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
Phase: NA
Conditions: Benign Prostatic Hyperplasia, Urinary Obstruction, Lower Urinary Tract Symptoms
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

                                                                            
S.C.D.U. Urology
Director Prof. Alessandro Volpe
Novara, 02/17/2021
                                                                                    
TITLE OF THE STUDY: Evaluation of the efficacy of the treatment of benign prostatic 
hypertrophy with Serenoa Repens extracted with CO2 + PEA (Palmitoylethanolamide) in 
monotherapy or in combination with tamsulosin. ProSeRePEA trial.
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1. Introduction and rationale
Lower urinary tract symptoms (LUTS) can be divided into filling, micturition and post-void 
symptoms [1]. LUTS include: diurnal and nocturnal pollakiuria, urinary urgency, incontinence, 
hypovalid voiding, voiding hesitation, prolonged urination time, voiding dribbling and paradoxical 
iscuria.  LUTS  cause  disturbance  and  compromise  quality  of  life  [2-5].  Lower  urinary  tract 
symptoms are strongly associated with aging [2, 3], so costs and patient numbers are likely to 
increase with future demographic changes [3, 7].
Most older men have at least one symptom [3], however, symptoms are often mild and tolerable [5, 
6, 8]. The progression of this symptomatology in each individual is very subjective, in some 
patients the symptoms are worsening and dynamic, for others they remain more stable over time 
[3].
LUTS are mainly related to bladder outlet obstruction from benign prostatic hypertrophy (BPH). [1, 
4]. However, they can also be related to bladder and urinary tract abnormalities, such as anatomical 
or functional abnormalities (detrusor hyperreactivity, urinary infections, neoplasms, lithiasis) [3, 9]. 
Prostatic hypertrophy is due to hyperplasia of both the epithelial and stromal components and 
originates in the periurethral region of the gland. In the initial stages, there is a development of 
micronodules of stromal and glandular tissue in the periurethral area; over the years these nodules 
increase in size by compressing and distorting the prostatic urethra, hindering the urinary flow. 
Hormonal, immune, dietary, neurological and genetic factors are involved in the genesis of BPH. 
An alteration of the balance at a local level between estrogens and androgens is recognized. This 
phenomenon increases the ability to capture testosterone which stimulates cell growth and therefore 
prostatic hyperplasia. Glandular growth, i.e. of the adenoma, causes both urethral compression and 
peripheral  compression  of  the  remaining  part  of  the  parenchyma.  This  situation  causes  an 
intraglandular inflammatory picture which results in asymptomatic abacterial chronic prostatitis 
which can be found at the histological level of patients undergoing endoscopic resection of prostate 
adenoma. This inflammation aggravates and worsens the underlying urinary symptoms. According 
to European guidelines (UAE), the diagnosis of BPH must make use of a complete anamnestic 
collection to know any comorbidities of the patient. It must make use of the use of questionnaires to 
be submitted to each patient (e.g. IPSS, International Prostate Symptom Score), with the aim of 
quantifying voiding symptoms and monitoring worsening/improvements over time after medical 
therapy [10]. The patient should maintain a voiding diary to evaluate micturition characteristics, 
including voided volume in 24 hours, voiding frequency, and fluid intake. It is important for the 
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doctor to perform an objective examination of the patient, abdominal and genital, including rectal 
exploration  to  evaluate  the  prostate  volume,  consistency,  any  irregularities  and  tenderness. 
Urinalysis with urine culture should be included in the primary evaluation of any patient with LUTS 
to identify conditions such as urinary tract infections (UTIs), microhematuria, and diabetes mellitus.
It is important to determine the PSA (prostate specific antigen), a protease produced exclusively by 
prostatic epithelial cells, as it has a good positive predictive value since it increases in the course of 
both benign and malignant prostate diseases. In fact, it increases with the increase in the volume of 
the  gland,  increases  in  the  course  of  inflammatory  processes  and  in  the  course  of  prostate 
adenocarcinoma. Second level tests will have to be performed to make a correct differential 
diagnosis between these pathologies having a different therapeutic approach. The normal reference 
PSA value is <4 ng/ml and can be associated with its ratio (ratio between free PSA and total PSA, 
the higher it is, the more likely it is to be a benign disease).
