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

Not Applicable

Not yet recruiting

• Conditions: Chronic Prostatitis (CP)
• Interventions: Device: ESWT; Drug: Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin

• Registration Number: NCT07066735
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-06-28
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-17
• Study Start: 2025-07-20
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A ESWT and Phytotherapy	ESWT	First group will undergo ( ESWT -Transperineal- 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) (Zhang et al . 2018) combined with Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum , pumpkin ) 1capsule twice daily.
Group A ESWT and Phytotherapy	Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin	First group will undergo ( ESWT -Transperineal- 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) (Zhang et al . 2018) combined with Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum , pumpkin ) 1capsule twice daily.
Group B: ESWT alone	ESWT	Transperineal- 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)
Group 3: Phytotherapy alone	Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin	Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum , pumpkin ) 1capsule twice daily

Primary Outcome Measures

Name	Time	Method
compare the degree of symptoms relief between the three groups	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.

Trial Locations

Locations (1)

AinShams University hospitals; 🇪🇬 Cairo, Egypt