Treatment for benign prostatic hyperplasia using a supplement and medication
Valutazione Dell'Efficacia Del Trattamento Dell'Ipertrofia Prostatica Benigna Con Serenoa Repens Estratta Con CO2 + PEA (Palmitoilethanolamide) in Monoterapia o in Combinazione Alla Tamsulosina: ProSeRePEA Trial
This study is testing whether a new supplement combined with a common medication can help men over 40 with benign prostatic hyperplasia feel better by reducing their bathroom symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara) |
| Trial ID | NCT06181175 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of PEAPROSTIL 600, a supplement made from Serenoa Repens combined with PEA, either alone or in combination with Tamsulosin, for reducing voiding symptoms in men with benign prostatic hyperplasia (BPH). The study is a single-center, three-arm randomized trial involving 250 male participants aged over 40, who will be monitored over 12 months for symptom improvement and any adverse effects. Participants will be randomly assigned to one of three treatment groups: PEAPROSTIL 600 with Tamsulosin, PEAPROSTIL 600 alone, or Tamsulosin alone.
Who should consider this trial
Good fit: Ideal candidates are men over 40 with mild to moderate BPH symptoms and specific urinary flow metrics.
Not a fit: Patients with urinary incontinence, overactive bladder, or other significant urinary tract issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for men suffering from BPH, improving their urinary symptoms and quality of life.
How similar studies have performed: Other studies have shown promise in using similar supplements for BPH, but this specific combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male with age\> 40 years * baseline International Prostate Symptoms Score between 8 and 14 * prostate volume ≤ 60 cc assessed by transrectal ultrasound (TRUS) * maximum flow (Qmax at uroflowmetry) ≤ 15 ml / sec * post voiding residue on extemporaneous ultrasound ≤ 120 ml * Signature of informed consent for participation in the study * ability to understand the conditions of the study and to participate in the study throughout its duration. Exclusion Criteria: * urinary incontinence * overactive bladder * neurological bladder * malignancies in progress and which have undergone treatment in the previous 6 months * local or systemic infections (urinary tract infection, osteomyelitis, sepsis, etc.) * kidney failure * macrohematuria * bladder stones
Where this trial is running
Novara
- Michele Billia — Novara, Italy (Recruiting)
Study contacts
- Principal investigator: Michele Billia, MD — SCDU Urologia
- Study coordinator: Michele Billia, MD
- Email: clinicaurologicanovara1@gmail.com
- Phone: +3903213733201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.