Ignite Creation Date:
2024-05-06 @ 1:01 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01714830
Status:
UNKNOWN
Last Update Posted:
2012-10-26
First Post:
2012-10-12
Brief Title:
Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis Chronic Pelvic Pain Syndrome
Sponsor:
Isfahan University of Medical Sciences
Organization:
Isfahan University of Medical Sciences
Study Overview
Official Title:
The Efficacy of Extracorporal Shock Wave Therapy on Symptoms Relief in Patients With Chronic Non-bacterial Prostatitis Chronic Pelvic Pain Syndrome
Status:
UNKNOWN
Status Verified Date:
2012-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic pelvic pain CPP can affect both sexes and lasts at least for 3 months CPP in women could be due to endometrioses ovarian cyst colitis etc making the correct diagnosis important 1-3 The most prevalent reason for CPP in men is non-bacterial chronic prostatitis and in many cases they are considered equivalent to each other 4
Chronic non-bacterial prostatitis is associated with pain in pelvic region and could be associated with other symptoms such as dysuria myalgia arthralgia chronic fatigue burning sensation in the urethra abdominal urine frequency and pain after ejaculation 4-6 Chronic prostatitis chronic pelvic pain syndrome CPCPPS is devided into two groups III A Type inflammatory and III B Non-inflammatory The difference between the two groups is the presence of leukocytes in prostatic secretions after prostate massage urine and semen 78
In general population the prevalence of chronic pelvic pain syndrome is about 05 percent because many patients do not consider their symptoms as disease while 63 of people may show symptoms 9-11
One of the most important challenges in the treatment of chronic prostatitis chronic pelvic pain syndrome is that its etiology is obscure and it is known as a multi-factorial syndrome The proposed explanations are infection psychological reasons autoimmunity and neuro-myospasm Hypotheses about endothelial cells defect and cardio vascular disease have also been proposed upon which the new therapies have been based
In duplex mapping study of prostatic vessels in two groups of healthy and chronic non-bacterial prostatitis people it was shown that there was a significant reduction in systolic flow in prostatic arteries in people who had chronic non-bacterial prostatitis and there was a direct association between pain and blood flow intensity suggesting chronic ischemia as a possible cause for pain 13 Pain in prostate without significant infection is the hallmark of chronic prostatitis chronic pelvic pain syndrome 5 In physical exam prostate or pelvic tenderness may be observed in half of the patients
The diagnosis of chronic prostatitis chronic pelvic pain syndrome is challenging No specific lab test exists for its detection Prostate specific antigen PSA level which is typically increased in acute infection is usually normal in this condition The diagnostic approach in these patients is based on ruling out other curable causes such as benign prostatic hyperplasia or bladder cancer 14-20
NIH Chronic Prostatitis Symptom Index NIH-CPSI is used to evaluate symptom severity and response to treatment in these patients A reduction of 4-6 points in the score is considered significant response to the treatment 21
There is no first line treatment for patients of chronic pelvic pain syndrome The use of anti-bacterial alpha-blockers or anti-inflammatory drug is logical However if the patient does not respond further administration is not helpful In non-responders combination of drugs or other non-medical methods should be considered 23-26
As discussed earlier blood flow reduction ischemia and disorders in endothelium of vessels may cause pain in these patients and methods to improve blow flow may help1327 One of these methods is extracorporeal shockwave therapy ESWT which is typically used for tendonitis acceleration in bone reunion and wound healing improvement in muscle movements through a reduction in passive muscular tonus increasing muscular range of motion after cerebrovascular accident CVA treatment of Peyronies disease and erectile dysfunction 28-30
Shoskes et al compared 24 chronic prostatitis patients with 11 controls in terms of vascular stiffness indexes of increased blood flow vasodilation and reactive vascular hyperemia using Endo-PAT 2000-Machine They showed that endothelial disorder and stiffness along with the risk of cardiovascular disorders are increased in CPCPPS 31
The use of ESWT for the treatment of CPCPPS has been evaluated in a few studies In a double-blind randomized control trial Zimmermann et al placed 60 patients with chronic pelvic pain syndrome from chronic non-bacterial prostatitis into two groups and treated one of them in 4 sessions with a frequency of 3000 per session The treatment group showed superior results in terms of symptom improvement32
