- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710073
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
-
-
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Bern, Switzerland
- Department of Urology, Bern University Hospital
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-
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
|
twice a day for 10 minutes during 6 or 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 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.
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
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.