Kidney function can be assessed by serum creatinine and estimated glomerular filtration rate 
(eGFR). Hydronephrosis, renal insufficiency or urinary retention are more frequent in patients 
suffering from BPH. One study reported that 11% of men with LUTS had renal insufficiency [11].
Uroflowmetry is a non-invasive urodynamic (time-volume) test widely used and recommended by 
guidelines for the initial diagnosis of LUTS. The parameters to consider are: Qmax, voided urine 
volume and flow morphology. These parameters, to be considered optimal, must be obtained when 
the volume of urine emptied remains between 150 and 400 ml. The morphology of the flow is "bell" 
shaped with a Qmax > 15 ml/s as a rule. A curve with a flattened and lengthened morphology over 
time is pathological.
Uroflowmetry is limited as a diagnostic test because it cannot provide a diagnosis of the underlying 
disease but can be used for monitoring treatment outcomes and for correlating symptoms with 
objective findings [12].
With regards to imaging, renovesical ultrasound is recommended if, in addition to the LUTS 
mentioned above, there is hematuria or a history of kidney stones. Prostate ultrasound can be 
performed suprapubically or transrectally; it is essential to perform if surgery for BPH is planned, as 
the calculation of the prostate volume can decide which therapeutic procedure to perform [13]. The 
prostatic volume calculated by the suprapubic approach appears to be overestimated compared to 
that by the transrectal approach. Diagnostic cystoscopy is not recommended in patients with BPH.
Treatment of obstructive prostatic hypertrophy can be classified into three types:
- watchful waiting
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-Pharmacological treatment
-surgical treatment
The choice of therapy is based on the severity/severity of symptoms estimated by the IPSS 
questionnaire.
In the presence of an IPSS score < 8, watchful waiting is possible (pharmacological therapy is not 
indicated). When the IPSS score > 8, it is indicated to start pharmacological therapy according to 
international guidelines. Surgery is confined to patients who do not respond to drug therapy and/or 
develop complications of an obstructive nature: obstructive renal failure, bladder stones with 
recurrent urinary tract infections, recurrent macroscopic haematuria.
Pharmacological treatment of prostatic hypertrophy mainly consists of alpha-blocker drugs, 5 alpha 
reductase inhibitors and herbal medicines.
α1-blockers (e.g. tamsulosin, alfluzosin) aim to inhibit the effect of norepinephrine released on the 
smooth muscle cells of the prostate and thus aim to reduce the tone of the prostate and bladder neck 
[14]. These drugs also act on other receptors in other parts of the body, such as blood vessels, 
resulting in adverse effects, such as hypotension.
The different α1-blockers available on the market have similar efficacy in appropriate doses [16]. 
The effects take a couple of weeks to develop completely burned, but significant efficacy versus 
placebo can occur within hours or days [15].
Controlled studies show that α1-blockers typically reduce IPSS by approximately 30-40% and 
increase Qmax by approximately 20-25% [17]. α1-blockers do not reduce prostate size [18]. The 
most frequent adverse events of α1-blockers are asthenia, dizziness and orthostatic hypotension. 
They do not negatively affect libido, have a small beneficial effect on erectile function, but 
sometimes cause abnormal ejaculation [19]. Originally, abnormal ejaculation was associated with 
retrograde ejaculation, but more recent data show that it is due to a decrease or absence of seminal 
fluid during ejaculation.
Thus, α1-blockers are often considered the first-line pharmacological treatment of LUTS due to 
their rapid action, good efficacy, low frequency and severity of adverse events. However, α1-
blockers do not prevent the onset of acute urinary retention and the need for surgery for BPH.
Another category of drugs involved in the treatment of BPH are the 5 alpha reductase inhibitors (5-
ARIs). The effects of androgens on the prostate are mediated by dihydrotestosterone (DHT), which 
is converted from testosterone by the enzyme 5α-reductase. There are two isoforms of this enzyme:
• 5α-reductase type 1, activity predominant in extraprostatic tissues, such as skin and liver.
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• 5α-reductase type 2, predominant in the prostate.
Two 5-ARIs are available for clinical use: dutasteride and finasteride. Finasteride inhibits type 2 5α-
reductase only, whereas dutasteride inhibits type 1 and type 2 5α-reductase with similar potency. 
