Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome
July 2, 2012 updated by: University Hospital Inselspital, Berne
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Bern, Switzerland, 3010
- Department of Urology, University of Bern
-
-
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
- prostate cancer
- age <18 years
- claustrophobia
- pacemaker, neurostimulator, insulin / pain pump
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Combined sono-electro-magnetic therapy
|
twice a day for 10 minutes during 12 weeks
Other Names:
|
|
Placebo Comparator: 2
placebo therapy
|
twice a day for 10 minutes during 12 weeks
Other Names:
|
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 and 12 weeks of treatment as well as 4 weeks after stop of treatment
|
before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brain activity assessed by functional MRI
Time Frame: before treatment, after 12 weeks of treatment
|
before treatment, after 12 weeks of treatment
|
|
Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database
Time Frame: before treatment
|
before treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2009
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
May 29, 2008
First Submitted That Met QC Criteria
June 2, 2008
First Posted (Estimate)
June 3, 2008
Study Record Updates
Last Update Posted (Estimate)
July 3, 2012
Last Update Submitted That Met QC Criteria
July 2, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK 292/07
- 1492 (CSL Behring)
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.