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

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

Sono-Electro-Magnetic Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710073
• Other study ID #: KEK99_06
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: July 2, 2008
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2008
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• 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

• age <18 years

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• sono-electro-magnetic therapy (Sonodyn Medico Star)
twice a day for 10 minutes during 6 or 12 weeks

Locations

Country	Name	City	State
Switzerland	Department of Urology, Bern University Hospital	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 weeks of treatment, if effective also after 12 weeks of treatment	No
Secondary	Pain visual analogue scale		before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment	No