5α-reductase inhibitors work by inducing apoptosis of prostate epithelial cells [20] leading to a 
reduction in prostate size by approximately 18-28% and a decrease in circulating PSA levels by 
approximately 50% after six to twelve months of treatment [21].
Placebo-related clinical effects are observed after a minimum treatment duration of at least six to 
twelve months. An indirect comparison and a direct comparative trial (twelve months duration) 
indicate that dutasteride and finasteride are equally effective in the treatment of LUTS [21, 23]. The 
greater the baseline prostate volume, the greater the symptomatic benefit of dutasteride over 
tamsulosin.
5α-reductase inhibitors, but not α1-blockers, reduce the long-term risk (> 1 year) of acute urinary 
retention or the need for surgery [22, 24].
The most notable adverse effects of 5-ARIs are related to sexual function and include decreased 
libido, erectile dysfunction (ED), and less frequently, ejaculation disorders such as retrograde 
ejaculation, ejaculation failure, or decreased semen volume [ 21]. Gynecomastia develops in 1-2% 
of patients.
According to guidelines (EAU), in addition to the two categories of drugs mentioned above, there 
are also treatments for BPH based on natural extracts (phytotherapy).
Herbal medicines  are made  from roots, seeds, pollen,  bark or fruit.  There are single herbal 
preparations and preparations that combine two or more plants in one tablet. The most used plants 
are Cucurbita pepo (pumpkin seeds), Hypoxis rooperi (South African star grass), Pygeum africanum 
(African plum tree bark), Secale cereale (rye pollen), Serenoa repens (dwarf palm) and Urtica dioica 
(roots  of  'nettle).  In  vitro,  plant  extracts  may  have  anti-inflammatory,  anti-androgenic  and 
estrogenic effects; they can inhibit aromatase, lipoxygenase, growth factor-stimulated proliferation 
of prostate cells, α-adrenoreceptors, 5α-reductase, muscarinic cholinoceptors, dihydropyridine and 
vanilloid  receptors,  and neutralize  free  radicals  [25-26]. Pharmacokinetic  properties  can  vary 
significantly depending on how Serenoa repens is extracted.
Herbal therapeutic agents are a heterogeneous group and may contain different concentrations of 
active ingredients. In general, no herbal agent has been shown to reduce prostate size and a decrease 
in the progression of BPH has not been demonstrated [27-28]. Side effects during herbal medicine 
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are usually mild and comparable to placebo. Gastrointestinal disturbances are the most common 
reported.
Short-term studies have recently been performed on the combination of plant extracts with alpha-
blockers and 5-ARIs.
PROCOMB study (2014): randomized double-blind multicenter study for 12 months of treatment in 
which  patients  were divided into 3 groups; group A, who received  only Serenoa Repens  + 
Lycopene (Ly) + Selenium (Se); group B, who received only tamsulosin 0.4 mg; group C, who 
received tamsulosin 0.4 mg + SerR + Ly+Se. The aim of the study was to achieve an improvement 
in some parameters (IPSS, post-void residual and Qmax at uroflowmetry) in patients in group C 
compared to those in group B. The results demonstrated a better efficacy of the combined therapy 
of group C compared to the single therapy of group B, (increase in Qmax and decrease in IPSS 
value). [29]
QUALIPROST study (2015): prospective, longitudinal, observational and multicenter study with 
the evaluation of 6 months of treatment. We included patients not taking any therapy, patients on 
monotherapy (with alpha-blockers, 5-ARIs and Serenoa Repens hexane extract) and patients on 
combined therapy (alpha-blockers + 5-ARIs and alpha-blockers + Serenoa Repens) .
The results obtained demonstrated comparable efficacy in the use of combined therapy with alpha 
blocker + Serenoa repens and with alpha blocker + 5-ARI [30].
To date, there are no scientific studies in the literature that evaluate the efficacy of the treatment of 
BPH with Serenoa Repens extracted with CO2 and PEA (palmitoylethanolamide) (PEAPROSTIL 
600, FARMITALIA®). PEA is a substance produced by all living beings with analgesic and anti-
inflammatory properties. It protects cells and tissues from oxidative damage, reduces chronic pain 
and restores the physiological tissue balance. It was discovered in 1957 and studied by Rita Levi di 
Montalcini, who won the Nobel prize in 1993. This synergistic action deriving from the combined 
activity of Serenoa Repens and PEA can lead to a reduction of the chronic prostatic inflammatory 
process (chronic abacterial prostatitis) in patients with BPH. PEAPROSTIL 600 (FARMITALIA®) 
is a supplement that is administered in orodispersible form without the need for the use of water and 
each sachet is 2.45 gr.
