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The study will include 50 chronic pelvic pain syndrome (CPPS) patients who will be randomised in 2 groups.
Group A (25 patients )will receive 6 LiST sessions with a frequency 1 session / week.
Group B (25 patients) will receive 6 LiST sessions with a frequency 2 sessions / week.
National Institutes of Health Chronic Prostatitis Symptom Index(NHI-CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-ED) questionnaires will be answered before and at 1 and 3 month follow up visit.
Adverse events will be reported during the treatment and follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (1/week) by using Dornier Aries 2 shockwave machine (energy level 7) |
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| Group B | Active Comparator | Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (2/week) by using Dornier Aries 2 shockwave machine (energy level 7) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity shockwave therapy | Device | LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 1.The difference between groups 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 groups 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, Professor | Institute for the Study of Urological Diseases, Thessaloniki, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G.Gennimatas Hospital | Thessaloniki | 54621 | Greece |
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| Time Frame: baseline, 4 and 12 weeks after final treatment |
| The difference between groups 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 groups 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 and 12 weeks after final treatment |
| The difference between groups 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 and 12 weeks after final treatment |
| The difference between groups 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, |
| 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 |