Shocking Therapy for Chronic Pelvic Pain Syndrome

NCT01828996 | Unknown

• 1 other identifier: CAN-SW-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Keywords

Chronic pelvic pain syndrome; Chronic prostatitis; Shock wave therapy; Prostate; Pelvic floor; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Shock wave therapy

ACTIVE COMPARATOR

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; Device: Placebo

Placebo

PLACEBO COMPARATOR

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; Device: Placebo

Interventions

Shock wave therapy DEVICE

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.

Also known as: Storz Duolith SD1

Placebo; Shock wave therapy

Placebo DEVICE

A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region

Also known as: Storz Duolith SD1 with stand-off head

Placebo; Shock wave therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Prostatitis; Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Keith Jarvi, MD

  Mount Sinai Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: April 11, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

CA (1)