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2. Objectives of the study
The objective of this study is to evaluate the efficacy of the PEAPROSTIL 600 (FARMITALIA®) 
supplement composed of Serenoa Repens associated with PEA combined with alpha-blocker in the 
reduction of LUTS symptoms in patients with IBP. During the entire study period, any adverse 
events, intolerance, allergic reactions, complications related to the products used will be recorded.
2.1 Primary Outcomes:
1) Evaluate the efficacy of the treatment in terms of subjective improvement of urinary symptoms 
by performing IPPS and SF-36 questionnaires and evaluate the objective improvement of urinary 
symptoms by performing uroflowmetry before and during treatment (during control visits follow-up 
at 1,3,6 and 12 months) by evaluation of the ultrasound post-voiding residue, comparing patients 
receiving  combined  therapy  with  tamsulosin+peaprostil  (Arm  1)  with  patients  receiving 
monotherapy with tamsulosin (Arm 3).
2.2 Secondary Outcomes:
1). Evaluate the tolerability profile of the study therapy, analyzing the side effects.
2). Evaluate the efficacy of the treatment in terms of subjective improvement of urinary symptoms 
by performing IPPS and SF-36 questionnaires and evaluate the objective improvement of urinary 
symptoms by performing uroflowmetry before and during treatment (during follow-up visits -up at 
1,3,6 and 12 months) by means of ultrasound evaluation of the post-voiding residue, comparing the 
patients of the 3 study groups (Arm 1, 2 and 3).
3. Study design
The study is a single-center, 3-arm, prospective randomized clinical trial.
• Arm 1: PEAPROSTIL 600 + Tamsulosin 0.4 mg/dl
• Arm2: PEAPROSTIL 600
• Arm 3: Tamsulosin 0.4 mg
Upon enrollment in the study, each patient will be randomized into one of the 3 arms described. 
Randomization will take place in a 1:1:1 pattern.
Based on clinical-scientific considerations inherent to the typology of patients and to reality
clinic, the experimental design indicated above currently corresponds to the best possible.
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3.1 Composition of the therapy
• 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 EAU lines) 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.
4. Patient selection
4.1 Target population
Patients referred to outpatient visits eligible for study at the S.C.D.U. of Urology of the Maggiore 
Hospital of Charity of Novara.
4.2 Inclusion criteria
o Male patients aged 40 years or older
o Patients with baseline IPSS questionnaire between 8 and 14
o Patients with prostate volume ≤ 60 cc assessed by transrectal ultrasound (TRUS)
o Patients who have a Qmax ≤ 15 ml/sec on uroflowmetry
o Patients who show a post-voiding residue ≤ 120 ml on extemporaneous ultrasound
o Patients who have signed the informed consent for participation in the study
o Patients able to understand the conditions of the study and to participate for the full duration.
4.3 Exclusion Criteria
o Patients suffering from urinary incontinence
o Patients with overactive bladder
o Patients with neurological bladder
o Patients with active malignancies and who have been treated for malignancy in the previous 6 
months
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o Patients suffering from local or systemic infections (UTI, osteomyelitis, sepsis, etc.)
o Patients with renal insufficiency
o Patients with bladder stones
o Patients with gross haematuria
5. Study procedure
5.1 Data Collection Method
Each patient participating in the study will be uniquely identified by an alphanumeric code. All the 
data required by the protocol, relating to the patient, to the medical record, to the therapeutic 
intervention, to the checks following discharge from the hospital, will be recorded by a co-
investigator who will directly follow the study and its correct conduct for its entire duration. 
duration. All data will initially be recorded on forms in paper format which will form the data 
collection folder (CRF).
A file containing all completed forms and signed informed consent will be kept for each patient.
