Protocollo N 2014 - Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.

Detailed Description
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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.

Official Title
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Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Other: Observation of patients with a benign prostatic hyperplasia condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with a benign prostatic hyperplasia condition<br>Patients with a benign prostatic hyperplasia condition | Other: Observation of patients with a benign prostatic hyperplasia condition<br>* Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign prostatic hyperplasia; urology