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

July 2, 2008 updated by: University Hospital Inselspital, Berne

Sono-Electro-Magnetic Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland
        • Department of Urology, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Sonodyn Medico Star

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain visual analogue scale
Time Frame: before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment
before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

July 3, 2008

Last Update Submitted That Met QC Criteria

July 2, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK99_06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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