An interventional study of Dornier Aries 2 device in Chronic Prostatitis With Chronic Pelvic Pain Syndrome, sponsored by Institute for the Study of Urological Diseases, Greece. Status unknown. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Institute for the Study of Urological Diseases, Greece · Not applicable, Interventional, and Treatment
The aim of the study is to investigate the efficacy and safety of LiST retreatment for CP/CPPS patients.A total of 50 patients with CP/CPPS diagnosis who were previously treated with 6 sessions of LiST will participate in this study.The primary study parameter is the CP/CPPS-related pain complaints and it will be assessed by the NIH-CPSI
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis 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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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.
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.
LiST active treatment group
Device: Dornier Aries 2 device
For 6 weeks, patients will receive 6 sessions with active LiST probe, 2 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) frequency = 5Hz
The change of the pain domain of NIH-CPSI score from baseline to 12 weeks after final treatment.
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 change of the pain domain of NIH-CPSI score from baseline to 4 weeks after final treatment.
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 4 weeks after final treatment.
The change of total NIH-CPSI score (Q1-9)from baseline to 4 and 12 weeks after final treatment
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: baseline, 4 and 12 weeks after final treatment
The change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score from baseline to 4 and 12 weeks after final treatment
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: baseline, 4 and 12 weeks after final treatment
The change of quality of life domains (Q 7-9) of the NIH-CPSI score from baseline to 4 and 12 weeks after final treatment
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: baseline, 4 and 12 weeks after final treatment
The change of IIEF-ED score from baseline to 4 and 12 weeks after final treatment
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: baseline, 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domainsfrom baseline to 4 and 12 weeks after final
Time frame: baseline, 4 and 12 weeks after final treatment
No study locations are listed for this record.
Plan to share: No
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Institute for the Study of Urological Diseases, Greece