms:
Urologic Diseases