Shocking Therapy for Chronic Pelvic Pain Syndrome

Chronic Prostatitis With Chronic Pelvic Pain Syndrome Clinical Trial

— CPPS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01828996
• Other study ID #: CAN-SW-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Shock wave therapy
A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.
• Placebo
A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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