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

July 14, 2025 updated by: Younan Ramsis, Ain Shams University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Younan R. Samir, lecturer
  • Phone Number: 00201201255511
  • Email: dr_yona@live.com

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ainshams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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)
Drug: Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin
1capsule tob be taken twice daily for one month.
Experimental: 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)
Device: 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)
Active Comparator: Group 3: Phytotherapy alone
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
1capsule tob be taken twice daily for one month.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
pre intervenon, at 4 and 8 weeks post intervention and at 2 and 4 months post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mohammed Y. Yassin, Professor, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU RSS/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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