Extracorporeal Shock-Wave Therapy (ESWT) vs Phytotherapy vs Combined in Treatment of Chronic Prostatitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorAin Shams University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ESWT

    Device

    Transperineal 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

    Drug

    1capsule tob be taken twice daily for one month.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group A ESWT and PhytotherapyExperimental treatment 2 interventions
Group B: Group B: ESWT aloneExperimental treatment 1 intervention
Group C: Group 3: Phytotherapy aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
pre intervenon, at 4 and 8 weeks post intervention and at 2 and 4 months post intervention.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: