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The Efficacy of Extracorporal Shock Wave Therapy on Symptoms Relief in Patients With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome


N/A
20 Years
90 Years
Open (Enrolling)
Male
Extracorporal Shock Wave Therapy, Chronic Non-bacterial Prostatitis, Chronic Pelvic Pain Syndrome

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Trial Information

The Efficacy of Extracorporal Shock Wave Therapy on Symptoms Relief in Patients With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome


Eligible patients will sign an informed consent. Bacterial prostatitis will be ruled out by
a 2-glass test (In this method a mid-stream urine sample is collected (10 ml of urine is
discarded and the second 10 ml of urine is collected) and then prostate massage is done for
a minute by Digital Rectal Exam and then another 10 ml of urine is collected.

After briefing the patients about the method and obtaining written consent from, he will be
randomly allocated into either the treatment or control group.

In the first group patients will be treated by ESWT once a week for 4 weeks. (Each time 3000
impulses, with 0.25 mJouls/M2 and 3 Hertz of frequency. After each 500 pulses, the probe
position will be corrected, using trans-perineal ultrasound. The used device in this study
is the standars electromagnetic DUOLITH SD1- shock waves against erectile dysfunction.

In the control group, the same protocol is applied but with the probe being turned off.

The examination is performed in supine position for patient. For each patient, pelvic pain
intensity considering is performed at the beginning and end of study, by VAS. Patients are
considered by doctor for NIH index at the beginning and end of study.

Finally, obtained data about pain relief and change in NIH-CPSI are recorded in special
profile for each patient and finally are analyzed.


Inclusion Criteria:



1. Non-addiction to drugs and narcotics.

2. Chronic pelvic pain existence for more than three month and certain diagnosis of
chronic non-bacterial / chronic pelvic pain syndrome.

3. Signing an informed consent for treatment by ESWT

Exclusion Criteria:

1. To be under treatment by another method at the beginning of the study

2. Another diagnosis such as prostate cancer is suggested during work-up.

3. Therapy plan alteration.

4. Non-inclination to continue this project.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

effect of extracorporeal shock wave therapy on pain reduction according to visual analogue scale and NIH-CPSI scale in patients with chronic non-bacterial prostatitis / chronic pelvic pain syndrome

Outcome Description:

For each patient, pelvic pain intensity considering is performed at the beginning and end of study, by visual analogue scale(VAS). Patients are considered by doctor for NIH index according to NIH-CPSI scale at the beginning and end of study.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Farshid Alizadeh, pediatric urologist

Investigator Role:

Principal Investigator

Investigator Affiliation:

Isfahan University of Medical Sciense

Authority:

Iran: Ethics Committee

Study ID:

IsfahanUMS1

NCT ID:

NCT01714830

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Extracorporal Shock Wave Therapy
  • Chronic Non-bacterial Prostatitis
  • Chronic Pelvic Pain Syndrome
  • Pelvic Pain
  • Prostatitis
  • Shock
  • Somatoform Disorders

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