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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Chronic Pelvic Pain Syndrome

Treatments: Device: placebo therapy (Placebo Sonodyn Medico Star); Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)

Study type: Interventional

Funder types: Other

Identifiers

NCT00688506

1492

KEK 292/07

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Combined sono-electro-magnetic therapy

Treatment:

Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)

2

Placebo Comparator group

Description:

placebo therapy

Treatment:

Device: placebo therapy (Placebo Sonodyn Medico Star)