Protocollo N 2014 - Benign Prostatic Hyperplasia

NCT06182189 | Recruiting

• 1 other identifier: 2014 - IPB
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasia; urology

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Patients with a benign prostatic hyperplasia condition

Patients with a benign prostatic hyperplasia condition

Other: Observation of patients with a benign prostatic hyperplasia condition

Interventions

Observation of patients with a benign prostatic hyperplasia condition OTHER

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

Patients with a benign prostatic hyperplasia condition

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
• subjects \>= 18 years old
• signature of informed consent

You may not qualify if:

• subjects \< 18 years
• presence of mental or physical disability that may prevent the patient from answering the questionnaires.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Andrea Salonia, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Salonia, MD

CONTACT

02 2643 5661; salonia.andrea@hsr.it

Alessia d'Arma, MSc

CONTACT

02 2643 5506; darma.alessia@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 26, 2023
• Study Start: December 1, 2014
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2034
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)