search
Back to results

Shocking Therapy for Chronic Pelvic Pain Syndrome (CPPS)

Primary Purpose

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Shock wave therapy
Placebo
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis With Chronic Pelvic Pain Syndrome focused on measuring Chronic pelvic pain syndrome, Chronic prostatitis, Shock wave therapy, Prostate, Pelvic floor, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Shock wave therapy

Placebo

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 4, 2013
Last Updated
March 8, 2019
Sponsor
Mount Sinai Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT01828996
Brief Title
Shocking Therapy for Chronic Pelvic Pain Syndrome
Acronym
CPPS
Official Title
Shocking Therapy for Pelvic Pain: Evaluation of Shock Wave Therapy to Treat Chronic Pelvic Pain in Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords
Chronic pelvic pain syndrome, Chronic prostatitis, Shock wave therapy, Prostate, Pelvic floor, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shock wave therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 .
Intervention Type
Device
Intervention Name(s)
Shock wave therapy
Other Intervention Name(s)
Storz Duolith SD1
Intervention Description
A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Storz Duolith SD1 with stand-off head
Intervention Description
A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region
Primary Outcome Measure Information:
Title
Changes in pain
Description
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).
Time Frame
32 weeks after entering into trial

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Jarvi, MD
Organizational Affiliation
Mount Sinai Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Shocking Therapy for Chronic Pelvic Pain Syndrome

We'll reach out to this number within 24 hrs