About this trial
to compare the efficacy and safety of ESWT combined with phytotherapy, ESWT alone and phytotherapy alone in treatment of chronic prostatitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Perineal or pelvic pain or discomfort of at least 3 months
NIH-CPSI total score greater than 15,
Negative semen cultures for bacteria.
Disqualifiers
Evidence of bacteria in seminal culture tests,
Urinary stones,
Uncontrolled coagulopathy,
Chronic bacterial prostatitis,
Trial design
Parallel
Treatments tested in this trial
ESWT
DeviceTransperineal Shockwaves that are applied once a week for 8 consecutive weeks with a protocol of 3000 pulses each; pressure: 1.8-2.0 bar and a frequency of 10 Hertz (Hz)
Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin
Drug1capsule tob be taken twice daily for one month.
Treatment groups
Trial outcomes
Primary outcomes
compare the degree of symptoms relief between the three groups
using National Institutes of Health-developed Chronic Prostatitis Symptom Index (NIHCPSI) that will be filled by the patients pre and post intervention at 4 weeks and 8 weeks, 2 and 4 months. It comprises three key domains: pain (scored from 0 to 21), urinary symptoms (0 to 10), and the impact on quality of life (0 to 12), with a total score range spanning from 0 to 43. Higher scores reflect more severe symptoms and a worse overall outcome, while lower scores indicate milder symptoms and a better clinical picture. Severity is typically interpreted as mild (0-9), moderate (10-18), severe (19-31), and very severe (32-43), making the scale valuable for both diagnosis and monitoring treatment progress.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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