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Not yet recruiting NCT07066735

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

No phase Interventional Chronic Prostatitis (CP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ESWT, Phytotherapy that contains powder extract of (saw palmetto , tomato , uva ursi , pygeum and pumpkin.
Who it may be relevant to
Registry conditions: Chronic Prostatitis (CP). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • AinShams University hospitals — Cairo

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. PMID 23141933
  • 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
  • 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

Identifiers

NCT: NCT07066735 · FMASU RSS/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