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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00710073
First received: July 2, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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 weeks of treatment, if effective also after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain visual analogue scale [ Time Frame: before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment ] [ Designated as safety issue: No ]

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

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
  • age <18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 22, 2013