Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 8,000
- Locations
- 1
- Primary Endpoint
- Physical examination - blood pressure
Study Overview
Brief Summary
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
- •subjects >= 18 years old
- •signature of informed consent
Exclusion Criteria
- •subjects < 18 years
- •presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Outcomes
Primary Outcomes
Physical examination - blood pressure
Time Frame: Baseline
Blood pressure detection (mmHg)
Physical examination - Body temperature pulse rate
Time Frame: Baseline
Pulse rate detection (beats per minute)
Physical examination - Body temperature
Time Frame: Baseline
Body temperature detection (Celsius degree)
Prostatic Symptoms
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline
- patient's medical history, past surgical history, family medical history, social history, allergies, medications;
Physical examination - respiration assessment
Time Frame: Baseline
Respiration rate detection (breaths per minute)
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Salonia
Professor
IRCCS San Raffaele