An interventional study of Low intensity shockwave therapy in Chronic Pelvic Pain Syndrome and Chronic Non-bacterial Prostatitis Type IIIB, sponsored by Institute for the Study of Urological Diseases, Greece. Completed at 1 site in Greece. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Institute for the Study of Urological Diseases, Greece · Not applicable, Interventional, and Treatment
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.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Institute for the Study of Urological Diseases, Greece is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (1/week) by using Dornier Aries 2 shockwave machine (energy level 7)
Device: Low intensity shockwave therapy
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (2/week) by using Dornier Aries 2 shockwave machine (energy level 7)
Device: Low intensity shockwave therapy
LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7)
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.
Time frame: from baseline to 12 weeks after final treatment
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 18 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2020 to primary completion in Oct 2020, 7 months.
Of 110 non-industry interventional studies with no phase under Pelvic Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 7 months is below that.
Counting every sponsor, half of 114 studies reached it within 17 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Institute for the Study of Urological Diseases, Greece