Information concerning patients (identification codes, personal data, medical records, consent, 
information privacy policy) will be kept by the Investigator in special confidential archives (patients 
file) to guarantee the privacy of the subjects and exhibited in the event of audits, inspections or 
monitoring visits. All the variables under study will be entered in a dedicated and password-
protected database, kept at S.C.D.U. Urology, The database will be shared on a cloud-protected 
server with the Biostatistics department of the University of Catania which will carry out the 
statistical analysis (Prof. Martina Barchitta). The Investigator and co-Investigators will be the only 
ones to have access to the database.
5.1.1 Method of randomization
Randomization will take place in a 1:1:1 pattern. Based on considerations
clinical-scientific inherent to the typology of patients and to the clinical reality, the design
experimental above currently corresponds to the best possible.
5.2 Pre-treatment assessment
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All patients will undergo an accurate analysis of the following parameters (T0).
- Personal data: identification number and initials of the patient's name and surname, date of birth, 
telephone number and e-mail address.
- General characteristics: gender, weight, height, smoker, coffee and/or tea intake, allergies, job, 
sport, diabetes mellitus.
- Medical therapy in progress.
- Remote pathological history: previous surgical interventions, underlying pathologies and number 
of deliveries.
- Past pathological history and diagnosis: starting date and type of symptomatology
- Assessment of quality of life (QoL questionnaire).
- Voiding assessment (IPSS questionnaire)
- Physical examination: abdominal, urological including rectal examination.
- Uroflowmetry (morphology of the curve, Qmax, Vol, RPM-residual evaluation
post urination)
5.3 Measurements during the treatment cycle
All data collected during the administration of the therapy will be collected and reported in the 
appropriate  data collection  folder (CRF) by a co-investigator  doctor  from the team  of Prof. 
Alessandro Volpe.
5.3.1 Safety assessment and appearance of adverse events:
An adverse event is considered any unfavorable and unwanted sign, symptom or disease found in a 
patient participating in a clinical study temporarily associated with the use of an experimental 
product, even if it does not necessarily have a causal relationship with the treatment received. 
Clinical and/or pathological conditions present prior to initiation of study treatment are considered 
adverse events only if they worsen after initiation of study treatment.
Every adverse event that occurred during the execution of the study will be recorded.
In  the  event  of  an  adverse  event,  the  Investigator  will  promptly  institute  the  appropriate 
investigations and therapeutic measures. Any adverse event occurring during the study should be 
treated according to recognized treatment standards. If necessary, the patient will be withdrawn 
from the study.
The procedures foreseen by the study do not involve any additional risk for the patient's health.
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The Investigator must promptly report, within 24 hours, any adverse event that occurs to patients 
during the study to the Ethics Committee, to the Promoter, in accordance with the provisions of the 
law.
In the event of accidents (defined by article 9, paragraph 1 of Legislative Decree 46/97 and by 
article 11, paragraph 1 of Legislative Decree 507/92) that may have occurred during the project, the 
reports will be sent to the Office V (Medical Device Supervision) of the DGDFSC (General 
Directorate of Medical Devices, Pharmaceutical Service and Care Safety) of the Ministry of Health, 
according to the procedures set out in Meddev 2.12-1 rev 6 year 2009, by the Promoter. The 
information relating to the accidents will also be sent to the Manufacturer.
5.3.2 Expected Adverse Events
Predicted adverse events include all those events that are expected to occur in association with any 
routine treatment. No serious adverse events have ever been reported in the literature regarding the 
use of tamsulosin.
Common effects (<1/10 cases, > 1 100 cases (1-10%)): dizziness, particularly on sitting or standing 
up. Abnormal ejaculation (ejaculation disorder). This symptom means that the seminal fluid does 
not leave the body through the urethra but enters the urinary bladder (retrograde ejaculation) or that 
the volume of seminal fluid is reduced or absent (ejaculation failure). Uncommon effects (>1/1000 
cases, <1/100 cases (0.1-1%)): headache, palpitations (heart beats more frequently than normal and 
is also noticeable), decrease in blood pressure to example rising quickly from sitting or lying down 
often associated with dizziness, stuffy or runny nose (rhinitis), diarrhoea, nausea and vomiting, 
constipation, weakness (asthenia), rash, itching and hives.
