Shocking Therapy for Chronic Pelvic Pain Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Shocking Therapy for Pelvic Pain: Evaluation of Shock Wave Therapy to Treat Chronic Pelvic Pain in Men

Conditions
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Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Device: Shock wave therapy
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shock wave therapy<br>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. | Device: Shock wave therapy<br>* A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.<br>* Other names: Storz Duolith SD1;Device: Placebo<br>* A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region<br>* Other names: Storz Duolith SD1 with stand-off head;|
| Placebo Comparator: Placebo<br>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 . | Device: Shock wave therapy<br>* A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.<br>* Other names: Storz Duolith SD1;Device: Placebo<br>* A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region<br>* Other names: Storz Duolith SD1 with stand-off head;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain | Changes in pain is measured by a visual analog scale from question 4 from the NIH- Chronic Prostatitis Symptom Index. The NIH-CPSI is a validated instrument used to measure and follow changes in pain, impact and bother from CPPS. We are calculating the changes from the last time point to the first time point (baseline). | 32 weeks after entering into trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pelvic pain syndrome, Chronic prostatitis, Shock wave therapy, Prostate, Pelvic floor, Pain