Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome

Not Applicable

Completed

• Conditions: Chronic Pelvic Pain Syndrome
• Interventions: Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star); Device: placebo therapy (Placebo Sonodyn Medico Star)

• Registration Number: NCT00688506
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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. 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

Not available

Study Timeline

• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Study Start: 2009-11
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-02
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	combined sono-electro-magnetic therapy (Sonodyn Medico Star)	Combined sono-electro-magnetic therapy
2	placebo therapy (Placebo Sonodyn Medico Star)	placebo therapy

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)	before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment

Secondary Outcome Measures

Name	Time	Method
Brain activity assessed by functional MRI	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	before treatment

Trial Locations

Locations (1)

Department of Urology, University of Bern; 🇨🇭 Bern, Switzerland