Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome
Keywords
Abstract
Description
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.
Dates
Last Verified: | 09/30/2012 |
First Submitted: | 10/11/2012 |
Estimated Enrollment Submitted: | 10/22/2012 |
First Posted: | 10/25/2012 |
Last Update Submitted: | 10/22/2012 |
Last Update Posted: | 10/25/2012 |
Actual Study Start Date: | 07/31/2011 |
Estimated Primary Completion Date: | 10/31/2012 |
Condition or disease
Intervention/treatment
Device: treatment group
Device: sham group
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Sham Comparator: sham group the same protocol is applied but with the probe being turned off. | Device: sham group In the control group, the same protocol is applied but with the probe being turned off. |
Sham Comparator: treatment group patients will be treated by ESWT once a week for 4 weeks | Device: treatment 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. |
Eligibility Criteria
Ages Eligible for Study | 20 Years To 20 Years |
Sexes Eligible for Study | Male |
Accepts Healthy Volunteers | Yes |
Criteria | 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. |
Outcome
Primary Outcome Measures
1. 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 [12 months]