Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial
NCT ID: NCT06181175
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2021-10-01
2025-04-30
Brief Summary
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Detailed Description
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Single-center 3-arm randomized prospective clinical trial.
* Arm 1: PEAPROSTIL 600 + Tamsulosin 0.4 mg
* Arm 2: PEAPROSTIL 600
* Arm 3: Tamsulosin 0.4 mg
At the time of study enrollment, each patient will be randomized into one of the 3 arms described. Randomisation will take place with a 1: 1: 1 scheme.
All the variables will be collected by a medical co-investigator of Prof. Alessandro Volpe's team during the follow-up visits at pre-established intervals of 1, 3, 6 and 12 months (respectively T1, T2, T3 and T4) and will be reported in the special data collection folder (CRF).
At 1 month (T1) 3 months (T2), 6 months (T3) and 12 months (T4):
Personal data: identification number and initials of the patient's name and surname, date of birth, telephone number and e-mail address History: International Prostate Symptoms Score questionnaire, Short Form Health Survey-36 questionnaires Physical examination: abdominal, urological including rectal examination Uroflowmetry: analysis of the morphology of the flow curve, Qmax, volume of urine emptied, post-voiding residue).
250 patients will be recruited. The sample analysis was performed by the Department of Medical, Surgical and Advanced Technologies "Ingrassia" of the University of Catania for a study power of 90% and an Alpha error of 0.05 (statistical significance). In particular, the design involves a 3-arm randomization process 1: 1: 1. Expecting a difference of at least 2 points in the International Prostate Symptoms Score questionnaire and Qmax and a standard deviation of 4. It is necessary to enroll 250 patients to obtain a statistic of 90% at a significance level of 0.05. The statistical analysis of the data collected during the study, according to an intention-to-treat procedure, will be performed using statistical software including IBM SPSS statistics version 23.0. A descriptive analysis of the patients included in the three arms will be performed using the appropriate frequency measurements and central tendency and dispersion indices. Considering a pair of the three arms at a time (1 vs. 2; 1 vs. 3; 2 vs. 3), the qualitative variables will be compared using the chi-squared test; quantitative variables will be compared by Student's t-test. The significance level will be set at p \<0.05. For the variables that will be significant in the univariate analysis, multivariate analyzes will be carried out using appropriate regression models.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ARM 1: PEAPROSTIL 600 mg + Tamsulosin 0.4 mg
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.
PEAPROSTIL 600 + Tamsulosin 0.4 mg
PEAPROSTIL 600 mg one sachet oral daily+ Tamsulosin 0.4 mg one tablet oral daily
ARM 2: PEAPROSTIL 600 mg
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.
PEAPROSTIL 600 mg
PEAPROSTIL 600 mg one sachet oral daily
ARM 3: Tamsulosin 0.4 mg
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.
Tamsulosin 0.4 mg
Tamsulosin 0.4 mg one tablet oral daily
Interventions
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PEAPROSTIL 600 + Tamsulosin 0.4 mg
PEAPROSTIL 600 mg one sachet oral daily+ Tamsulosin 0.4 mg one tablet oral daily
Tamsulosin 0.4 mg
Tamsulosin 0.4 mg one tablet oral daily
PEAPROSTIL 600 mg
PEAPROSTIL 600 mg one sachet oral daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
MALE
Yes
Sponsors
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Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
Responsible Party
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Michele Billia
Medical doctor
Principal Investigators
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Michele Billia, MD
Role: PRINCIPAL_INVESTIGATOR
SCDU Urologia
Locations
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Michele Billia
Novara, , Italy
Countries
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Central Contacts
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Facility Contacts
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Michele Billia, MD
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ProSeRePEA trial, v.01
Identifier Type: -
Identifier Source: org_study_id