Protocollo N 2014 - Benign Prostatic Hyperplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation of patients with a benign prostatic hyperplasia condition.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico
Overview
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
- Other Observation of patients with a benign prostatic hyperplasia condition
Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery
Primary outcome measures
- Medical history [Time frame: Baseline]
- Psycho-behavioural data - male sexual health [Time frame: Baseline and up to 6 months]
- Physical examination - Body temperature [Time frame: Baseline]
- Psycho-behavioural data - erectile function [Time frame: Baseline and up to 6 months]
- Prostatic Symptoms [Time frame: Baseline and up to 6 months]
- Incontinence Symptoms [Time frame: Baseline and up to 6 months]
- Physical examination - Body temperature pulse rate [Time frame: Baseline]
- Physical examination - respiration assessment [Time frame: Baseline]
- Physical examination - blood pressure [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT06182189 · 2014 - IPB