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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The statistical analysis is blind
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PEAPROSTIL 600 + Tamsulosin 0.4 mg (Drug)
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.
干预措施: PEAPROSTIL 600 mg (Drug)
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.
干预措施: Tamsulosin 0.4 mg (Drug)
结局指标
主要结局
Efficacy of treatment of combination therapy group vs tamsulosin group in Quality of Life questionnaire
时间窗: 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)
Efficacy of treatment of combination therapy group vs tamsulosin group in International Prostate Symptoms Score questionnaire
时间窗: 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)
次要结局
- Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of Short Form Health Survey-36 questionnaires(1 year)
- Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of prostate volume (gr)(1 year)
- Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of uroflowmetry with maximum urinary flow (ml/s)(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(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)(1 year)
- Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of prostate volume (gr)(1 year)
- Efficacy of treatment in combination therapy group vs tamsulosin group in evaluation of post voided volume (ml)(1 year)
- Efficacy of treatment in combination therapy group vs peaprostil group and peaprostil group vs tamsulosin group in terms of Quality of life(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)(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(1 year)
研究者
Michele Billia
Medical doctor
Azienda Ospedaliero Universitaria Maggiore della Carita