Shocking Therapy for Chronic Pelvic Pain Syndrome

Not Applicable

• Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Interventions: Device: Shock wave therapy; Device: Placebo

• Registration Number: NCT01828996
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Shock wave therapy	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 .
Shock wave therapy	Shock wave therapy	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.
Shock wave therapy	Placebo	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.
Placebo	Placebo	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 .

Primary Outcome Measures

Name	Time	Method
Changes in pain	32 weeks after entering into trial	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).

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada