Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06182189

Protocollo N 2014 - Benign Prostatic Hyperplasia

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location status: Recruiting

Location contact

Alessia d'Arma, MSc

CONTACT

[email protected]

02 2643 5506

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observation of patients with a benign prostatic hyperplasia condition

Other

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

Primary outcomes

  1. Medical history

    Time frame: Baseline

    • patient's medical history, past surgical history, family medical history, social history, allergies, medications;
  2. Psycho-behavioural data - male sexual health

    Time frame: 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,

  3. Physical examination - Body temperature

    Time frame: Baseline

    Body temperature detection (Celsius degree)

  4. Psycho-behavioural data - erectile function

    Time frame: 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

  5. Prostatic Symptoms

    Time frame: 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;

  6. Incontinence Symptoms

    Time frame: 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;

  7. Physical examination - Body temperature pulse rate

    Time frame: Baseline

    Pulse rate detection (beats per minute)

  8. Physical examination - respiration assessment

    Time frame: Baseline

    Respiration rate detection (breaths per minute)

  9. Physical examination - blood pressure

    Time frame: Baseline

    Blood pressure detection (mmHg)

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia d'Arma, MSc

CONTACT

[email protected]

02 2643 5506

Andrea Salonia, MD

CONTACT

[email protected]

02 2643 5661

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2024
Study completion
2034
First posted
Dec 26, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.