Combined Sono-Electro-Magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome - Full Text View

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00688506

Purpose

Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.

We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.

Condition	Intervention
Chronic Pelvic Pain Syndrome	Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star) Device: placebo therapy (Placebo Sonodyn Medico Star)

MedlinePlus related topics: Pelvic Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Combined Sono-Electro-Magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) [ Time Frame: before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brain activity assessed by functional MRI [ Time Frame: before treatment, after 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Combined sono-electro-magnetic therapy	Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star) twice a day for 10 minutes during 12 weeks
2: Placebo Comparator placebo therapy	Device: placebo therapy (Placebo Sonodyn Medico Star) twice a day for 10 minutes during 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CPSS III
symptomatic >3 months
NIH-CPSI total score =/>15
NIH-CPSI pain =/>8

Exclusion Criteria:

post void residual >100mL
urinary tract infection
urethral stricture
prostate cancer
age <18 years
claustrophobia
pacemaker, neurostimulator, insulin / pain pump

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688506

Contacts

Contact: Thomas M Kessler, MD	41-31-632-2045	tkessler@gmx.ch
Contact: George N Thalmann, MD	41-31-632-2045	george.thalmann@insel.ch

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

More Information

Responsible Party:	Department of Urology, University of Bern, 3010 Bern ( Thomas M. Kessler, MD )
Study ID Numbers:	KEK 292/07, 1492
Study First Received:	May 29, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00688506
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

Chronic pelvic pain syndrome
Neuromodulation
Brain effects
Neuroimaging

Study placed in the following topic categories:

Signs and Symptoms
Pelvic Pain
Mental Disorders
Pain
Somatoform Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009