Extracorporal Shock Wave TherapyNCT01714830
Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome
A study testing standars electromagnetic DUOLITH SD1 and turn off standars electromagnetic DUOLITH SD1 in people with Extracorporal Shock Wave Therapy and Chronic Non-bacterial Prostatitis, run by Isfahan University of Medical Sciences.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Extracorporal Shock Wave Therapy, Chronic Non-bacterial Prostatitis, Chronic Pelvic Pain Syndrome
- What is being tested?
- standars electromagnetic DUOLITH SD1 and turn off standars electromagnetic DUOLITH SD1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-addiction to drugs and narcotics.
- Chronic pelvic pain existence for more than three month and certain diagnosis of chronic non-bacterial / chronic pelvic pain syndrome.
- Signing an informed consent for treatment by ESWT
Who cannot join
- To be under treatment by another method at the beginning of the study
- Another diagnosis such as prostate cancer is suggested during work-up.
- Therapy plan alteration.
- Non-inclination to continue this project.
About this study
Official title: The Efficacy of Extracorporal Shock Wave Therapy on Symptoms Relief in Patients With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome
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 (CP/CPPS) 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 (7,8).
Read more
In general population, the prevalence of chronic pelvic pain syndrome is about 0.5 percent because many patients do not consider their symptoms as disease, while 6.3% 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 help(13,27). 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 Peyronie's 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 CP/CPPS (31).
The use of ESWT for the treatment of CP/CPPS 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 improvement(32).
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 CP/CPPS.
Read the 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 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.
- Conditions
- Extracorporal Shock Wave Therapy, Chronic Non-bacterial Prostatitis, Chronic Pelvic Pain Syndrome
- Being tested
- standars electromagnetic DUOLITH SD1, turn off standars electromagnetic DUOLITH SD1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standars electromagnetic DUOLITH SD1Device
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.
turn off standars electromagnetic DUOLITH SD1Device
In the control group, the same protocol is applied but with the probe being turned off.
| Study group | Role | What they receive |
|---|---|---|
| sham group | Sham comparator | the same protocol is applied but with the probe being turned off. Receives: Device: turn off standars electromagnetic DUOLITH SD1 |
| treatment group | Sham comparator | patients will be treated by ESWT once a week for 4 weeks Receives: Device: standars electromagnetic DUOLITH SD1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporal Shock Wave TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farshid Alizadeh, Isfahan University of Medical Sciences
- Investigators
- Farshid Alizadeh, pediatric urologist, Principal investigator, Isfahan University of Medical Sciense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714830
- Sponsor's protocol ID
- IsfahanUMS1
- Status last verified
- Oct 2012
- First submitted
- 12 Oct 2012
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Extracorporal Shock Wave Therapy on Symptoms Relief in Patients With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT01714830
- Acronym / sponsor ID
- IsfahanUMS1
- Conditions
- Extracorporal Shock Wave Therapy, Chronic Non-bacterial Prostatitis, Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (CP/CPPS) 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 (7,8).
In general population, the prevalence of chronic pelvic pain syndrome is about 0.5 percent because many patients do not consider their symptoms as disease, while 6.3% 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 help(13,27). 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 Peyronie's 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 CP/CPPS (31).
The use of ESWT for the treatment of CP/CPPS 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 improvement(32).
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 CP/CPPS.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham group | Sham comparator | Device: turn off standars electromagnetic DUOLITH SD1the same protocol is applied but with the probe being turned off. |
| treatment group | Sham comparator | Device: standars electromagnetic DUOLITH SD1patients will be treated by ESWT once a week for 4 weeks |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-addiction to drugs and narcotics.
- Chronic pelvic pain existence for more than three month and certain diagnosis of chronic non-bacterial / chronic pelvic pain syndrome.
- Signing an informed consent for treatment by ESWT
Key exclusion criteria (4 listed)
- To be under treatment by another method at the beginning of the study
- Another diagnosis such as prostate cancer is suggested during work-up.
- Therapy plan alteration.
- Non-inclination to continue this project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standars electromagnetic DUOLITH SD1In 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. | Device | treatment group |
| turn off standars electromagnetic DUOLITH SD1In the control group, the same protocol is applied but with the probe being turned off. | Device | sham group |
Primary outcome
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
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farshid Alizadeh, pediatric urologist principal investigator
Isfahan University of Medical Sciense
Questions about this trial
What is this clinical trial studying?
A study testing standars electromagnetic DUOLITH SD1 and turn off standars electromagnetic DUOLITH SD1 in people with Extracorporal Shock Wave Therapy and Chronic Non-bacterial Prostatitis, run by Isfahan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.