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NCT Number: NCT07066735

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

to compare the efficacy and safety of ESWT combined with phytotherapy, ESWT alone and phytotherapy alone in treatment of chronic prostatitis.

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Key information

Conditions

Chronic Prostatitis (CP)

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

AinShams University hospitals

Cairo, Egypt

About this study

In this study the investigators will conduct a Prospective randomized clinical trial, patients will be randomized to 3 groups where they will use use radial waves device (INTELECT RPW SHOCKWAVE) By Chattanooga for ESWT. Another group will receive Phytothyrapy that will be capsules containing powder extract of saw palmetto , tomato , uvaursi , pygeum and pumpkin. while the last group will receive both.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Perineal or pelvic pain or discomfort of at least 3 months
  • NIH-CPSI total score greater than 15,
  • Negative semen cultures for bacteria.

Exclusion criteria

  • Evidence of bacteria in seminal culture tests,
  • Urinary stones,
  • Uncontrolled coagulopathy,
  • Chronic bacterial prostatitis,
  • Bladder and prostate cancer,
  • Medications that could affect lower urinary tract function during the last month
  • Serum prostate-specific antigen levels (PSA) more than 4 ng/mL
  • History of prostate surgery or radiotherapy
  • Perineal anatomical abnormalities
  • Neurological abnormalities.
  • Previous extensive pelvic injuries

Treatment and study plan

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.

Primary outcomes

  1. compare the degree of symptoms relief between the three groups

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Walid E. Mousa, Assisstant Professor

CONTACT

[email protected]

00201067628771

Younan R. Samir, lecturer

CONTACT

[email protected]

00201201255511

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison of the Efficacy and Safety of Combined Extracorporeal Shock- Wave Therapy (ESWT) With Phytotherapy Versus Each of Them Alone in Chronic Prostatitis Category ⅢB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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