Brain Effects of Sacral Neuromodulation

February 4, 2010 updated by: University Hospital Inselspital, Berne

Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Urology, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Age <18 years
  • Claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: A
Baseline neuroimaging
Radiation: Baseline neuroimaging
Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
OTHER: B
Neuroimaging during sacral neuromodulation
Radiation: Neuroimaging during sacral neuromodulation
Neuroimaging during sacral neuromodulation using PET

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
immediately and 2-8 weeks after study inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (ESTIMATE)

February 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2010

Last Update Submitted That Met QC Criteria

February 4, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK80_05
  • 1025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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