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

NCT07066735 | Not Yet Recruiting DMC

• 1 other identifier: FMASU RSS/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Prostatitis (CP)

Keywords

Chronic prostatitis; ESWT; Phytotherapy; LUTS

Outcome Measures

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.

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

Study Arms (3)

Group A ESWT and Phytotherapy

EXPERIMENTAL

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.

Device: ESWT; Drug: Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin

Group B: ESWT alone

EXPERIMENTAL

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)

Device: ESWT

Group 3: Phytotherapy alone

ACTIVE COMPARATOR

Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum , pumpkin ) 1capsule twice daily

Drug: Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin

Interventions

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)

Group A ESWT and Phytotherapy; Group B: ESWT alone

Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin DRUG

1capsule tob be taken twice daily for one month.

Group 3: Phytotherapy alone; Group A ESWT and Phytotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams University hospitals

Cairo, Egypt

Location

Related Publications (3)

• Wagenlehner FM, van Till JW, Magri V, Perletti G, Houbiers JG, Weidner W, Nickel JC. National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) symptom evaluation in multinational cohorts of patients with chronic prostatitis/chronic pelvic pain syndrome. Eur Urol. 2013 May;63(5):953-9. doi: 10.1016/j.eururo.2012.10.042. Epub 2012 Nov 2.

  PMID: 23141933 BACKGROUND

• Sakr AM, Fawzi AM, Kamel M, Ali MM. Outcomes and clinical predictors of extracorporeal shock wave therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome: a prospective randomized double-blind placebo-controlled clinical trial. Prostate Cancer Prostatic Dis. 2022 Mar;25(1):93-99. doi: 10.1038/s41391-021-00464-8. Epub 2021 Oct 11.

  PMID: 34635804 BACKGROUND

• Palmieri A, Cai T, Di Luise L, D'Alterio C, La Cava G, Cirigliano L, Di Giovanni A, Gallelli L, Capece M. Extracorporeal shock wave therapy in association with bromelain and escin for the management of patients affected by chronic prostatitis/chronic pelvic pain syndrome. Biomed Rep. 2022 Nov 25;18(1):7. doi: 10.3892/br.2022.1589. eCollection 2023 Jan.

  PMID: 36544851 BACKGROUND

MeSH Terms

Interventions

saw palmetto extract; pygeum extract

Study Officials

• Mohammed Y. Yassin, Professor

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Younan R. Samir, lecturer

CONTACT

00201201255511; dr_yona@live.com

Walid E. Mousa, Assisstant Professor

CONTACT

00201067628771; waleedmousa2@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 15, 2025
• Study Start: July 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)