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Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688506
First Posted: June 3, 2008
Last Update Posted: July 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Brain activity assessed by functional MRI [ Time Frame: before treatment, after 12 weeks of treatment ]
  • Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database [ Time Frame: before treatment ]

Enrollment: 60
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Combined sono-electro-magnetic therapy
Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
Other Name: Sonodyn Medico Star
Placebo Comparator: 2
placebo therapy
Device: placebo therapy (Placebo Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
Other Name: Placebo Sonodyn Medico Star device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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): NCT00688506


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas M. Kessler, MD, Department of Urology, University of Bern, 3010 Bern
ClinicalTrials.gov Identifier: NCT00688506     History of Changes
Other Study ID Numbers: KEK 292/07
1492
First Submitted: May 29, 2008
First Posted: June 3, 2008
Last Update Posted: July 3, 2012
Last Verified: July 2012

Keywords provided by University Hospital Inselspital, Berne:
Chronic pelvic pain syndrome
Neuromodulation
Brain effects
Neuroimaging

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Pelvic Pain
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms