Benign Prostatic Hyperplasia
Conditions
Keywords
benign prostatic hyperplasia; urology
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.
Interventions
OTHERObservation of patients with a benign prostatic hyperplasia condition
Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical history | Baseline | \- patient's medical history, past surgical history, family medical history, social history, allergies, medications; |
| Psycho-behavioural data - male sexual health | 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, |
| Physical examination - Body temperature | Baseline | Body temperature detection (Celsius degree) |
| Psycho-behavioural data - erectile function | 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 |
| Prostatic Symptoms | 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; |
| Incontinence Symptoms | 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; |
| Physical examination - Body temperature pulse rate | Baseline | Pulse rate detection (beats per minute) |
| Physical examination - respiration assessment | Baseline | Respiration rate detection (breaths per minute) |
| Physical examination - blood pressure | Baseline | Blood pressure detection (mmHg) |
Countries
Italy
Contacts
Primary ContactAndrea Salonia, MD
Backup ContactAlessia d'Arma, MSc
Outcome results
None listed