Protocollo N 2014 - Benign Prostatic Hyperplasia

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

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

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Other: Observation of patients with a benign prostatic hyperplasia condition

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 Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Andrea Salonia, MD; Phone Number: 02 2643 5661; Email: salonia.andrea@hsr.it
• Study Contact Backup: Name: Alessia d'Arma, MSc; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Alessia d'Arma, MSc; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with a benign prostatic hyperplasia condition	Other: Observation of patients with a benign prostatic hyperplasia condition; Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Andrea Salonia, MD, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: benign prostatic hyperplasia; urology
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 2014 - IPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No