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Shocking Therapy for Chronic Pelvic Pain Syndrome (CPPS)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01828996
First Posted: April 11, 2013
Last Update Posted: April 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
  Purpose

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.


Condition Intervention
Chronic Prostatitis With Chronic Pelvic Pain Syndrome Device: Shock wave therapy Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Shocking Therapy for Pelvic Pain: Evaluation of Shock Wave Therapy to Treat Chronic Pelvic Pain in Men

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • 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).



Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Other Name: Storz Duolith SD1
Device: 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
Other Name: Storz Duolith SD1 with stand-off head
Placebo Comparator: 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 .
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.
Other Name: Storz Duolith SD1
Device: 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
Other Name: Storz Duolith SD1 with stand-off head

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828996


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Keith Jarvi, MD Mount Sinai Hospital, Canada
  More Information

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01828996     History of Changes
Other Study ID Numbers: CAN-SW-001
First Submitted: March 4, 2013
First Posted: April 11, 2013
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Mount Sinai Hospital, Canada:
Chronic pelvic pain syndrome
Chronic prostatitis
Shock wave therapy
Prostate
Pelvic floor
Pain

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Pelvic Pain
Prostatitis
Chronic Disease
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes


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