Brain Effects of Sacral Neuromodulation - Full Text View

Purpose

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

ChemIDplus related topics:

BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Crossover Assignment, Efficacy Study

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610064

Contacts


Contact: Thomas M Kessler, MD	0041 31 632 20 45	tkessler@gmx.ch

Contact: Mirjam Huwyler, MD	0041 31 632 20 45	mirjam.huwyler@insel.ch

Locations


Switzerland
	Department of Urology, University of Bern	Recruiting
	Bern, Switzerland, 3010
	Contact: Mirjam Huwyler, MD 0041 31 632 20 45 mirjam.huwyler@insel.ch
	Principal Investigator: Thomas M Kessler, MD

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators


Principal Investigator:	Thomas M Kessler, MD	Department of Urology, University of Bern, 3010 Switzerland

More Information

Responsible Party:	Department of Urology, University of Bern, 3010 Bern ( Thomas M. Kessler, MD )
Study ID Numbers:	KEK80_05, 1025
First Received:	January 24, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00610064
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

Refractory lower urinary tract dysfunction

Sacral neuromodulation

Brain effects

Neuroimaging

Neuromodulation

Study placed in the following topic categories:

Urologic Diseases

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00610064