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

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688506
• Other study ID #: KEK 292/07
• Secondary ID: 1492
• Status: Completed
• Phase: N/A
• First received: May 29, 2008
• Last updated: July 2, 2012
• Start date: November 2009
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Somatoform Disorders
• Syndrome

Intervention

Device:
• 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

Locations

Country	Name	City	State
Switzerland	Department of Urology, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Brain activity assessed by functional MRI		before treatment, after 12 weeks of treatment	No
Secondary	Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database		before treatment	No