Shocking Therapy for Chronic Pelvic Pain Syndrome (CPPS)

Mount Sinai Hospital, Canada

Status: Unknown

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Treatments: Device: Shock wave therapy; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01828996

CAN-SW-001

Details and patient eligibility

About

Chronic prostatitis/chronic pelvic pain syndrome is an extremely common urologic diagnosis and accounts for approximately 2 million outpatient visits to urology practices in the United States alone. Up to 6% of men in Canada recently experienced at least moderate to severe prostatitis-like symptoms with two thirds having symptoms lasting more than one year. There are a myriad of therapies for prostatitis, some of which work on some of the men but none works for all the men. Recently, a number of centres have been using low energy shock waves applied on the skin to target the prostate and the muscles around the prostate. The initial reports showed a significant reduction in the pain experienced by the men with prostatitis. However, this potentially highly promising therapy has not been widely used at least in part due to a lack of properly designed studies to validate this therapy. The investigators plan a randomized control trial using shock wave therapy on men with prostatitis. The goal is to provide some solid evidence that either shock waves are or are not of clinical benefit.

The investigators hypothesize men with chronic prostatitis/ chronic pelvic pain syndrome will have a reduction in pain and improved voiding and sexual function following low power transdermal shock wave therapy to the prostate and surrounding pelvic muscles.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Exhibit symptoms of pain typical for prostatitis/CPPS
• Have had the symptoms for at least 3 months
• Have no evidence of infection in the urine or expressed prostatic secretions (the seminal plasma may be substituted if expressed prostatic secretions are not available).
• Have failed at least one therapy for CPPS

Exclusion criteria

• Suspected or confirmed to have prostate cancer
• Have a coagulation disorders
• Use anticoagulants
• Have thrombosis
• Have used cortisone therapy up to 6 weeks before first treatment
• Are actively trying to conceive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Shock wave therapy

Active Comparator group

Description:

This group of patient will be treated with the shock wave head in the first 4 sessions then crossover to have the stand-off placebo for another 4 sessions.

Treatment:

Device: Placebo

Device: Shock wave therapy

Placebo

Placebo Comparator group

Description:

This group of patient will be treated with the stand-off placebo for the first 4 sessions then crossover to have the shock wave head in the other 4 sessions .

Treatment:

Device: Placebo

Device: Shock wave therapy