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The aim of the study is to investigate and compare the treatment efficacy and safety of ESWT vs sham treatment for CP/CPPS patients.This is a triple-blind, randomized, parallel group sham-controlled clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Sham Comparator | Sham group |
|
| B | Active Comparator | LiST active treatment group |
|
| C | Active Comparator | LiST active treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dornier Aries 2 device | Device | • Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special pain domain (items 1-4) and the score for this domain ranges from 0 to 21. | from baseline to 12 weeks after final treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9) | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Hatzichristou, Prof. | Institute for the Study of Urological Diseases, Thessaloniki, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G.Gennimatas Hospital | Thessaloniki | 54621 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19372000 | Background | Zimmermann R, Cumpanas A, Miclea F, Janetschek G. Extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome in males: a randomised, double-blind, placebo-controlled study. Eur Urol. 2009 Sep;56(3):418-24. doi: 10.1016/j.eururo.2009.03.043. Epub 2009 Mar 25. | |
| 28119778 | Background | Al Edwan GM, Muheilan MM, Atta ON. Long term efficacy of extracorporeal shock wave therapy [ESWT] for treatment of refractory chronic abacterial prostatitis. Ann Med Surg (Lond). 2017 Jan 6;14:12-17. doi: 10.1016/j.amsu.2016.12.051. eCollection 2017 Feb. |
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| Dornier Aries 2 device | Device | LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7) |
|
| Dornier Aries 2 device | Device | LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7) |
|
| baseline, 4 and 12 weeks after final treatment |
| The difference between the LiST and sham group in the change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special urinary symptom domain (items 5-6) and the score for this domain ranges from 0 to 10. | from baseline to 4 and 12 weeks after final treatment |
| The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score | CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special quality of life domain (items 7-9) and the score for this domain ranges from 0 to 12. | from baseline to 4 and 12 weeks after final treatment |
| The difference between the LiST and sham group in the change of IIEF-ED score | It will be assessed by International Index of Erectile Function -Erectile Domain (IEF-ED) score. A questionnaire designed to evaluate erectile capabilities. The questionnaire provides a score between 5 and 30.The severity categories are: 1-10 severe ED, 10-16 moderate ED, 17-21 moderate to mild ED, 22-25 mild ED, 26-30 no ED | from baseline to 4 weeks after final treatment. |
| The difference between the LiST and sham group in the change of IPSS | They will be assessed by the International Prostate Symptom Score (IPSS). A questionnaire designed to provide information on lower urinary tract symptoms and their impact on quality of life. Scores range from 0 to 35. The severity categories are: 1-7 mild, 8-19 moderate, 20-35 severe | from baseline to 4 weeks after final treatment. |
| The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR) | Qmax will be measured by uroflowmetry/ PVR will be measured by ultrasound | from baseline to 4 weeks after final treatment. |
| The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains | from baseline to 4 weeks after final treatment. |
| The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS) | It will be assessed by the pain VAS, right after each LIST session. Pain VAS is a unidimensional measure of pain intensity . It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]. To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) | at week 3, 4, 5, 6, 7 and 8 |
| Changes in mpMRI of the prostate | baseline and 12 weeks after treatment |
| Adverse events rate in all patients | Potential treatment related adverse events after the first LIST session and during the 3 month follow up period will be reported | 18 weeks |