Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome
NCT ID: NCT00688506
Last Updated: 2012-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-11-30
2012-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Combined sono-electro-magnetic therapy
combined sono-electro-magnetic therapy (Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
2
placebo therapy
placebo therapy (Placebo Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
Interventions
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combined sono-electro-magnetic therapy (Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
placebo therapy (Placebo Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptomatic \>3 months
* NIH-CPSI total score =/\>15
* NIH-CPSI pain =/\>8
Exclusion Criteria
* urinary tract infection
* urethral stricture
* prostate cancer
* age \<18 years
* claustrophobia
* pacemaker, neurostimulator, insulin / pain pump
18 Years
MALE
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Department of Urology, University of Bern, 3010 Bern
Principal Investigators
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Thomas M Kessler, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, University of Bern, 3010 Switzerland
Locations
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Department of Urology, University of Bern
Bern, , Switzerland
Countries
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References
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Kessler TM, Mordasini L, Weisstanner C, Juni P, da Costa BR, Wiest R, Thalmann GN. Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial. PLoS One. 2014 Dec 29;9(12):e113368. doi: 10.1371/journal.pone.0113368. eCollection 2014.
Other Identifiers
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1492
Identifier Type: -
Identifier Source: secondary_id
KEK 292/07
Identifier Type: -
Identifier Source: org_study_id