In another study Zimmermann et al followed 34 patients with chronic pelvic pain syndrome after one four and twelve weeks post ESWT in terms of quality of life and pain reduction They showed that this method is useful and without any complications 33
Considering the promising results of the cited articles along with the paucity of data in this regard we decided to perform a double-blind sham-controlled study to evaluate the effectiveness of ESWT in CPCPPS
Chronic non-bacterial prostatitis is associated with pain in pelvic region and could be associated with other symptoms such as dysuria myalgia arthralgia chronic fatigue burning sensation in the urethra abdominal urine frequency and pain after ejaculation 4-6 Chronic prostatitis chronic pelvic pain syndrome CPCPPS is devided into two groups III A Type inflammatory and III B Non-inflammatory The difference between the two groups is the presence of leukocytes in prostatic secretions after prostate massage urine and semen 78
In general population the prevalence of chronic pelvic pain syndrome is about 05 percent because many patients do not consider their symptoms as disease while 63 of people may show symptoms 9-11
One of the most important challenges in the treatment of chronic prostatitis chronic pelvic pain syndrome is that its etiology is obscure and it is known as a multi-factorial syndrome The proposed explanations are infection psychological reasons autoimmunity and neuro-myospasm Hypotheses about endothelial cells defect and cardio vascular disease have also been proposed upon which the new therapies have been based
In duplex mapping study of prostatic vessels in two groups of healthy and chronic non-bacterial prostatitis people it was shown that there was a significant reduction in systolic flow in prostatic arteries in people who had chronic non-bacterial prostatitis and there was a direct association between pain and blood flow intensity suggesting chronic ischemia as a possible cause for pain 13 Pain in prostate without significant infection is the hallmark of chronic prostatitis chronic pelvic pain syndrome 5 In physical exam prostate or pelvic tenderness may be observed in half of the patients
The diagnosis of chronic prostatitis chronic pelvic pain syndrome is challenging No specific lab test exists for its detection Prostate specific antigen PSA level which is typically increased in acute infection is usually normal in this condition The diagnostic approach in these patients is based on ruling out other curable causes such as benign prostatic hyperplasia or bladder cancer 14-20
NIH Chronic Prostatitis Symptom Index NIH-CPSI is used to evaluate symptom severity and response to treatment in these patients A reduction of 4-6 points in the score is considered significant response to the treatment 21
There is no first line treatment for patients of chronic pelvic pain syndrome The use of anti-bacterial alpha-blockers or anti-inflammatory drug is logical However if the patient does not respond further administration is not helpful In non-responders combination of drugs or other non-medical methods should be considered 23-26
As discussed earlier blood flow reduction ischemia and disorders in endothelium of vessels may cause pain in these patients and methods to improve blow flow may help1327 One of these methods is extracorporeal shockwave therapy ESWT which is typically used for tendonitis acceleration in bone reunion and wound healing improvement in muscle movements through a reduction in passive muscular tonus increasing muscular range of motion after cerebrovascular accident CVA treatment of Peyronies disease and erectile dysfunction 28-30
Shoskes et al compared 24 chronic prostatitis patients with 11 controls in terms of vascular stiffness indexes of increased blood flow vasodilation and reactive vascular hyperemia using Endo-PAT 2000-Machine They showed that endothelial disorder and stiffness along with the risk of cardiovascular disorders are increased in CPCPPS 31
The use of ESWT for the treatment of CPCPPS has been evaluated in a few studies In a double-blind randomized control trial Zimmermann et al placed 60 patients with chronic pelvic pain syndrome from chronic non-bacterial prostatitis into two groups and treated one of them in 4 sessions with a frequency of 3000 per session The treatment group showed superior results in terms of symptom improvement32
In another study Zimmermann et al followed 34 patients with chronic pelvic pain syndrome after one four and twelve weeks post ESWT in terms of quality of life and pain reduction They showed that this method is useful and without any complications 33
Considering the promising results of the cited articles along with the paucity of data in this regard we decided to perform a double-blind sham-controlled study to evaluate the effectiveness of ESWT in CPCPPS
Detailed 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 025 mJoulsM2 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
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 025 mJoulsM2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None