Benign Prostatic HyperplasiaProSeRePEANCT06181175
Treatment of BPH With CO2 Serenoa +PEA as Monotherapy or in Combination With Tamsulosin: ProSeRePEA Trial
A study testing PEAPROSTIL 600 + Tamsulosin 0.4 mg, Tamsulosin 0.4 mg and PEAPROSTIL 600 mg in people with Benign Prostatic Hyperplasia and Urinary Obstruction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia, Urinary Obstruction, Lower Urinary Tract Symptoms
- What is being tested?
- PEAPROSTIL 600 + Tamsulosin 0.4 mg, Tamsulosin 0.4 mg and PEAPROSTIL 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Michele Billia
Novara, 28100
Michele Billia, MD
About this study
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
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.
Read the 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.
- Being tested
- PEAPROSTIL 600 + Tamsulosin 0.4 mg, Tamsulosin 0.4 mg, PEAPROSTIL 600 mg
- Keywords
- BPH, benign prostatic hypertrophy
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAPROSTIL 600 + Tamsulosin 0.4 mgDrug
Also called PEAPROSTIL, Omnic
PEAPROSTIL 600 mg one sachet oral daily+ Tamsulosin 0.4 mg one tablet oral daily
Tamsulosin 0.4 mgDrug
Also called Omnic
Tamsulosin 0.4 mg one tablet oral daily
PEAPROSTIL 600 mgDrug
Also called PeaProstil
PEAPROSTIL 600 mg one sachet oral daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Tamsulosin 0.4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 1 year
Secondary outcomes (10)
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of Short Form Health Survey-36 questionnaires
comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of Short Form Health Survey-36 (36 questions) at 1,3,6 and 12 months
Measured: 1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of uroflowmetry with maximum urinary flow (ml/s)
comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of maximum urinary flow (ml/s) at 1,3,6 and 12 months
Measured: 1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of post voided volume (ml)
comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of post voided volume (ml) at 1,3,6 and 12 months
Measured: 1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of prostate volume (gr)
comparing patients receiving tamsulosin + peaprostil combination therapy (Arm 1) versus patients receiving tamsulosin monotherapy (Arm 3) in terms of prostate volume (gr) at 6 and 12 months
Measured: 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
comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (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)
Measured: 1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Quality of life
comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of Quality of life (QoL) (0-6 points) at 1,3,6 and 12 months (0 point good quality of life, 6 points bad quality of life)
Measured: 1 year
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
comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of Short Form Health Survey-36 (36 questions) at 1,3,6 and 12 months
Measured: 1 year
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)
comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of maximum urinary flow (ml/s) at 1,3,6 and 12 months
Measured: 1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of post voided volume (ml)
comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of post voided volume (ml) at 1,3,6 and 12 months
Measured: 1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of prostate volume (gr)
comparing patients receiving combination therapy group (Arm1) vs peaprostil group (Arm2) and peaprostil group (Arm2) vs tamsulosin alone (Arm 3) in terms of prostate volume (gr) at 6 and 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Oct 2021
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Billia, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Michele Billia, MD, Principal investigator, SCDU Urologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181175
- Sponsor's protocol ID
- ProSeRePEA trial, v.01
- Acronym
- ProSeRePEA
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06181175
- Acronym / sponsor ID
- ProSeRePEA / ProSeRePEA trial, v.01
- Keywords
- BPH, benign prostatic hypertrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM 1: PEAPROSTIL 600 mg + Tamsulosin 0.4 mg | Active comparator | Drug: PEAPROSTIL 600 + Tamsulosin 0.4 mgPEAPROSTIL 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. |
| ARM 2: PEAPROSTIL 600 mg | Active comparator | Drug: PEAPROSTIL 600 mgPEAPROSTIL 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. |
| ARM 3: Tamsulosin 0.4 mg | Active comparator | Drug: Tamsulosin 0.4 mgTamsulosin 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAPROSTIL 600 + Tamsulosin 0.4 mgAlso: PEAPROSTIL, OmnicPEAPROSTIL 600 mg one sachet oral daily+ Tamsulosin 0.4 mg one tablet oral daily | Drug | ARM 1: PEAPROSTIL 600 mg + Tamsulosin 0.4 mg |
| Tamsulosin 0.4 mgAlso: OmnicTamsulosin 0.4 mg one tablet oral daily | Drug | ARM 3: Tamsulosin 0.4 mg |
| PEAPROSTIL 600 mgAlso: PeaProstilPEAPROSTIL 600 mg one sachet oral daily | Drug | ARM 2: PEAPROSTIL 600 mg |
Primary outcome
Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire
Time frame: 1 year
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)
Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire
Time frame: 1 year
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)
10 secondary outcomes
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of Short Form Health Survey-36 questionnaires
Time frame: 1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of uroflowmetry with maximum urinary flow (ml/s)
Time frame: 1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of post voided volume (ml)
Time frame: 1 year
Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of prostate volume (gr)
Time frame: 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
Time frame: 1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Quality of life
Time frame: 1 year
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
Time frame: 1 year
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)
Time frame: 1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of post voided volume (ml)
Time frame: 1 year
Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of prostate volume (gr)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Billia, MD principal investigator
SCDU Urologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAPROSTIL 600 + Tamsulosin 0.4 mg, Tamsulosin 0.4 mg and PEAPROSTIL 600 mg in people with Benign Prostatic Hyperplasia and Urinary Obstruction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Billia, MD (+3903213733201, clinicaurologicanovara1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.