Rare effects ((>1/10000 cases, <1/1000 cases (0.01-0.1%)): fainting and cases of sudden localized 
swelling of soft tissues of the body (e.g. of the throat and tongue), difficulty breathing and/or 
itching and rash (rash), as frequently in an allergic reaction (angioedema).
Very rare effects (<1/10,000 cases (<0.01%)): priapism (painful and prolonged involuntary erection 
requiring immediate medical treatment).
The  most  frequent  adverse  events  from  the  use of  tamsulosin  were  orthostatic  hypotension, 
retrograde ejaculation and ejaculation failure, gastrointestinal disorders [31].
5.3.3 Adverse event reporting period
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The adverse event baseline period for this study begins on day 0 and ends 30 days after study 
completion. All adverse events should be documented in the data collection record (CRF), as well 
as any other events considered potentially related to the device.
5.4 Post-treatment evaluation protocol
All the variables will be collected by a co-investigator of Prof. Alessandro Volpe's team during 
check-ups at pre-established intervals of 1, 3, 6 and 12 months (T1, T2, T3 and T4 respectively) and 
will be reported in the specific 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
- Medical history: IPSS, SF-36
- Physical examination: abdominal, urological including rectal examination
- Uroflowmetry: morphological analysis of the flow curve, Qmax, Volume of urine emptied, RPM).
6. Sample size and statistical analysis of the data
A total of 250 patients will be recruited. The sample analysis was performed by the “GF Ingrassia” 
Department  of  Medical,  Surgical  Sciences  and  Advanced  Technologies  of  the  University  of 
Catania. In particular, the design foresees a 1:1:1 randomization process in 3 arms. Expect a 
difference of at least 2 points in IPSS and Qmax and a standard deviation of 4, as described in 
previous studies (Morgia et al., 2014; Alcaraz et al., 2016), it is necessary to enroll 250 patients to 
obtain a power 90% statistic 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 such as IBM SPSS statistics version 23.0. 
The variables that will be collected in order to evaluate the efficacy of the therapy will be: 
chronological age, weight, BMI, smoking, diabetes, PSA, IPSS, Postvoiding Residual, Qmax, 
QMed, Voided volume, SF-36 score. A descriptive analysis of the patients included in the three 
arms will be performed using the appropriate frequency measures and indices of central tendency 
and dispersion. Considering one 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; the quantitative variables will be 
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compared using Student's t-test. The level of significance will be set at p < 0.05. For the variables 
that will be significant in the univariate analysis, multivariate analyzes will be performed using 
appropriate regression models to control for the effect of the covariates.
7. Duration of the study
The duration of the study will be 1 year. The enrollment of patients will take place for 1 year, the 
follow-up will be concluded 1 year after enrollment. A preliminary statistical analysis will be 
performed with the data obtained at 3 and 6 months. The final analysis will be conducted upon 
completion of the study.
8. Publication Policy
The results of this study will be summarized and presented in a final report which will have the aim 
of drawing reliable conclusions regarding the effective efficacy of using PEAPROSTIL 600 in the 
treatment of benign prostatic hypertrophy. The scientific article will then be sent to a peer-reviewed 
journal in the sector to be published in order to disseminate the results obtained to the scientific 
community. The data produced in this survey will be owned by the Ospedale Maggiore della Carità, 
Corso Mazzini 18, 28100, Novara, Italy.
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9. Bibliography
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2. Martin, S.A., et al. Prevalence and factors associated with uncomplicated storage and voiding 
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10. Abbreviations index
LUTS: low urinary tract symptoms
BPH: benign prostatic hypertrophy
PSA: prostate specific antigen
IPSS: International Prostatic Symptoms Score
QoL: quality of life questionnaire
CO2: Carbon dioxide
PEA: Palmitoylethanolamide
Qmax: maximum flow
5-ARI: 5α-reductase inhibitors
DE: erectile dysfunction
RPM: post-voiding residue
Vol: volume
Cr: creatininemia
eGFR: glomerular filtration rate
UTI: urinary tract infection
CRF: data collection folder
TRUS: transrectal ultrasound
DHT: dihydrotestosterone
Echo: ultrasound
s: seconds
ml: millilitres
ng: nanograms
T0: zero time
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T1: 1 month
T2: 3 months
T3: 6 months
T4: 12 months
Novara, 17/02/2021 Dr. Michele Billia
Pag. 19 di 19