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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00688506
First received: May 29, 2008
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Pelvic Pain
U.S. FDA Resources

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 ]
  • Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database [ Time Frame: before treatment ] [ Designated as safety issue: No ]

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

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

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

No publications provided

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
Study First Received: May 29, 2008
Last Updated: July 2, 2012
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Pelvic Pain
Somatoform Disorders
Pain
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013