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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT00710073
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
12
Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: sono-electro-magnetic therapy (Sonodyn Medico Star)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sono-Electro-Magnetic Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Pilot Study
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) [before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment]

    Secondary Outcome Measures

    1. Pain visual analogue scale [before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00710073
    Other Study ID Numbers:
    • KEK99_06
    First Posted:
    Jul 3, 2008
    Last Update Posted:
    Jul 3, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    Chronic pelvic pain syndrome
    Neuromodulation
    Additional relevant MeSH terms:
    Syndrome
    Pelvic Pain
    Somatoform Disorders

    Study Results

    No Results Posted as of Jul 3, 2008