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Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710073
First Posted: July 3, 2008
Last Update Posted: July 3, 2008
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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sono-Electro-Magnetic Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Pilot Study

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 weeks of treatment, if effective also after 12 weeks of treatment ]

Secondary Outcome Measures:
  • Pain visual analogue scale [ Time Frame: before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment ]

Enrollment: 12
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Combined sono-electro-magnetic therapy
Device: sono-electro-magnetic therapy (Sonodyn Medico Star)
twice a day for 10 minutes during 6 or 12 weeks
Other Name: Sonodyn Medico Star

  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
  • age <18 years
  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): NCT00710073


Locations
Switzerland
Department of Urology, Bern University Hospital
Bern, Switzerland
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: Thomas M. Kessler, MD, Department of Urology, University of Bern, 3010 Bern
ClinicalTrials.gov Identifier: NCT00710073     History of Changes
Other Study ID Numbers: KEK99_06
First Submitted: July 2, 2008
First Posted: July 3, 2008
Last Update Posted: July 3, 2008
Last Verified: July 2008

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

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