Chronic Prostatitis (CP)NCT07066735
Extracorporeal Shock-Wave Therapy (ESWT) vs Phytotherapy vs Combined in Treatment of Chronic Prostatitis
A study testing ESWT and Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin in people with Chronic Prostatitis (CP), run by Ain Shams University at 1 site in Egypt.
Trial summary
to compare the efficacy and safety of ESWT combined with phytotherapy, ESWT alone and phytotherapy alone in treatment of chronic prostatitis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Prostatitis (CP)
- What is being tested?
- ESWT and Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perineal or pelvic pain or discomfort of at least 3 months
- NIH-CPSI total score greater than 15,
- Negative semen cultures for bacteria.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
to compare the efficacy and safety of ESWT combined with phytotherapy, ESWT alone and phytotherapy alone in treatment of chronic prostatitis.
Read the 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.
- Conditions
- Chronic Prostatitis (CP)
- Being tested
- ESWT, Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin
- Keywords
- Chronic prostatitis, ESWT, Phytotherapy, LUTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTDevice
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 pumpkinDrug
1capsule tob be taken twice daily for one month.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Device: ESWT |
| Group 3: Phytotherapy alone | Active comparator | Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum , pumpkin ) 1capsule twice daily Receives: Drug: Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre intervenon, at 4 and 8 weeks post intervention and at 2 and 4 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis (CP)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younan Ramsis, Ain Shams University
- Investigators
- Mohammed Y. Yassin, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066735
- Sponsor's protocol ID
- FMASU RSS/2025
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23141933Sakr 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.
PubMed 34635804Palmieri 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.
PubMed 36544851
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07066735
- Acronym / sponsor ID
- FMASU RSS/2025
- Conditions
- Chronic Prostatitis (CP)
- Keywords
- Chronic prostatitis, ESWT, Phytotherapy, LUTS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A ESWT and Phytotherapy | Experimental | Device: ESWT, Drug: Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkinFirst 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 | Experimental | Device: ESWTTransperineal- 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 | Active comparator | Drug: Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkinPhytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum , pumpkin ) 1capsule twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Perineal or pelvic pain or discomfort of at least 3 months
- NIH-CPSI total score greater than 15,
- Negative semen cultures for bacteria.
Key exclusion criteria (11 listed)
- Evidence of bacteria in seminal culture tests,
- Urinary stones,
- Uncontrolled coagulopathy,
- Chronic bacterial prostatitis,
- Bladder and prostate cancer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESWTTransperineal 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) | Device | Group A ESWT and Phytotherapy, Group B: ESWT alone |
| Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin1capsule tob be taken twice daily for one month. | Drug | Group 3: Phytotherapy alone, Group A ESWT and Phytotherapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 23141933Wagenlehner 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.
- Background: PubMed 34635804Sakr 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.
- Background: PubMed 36544851Palmieri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Y. Yassin, Professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT and Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin in people with Chronic Prostatitis (CP), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Younan R. Samir, lecturer (00201201255511, dr_yona@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07066735, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.