Benign Prostatic Hyperplasia Clinical Trial
— ProSeRePEAOfficial 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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | April 30, 2025 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Michele Billia | Novara |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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) |
1 year | |
Secondary | 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) | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year |
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