Protocollo N 2014 - Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182189
• Other study ID #: 2014 - IPB
• Status: Recruiting
• Start date: December 1, 2014
• Est. completion date: December 31, 2034

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Andrea Salonia, MD
• Phone: 02 2643 5661
• Email: salonia.andrea[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Other:
• Observation of patients with a benign prostatic hyperplasia condition
Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

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