Back to resultsSono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome
Primary Purpose
Chronic Pelvic Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
sono-electro-magnetic therapy (Sonodyn Medico Star)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain Syndrome focused on measuring Chronic pelvic pain syndrome, Neuromodulation
Eligibility 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
Sites / Locations
- Department of Urology, Bern University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Combined sono-electro-magnetic therapy
Outcomes
Primary Outcome Measures
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
Secondary Outcome Measures
Pain visual analogue scale
Full Information
NCT ID
NCT00710073
First Posted
July 2, 2008
Last Updated
July 2, 2008
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT00710073
Brief Title
Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome
Official Title
Sono-Electro-Magnetic Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain Syndrome
Keywords
Chronic pelvic pain syndrome, Neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Combined sono-electro-magnetic therapy
Intervention Type
Device
Intervention Name(s)
sono-electro-magnetic therapy (Sonodyn Medico Star)
Other Intervention Name(s)
Sonodyn Medico Star
Intervention Description
twice a day for 10 minutes during 6 or 12 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Pain visual analogue scale
Time Frame
before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Kessler, MD
Organizational Affiliation
Department of Urology, University of Bern, 3010 Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Bern University Hospital
City
Bern
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome
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