Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Physical examination - blood pressure
研究概览
简要总结
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
详细描述
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
Data relating to the clinical conditions (state of the disease, psychological and related to the quality of life) of patients suffering from BPH under medical therapy and/or undergoing surgery will be collected within a specially designed database which will allow us to easily and secure extraction of data used for statistical analyzes in clinical research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
- •subjects >= 18 years old
- •signature of informed consent
排除标准
- •subjects < 18 years
- •presence of mental or physical disability that may prevent the patient from answering the questionnaires.
结局指标
主要结局
Physical examination - blood pressure
时间窗: Baseline
Blood pressure detection (mmHg)
Physical examination - Body temperature pulse rate
时间窗: Baseline
Pulse rate detection (beats per minute)
Physical examination - Body temperature
时间窗: Baseline
Body temperature detection (Celsius degree)
Prostatic Symptoms
时间窗: Baseline and up to 6 months
Prostatic Symptoms assessed through the IPSS questionnaire, International Prostatic Symptoms Score: , Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms;
Psycho-behavioural data - male sexual health
时间窗: Baseline and up to 6 months
Male sexual health assessed through the Questionnaire for the evaluation of male sexual health" MSHQ(25-item, range: 7 - 80, greater score indicating better function,
Psycho-behavioural data - erectile function
时间窗: Baseline and up to 6 months
Erectile function assessed through the "International Index of Erectile Function" questionnaire IIEF (scoring: 1 - 30 - 6-10: severe; 11-16: Moderate; 17-25: mild; 26-30: absence
Incontinence Symptoms
时间窗: Baseline and up to 6 months
Incontinence Symptoms assessed through the ICIQ - International Consultation of Incontinence Questionnaire, ICIQ-SF has a maximum score of 21; the higher the score, the more severe is the UI, but there is no normal score;
Medical history
时间窗: Baseline
- patient's medical history, past surgical history, family medical history, social history, allergies, medications;
Physical examination - respiration assessment
时间窗: Baseline
Respiration rate detection (breaths per minute)
次要结局
未报告次要终点
研究者
Andrea Salonia
Professor
IRCCS San Raffaele