Clinical trial NCT06181175: Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Urinary Obstruction
Lower Urinary Tract Symptoms
Keywords: BPH
benign prostatic hypertrophy
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 250
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Study design

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.

Eligibility 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

Primary outcomes:
measure: Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire
timeFrame: 1 year
measure: Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of Short Form Health Survey-36 questionnaires
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of uroflowmetry with maximum urinary flow (ml/s)
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of post voided volume (ml)
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of prostate volume (gr)
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of International Prostate Symptoms Score
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Quality of life
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Short Form Health Survey-36 questionnaires
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of uroflowmetry with maximum urinary flow (ml/s)
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of post voided volume (ml)
timeFrame: 1 year
measure: Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of prostate volume (gr)
timeFrame: 1 year
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Michele Billia
Study officials:
affiliation: SCDU Urologia
name: Michele Billia, MD
role: PRINCIPAL_INVESTIGATOR
References: