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

NCT ID: NCT07066735

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-20

Study Completion Date

2026-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Prostatitis (CP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A ESWT and Phytotherapy

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 Type EXPERIMENTAL

ESWT

Intervention Type 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

Intervention Type DRUG

1capsule tob be taken twice daily for one month.

Group B: ESWT alone

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 Type EXPERIMENTAL

ESWT

Intervention Type 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 3: Phytotherapy alone

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

1capsule tob be taken twice daily for one month.

Interventions

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ESWT

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)

Intervention Type DEVICE

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

1capsule tob be taken twice daily for one month.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Younan Ramsis

Lecturer of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Y. Yassin, Professor

Role: STUDY_CHAIR

Ain Shams University

Locations

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AinShams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Younan R. Samir, lecturer

Role: CONTACT

00201201255511

Walid E. Mousa, Assisstant Professor

Role: CONTACT

00201067628771

References

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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.

Reference Type BACKGROUND
PMID: 23141933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34635804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36544851 (View on PubMed)

Other Identifiers

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FMASU RSS/2025

Identifier Type: -

Identifier Source: org_study_id

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