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Clinical Trials/NCT01828996
NCT01828996
Unknown
N/A

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

Mount Sinai Hospital, Canada1 site in 1 country40 target enrollmentFebruary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Sponsor
Mount Sinai Hospital, Canada
Enrollment
40
Locations
1
Primary Endpoint
Changes in pain
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in pain

Time Frame: 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).

Study Sites (1)

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