Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial

NCT06181175 | Unknown

• 1 other identifier: ProSeRePEA trial, v.01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy of the supplement PEAPROSTIL 600 (FARMITALIA®) composed of Serenoa Repens combined with PEA in single or combined therapy with alpha-blocker in the reduction of voiding symptoms in benign prostatic hyperplasia (BPH) patients at low risk of progression to obstructing conditioning that need for surgical therapy. Any adverse events, intolerance, allergic reactions, complications related to the products used will be recorded throughout the study period.

Conditions

Benign Prostatic Hyperplasia; Urinary Obstruction; Lower Urinary Tract Symptoms

Keywords

BPH; benign prostatic hypertrophy

Outcome Measures

Primary Outcomes (2)

• Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire

  comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of International Prostate Symptoms Score (scale 0-35) at 1,3,6 and 12 months. (0 point no symptoms, 35 points many symptoms)

  1 year

• Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire

  comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of Quality of life (0-6 points) at 1,3,6 and 12 months (0 point good quality of life, 6 points bad quality of life)

  1 year

Secondary Outcomes (10)

• Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of Short Form Health Survey-36 questionnaires

  1 year

• Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of uroflowmetry with maximum urinary flow (ml/s)

  1 year

• Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of post voided volume (ml)

  1 year

• Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of prostate volume (gr)

  1 year

• Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of International Prostate Symptoms Score

  1 year

Study Arms (3)

ARM 1: PEAPROSTIL 600 mg + Tamsulosin 0.4 mg

ACTIVE COMPARATOR

PEAPROSTIL 600 is a food supplement based on Palmitoylethanolamide and Serenoa Repens, respectively for each sachet there are 600 mg of PEA and 320 mg of Serenoa oil. The net content of a sachet is 2.45 g and can be orodispersible without the need for the use of water. The drug does not contain gluten or lactose. • Tamsulosin 0.4 mg is a drug belonging to the category of alpha-blocker drugs used as first choice drugs (according to European Urology association guidelines) for the treatment of LUTS/BPH. The recommended dose is 0.4 mg per day (1 administration), to be taken preferably at the same time during the day, indifferently with or without meals.

Drug: PEAPROSTIL 600 + Tamsulosin 0.4 mg

ARM 2: PEAPROSTIL 600 mg

ACTIVE COMPARATOR

PEAPROSTIL 600 is a food supplement based on Palmitoylethanolamide and Serenoa Repens, respectively for each sachet there are 600 mg of PEA and 320 mg of Serenoa oil. The net content of a sachet is 2.45 g and can be orodispersible without the need for the use of water. The drug does not contain gluten or lactose.

Drug: PEAPROSTIL 600 mg

ARM 3: Tamsulosin 0.4 mg

ACTIVE COMPARATOR

Tamsulosin 0.4 mg is a drug belonging to the category of alpha-blocker drugs used as first choice drugs (according to European Urology association guidelines) for the treatment of benign prostatic hyperplasia. The recommended dose is 0.4 mg per day (1 administration), to be taken preferably at the same time during the day, indifferently with or without meals.

Drug: Tamsulosin 0.4 mg

Interventions

PEAPROSTIL 600 + Tamsulosin 0.4 mg DRUG

PEAPROSTIL 600 mg one sachet oral daily+ Tamsulosin 0.4 mg one tablet oral daily

Also known as: PEAPROSTIL, Omnic

ARM 1: PEAPROSTIL 600 mg + Tamsulosin 0.4 mg

Tamsulosin 0.4 mg DRUG

Tamsulosin 0.4 mg one tablet oral daily

Also known as: Omnic

ARM 3: Tamsulosin 0.4 mg

PEAPROSTIL 600 mg DRUG

PEAPROSTIL 600 mg one sachet oral daily

Also known as: PeaProstil

ARM 2: PEAPROSTIL 600 mg

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

Michele Billia

Novara, 28100, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Michele Billia, MD

  SCDU Urologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Billia, MD

CONTACT

+3903213733201; clinicaurologicanovara1@gmail.com

Volpe Alessandro, MD

CONTACT

+3903213733201; clinicaurologicanovara1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The statistical analysis is blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: December 26, 2023
• Study Start: October 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: April 30, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)