Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorIRCCS San Raffaele
About this trial
Prospective observational study on the quality of life of patients attending general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.The data relating to the clinical conditions (disease state, psychological and related to quality of life) of the patients belonging to the above-mentioned clinics will be collected in a specially designed database which will allow us to extract the data in a simple and safe way used for statistical analyses. in clinical research.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
subjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.
subjects >= 18 years old
signature of informed consent
Disqualifiers
- subjects < 18 years
presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Trial population
The patient population of interest is characterised by: patients who came for outpatient visits to the general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observation during time
Other interventionEvaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Uro-andrologic patients1 intervention
Trial outcomes
Primary outcomes
1
Sexual function - Erectile Function
Sexual function investigated through: "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 months2
Sexual function - premature ejaculation
Premature ejaculation investigated through PEDT questionnaire (; Scoring: 0 - 20. \<=8 absence; 9-10 probable; \>=11 premature ejaculation);
Time frame
Baseline and up to 6 months3
Sexual function - male sexual health
Male sexual health investigated through MSHQ questionnaire (25-item, range: 7 - 80, greater score indicating better function and through Androtest (1 - 32; \> 8 = out of the norm);
Time frame
Baseline and up to 6 months4
Sexual function - androgen deficiency
Androgen deficiency in elderly males investigated through ADAM questionnaire (range 10 - 50, 10 = absence and 50 = maximal,
Time frame
Baseline and up to 6 monthsSecondary outcomes
1
Prostate function - Prostatic Symptoms
Prostatic Symptoms investigated through 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 months2
Psychological state
Psychological state investigated through Beck Beck Depression Inventory: Range score 1 - 63; 1-10: normal; 11-16: Mild mood disturbance; 17-20: Borderline clinical depression; 21-30: Moderate depression; 31-40: Severe depression; over 40: Extreme depression.
Time frame
Baseline and up to 6 months3
Prostate function - Incontinence Questionnaire
Incontinence Questionnaire investigated through ICIQ-SF questionnaire (maximum score of 21; the higher the score, the more severe is the UI, but there is no normal score)
Time frame
Baseline and up to 6 months4
Overactive Bladder
Overactive Bladder investigated through OAB-q - Overactive Bladder Questionnaire: the score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. Higher scores indicate more severe symptoms or better quality of life.
Time frame
Baseline and up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov