Clinical Trial: A Sham Controlled Study of the Effects of Ultrasonic Shockwaves as a Treatment for Chronic Pelvic Pain

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Low Intensity Extracorporeal Shockwave Therapy Against Chronic Pelvic Pain: a Randomized and Sham Controled Study

Brief Summary:

Introduction:

Chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount of energy approximately 5 cm under the skin of the patient without damaging the skin. This have been shown to increase blood flow and accelerate healing which could also be beneficial in chronic pelvic pain patients.The purpose of this study is to investigate the effects of LIESWT on chronic pelvic pain.

Methods:

All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.

The investigators anticipate to include 100 chronic pelvic pain patients in the study.

included patients will be randomized into two groups: active treatment or sham treatment.

All patients will be required to provide a urine sample and a semen sample prior to final inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo a digital rectal exploration and finally all patients is required to provide an informed consent in order to be included in the study.

A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each treatment consists of 3000 shockwaves applied to the perineum with a energy density of 0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.

Detailed Summary:
Sponsor: Herlev Hospital

Current Primary Outcome: Change in NIH-Chronic Prostatitis Symptom Index [ Time Frame: Change from baseline to twelve weeks after final treatment ]

A questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain, urinary symptoms, and quality of life.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in The International Index of Erectile Function 5 [ Time Frame: Change from baseline to twelve weeks after final treatment ]
    Questionnaire designed to evaluate erectile capabilities. The questionnaire provides a score between 5 and 25.
  • Change in The International prostate symptom score [ Time Frame: Change from baseline to twelve weeks after final treatment ]
    A questionnaire designed to provide information on lower urinary tract symptoms and their impact on quality of life. scores range from 0 to 35.
  • Global satisfaction score [ Time Frame: Twelve weeks after final treatment ]
    One question designed to estimate treatment satisfaction on a four point Likert scale.


Original Secondary Outcome: Same as current

Information By: Herlev Hospital

Dates:
Date Received: January 10, 2014
Date Started: February 2014
Date Completion: February 2016
Last Updated: March 23, 2015
Last Verified: March 2015