Protocollo N 2014 - Benign Prostatic Hyperplasia

Recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Other: Observation of patients with a benign prostatic hyperplasia condition

• Registration Number: NCT06182189
• Lead Sponsor: IRCCS San Raffaele

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 Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2023-11-21
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Primary Completion: 2024-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 8000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a benign prostatic hyperplasia condition	Observation of patients with a benign prostatic hyperplasia condition	Patients with a benign prostatic hyperplasia condition

Primary Outcome Measures

Name	Time	Method
Physical examination - blood pressure	Baseline	Blood pressure detection (mmHg)
Physical examination - Body temperature pulse rate	Baseline	Pulse rate detection (beats per minute)
Physical examination - Body temperature	Baseline	Body temperature detection (Celsius degree)
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;
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,
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
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;
Medical history	Baseline	- patient's medical history, past surgical history, family medical history, social history, allergies, medications;
Physical examination - respiration assessment	Baseline	Respiration rate detection (breaths per minute)

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy