IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Location status: Recruiting
NCT Number: NCT06182189
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
Interested in participating?
Request Info18 year and older
Male
Observational
Milan, Lombardy, 20132, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery
Time frame: Baseline
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,
Time frame: Baseline
Body temperature detection (Celsius degree)
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
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;
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;
Time frame: Baseline
Pulse rate detection (beats per minute)
Time frame: Baseline
Respiration rate detection (breaths per minute)
Time frame: Baseline
Blood pressure detection (mmHg)
Contact information is provided by the study sponsor or research team.
Alessia d'Arma, MSc
CONTACT
Andrea Salonia, MD
CONTACT
IRCCS San Raffaele
Other
Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico
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.
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