Brain Effects of Sacral Neuromodulation

NCT ID: NCT00610064

Last Updated: 2010-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Urinary Tract Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Baseline neuroimaging

Group Type OTHER

Baseline neuroimaging

Intervention Type RADIATION

Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation

B

Neuroimaging during sacral neuromodulation

Group Type OTHER

Neuroimaging during sacral neuromodulation

Intervention Type RADIATION

Neuroimaging during sacral neuromodulation using PET

Interventions

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Baseline neuroimaging

Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation

Intervention Type RADIATION

Neuroimaging during sacral neuromodulation

Neuroimaging during sacral neuromodulation using PET

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Age \<18 years
* Claustrophobia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Department of Urology, University of Bern, 3010 Bern

Principal Investigators

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Thomas M Kessler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, University of Bern, 3010 Switzerland

Locations

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Department of Urology, University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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1025

Identifier Type: -

Identifier Source: secondary_id

KEK80_05

Identifier Type: -

Identifier Source: org_study_id

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