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Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a benign prostatic hyperplasia condition | Patients with a benign prostatic hyperplasia condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation of patients with a benign prostatic hyperplasia condition | Other | Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medical history | - patient's medical history, past surgical history, family medical history, social history, allergies, medications; | Baseline |
| Psycho-behavioural data - male sexual health | 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, | Baseline and up to 6 months |
| Physical examination - Body temperature | Body temperature detection (Celsius degree) | Baseline |
| Psycho-behavioural data - erectile function | 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 | Baseline and up to 6 months |
| Prostatic Symptoms | 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; | Baseline and up to 6 months |
| Incontinence Symptoms | 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; | Baseline and up to 6 months |
| Physical examination - Body temperature pulse rate |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Salonia, MD | Contact | 02 2643 5661 | salonia.andrea@hsr.it | |
| Alessia d'Arma, MSc | Contact | 02 2643 5506 | darma.alessia@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Salonia, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Pulse rate detection (beats per minute) |
| Baseline |
| Physical examination - respiration assessment | Respiration rate detection (breaths per minute) | Baseline |
| Physical examination - blood pressure | Blood pressure detection (mmHg) | Baseline |
| D052801 |
| Male Urogenital Diseases |