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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014