Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 10:58 AM
Study NCT ID:
NCT06193850
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2045-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual function - Erectile Function', 'timeFrame': 'Baseline and up to 6 months', 'description': '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);'}, {'measure': 'Sexual function - premature ejaculation', 'timeFrame': 'Baseline and up to 6 months', 'description': 'Premature ejaculation investigated through PEDT questionnaire (; Scoring: 0 - 20. \\<=8 absence; 9-10 probable; \\>=11 premature ejaculation);'}, {'measure': 'Sexual function - male sexual health', 'timeFrame': 'Baseline and up to 6 months', 'description': '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);'}, {'measure': 'Sexual function - androgen deficiency', 'timeFrame': 'Baseline and up to 6 months', 'description': 'Androgen deficiency in elderly males investigated through ADAM questionnaire (range 10 - 50, 10 = absence and 50 = maximal,'}, {'measure': 'Sexual function - satisfaction with treatment of erection problems', 'timeFrame': 'Baseline and up to 6 months', 'description': 'satisfaction with treatment of erection problems investigated through EDITS questionnaire (range = 0-100; higher scores =more treatment satisfaction),'}, {'measure': 'Female sexual function', 'timeFrame': 'Baseline and up to 6 months', 'description': 'Female sexual function investigated through "Female Sexual Function Index" questionnaire - FSFI (range 2 - 36, lower scores = worse sexual functioning),;'}, {'measure': 'Sexual function - sexual distress', 'timeFrame': 'Baseline and up to 6 months', 'description': 'Sexual distress investigated through "Sexual Distress Scale" questionnaire - SDS (range 12- 48, sexual distress = \\> 15).'}], 'secondaryOutcomes': [{'measure': 'Prostate function - Prostatic Symptoms', 'timeFrame': 'Baseline and up to 6 months', 'description': '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'}, {'measure': 'Psychological state', 'timeFrame': 'Baseline and up to 6 months', 'description': '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.'}, {'measure': 'Prostate function - Incontinence Questionnaire', 'timeFrame': 'Baseline and up to 6 months', 'description': '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)'}, {'measure': 'Overactive Bladder', 'timeFrame': 'Baseline and up to 6 months', 'description': '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.'}, {'measure': 'Prostate function', 'timeFrame': 'Baseline and up to 6 months', 'description': 'Prostate function investigated through National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaire: total score range from 0 to 43, three subscales addressing pain (score range 0-21), urinary symptoms (score range 0-10), and quality of life (QOL) (score range 0-12)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male Infertility', 'urology', 'rare male cancer'], 'conditions': ['Urologic Diseases', 'Male Infertility', 'Sexual Medicine']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "The Department of Urology has been engaged for years in the field of medical and surgical research relating to benign and oncological pathologies of the prostate, kidney, excretory tract, testicle, as well as urinary continence and dysfunctions of the sexual and reproductive sphere. The accurate acquisition of clinical and psychometric data before and after any treatment, the follow-up analysis, the attention to the patient's global quality of life (QoL) in relation to the particular organic functions affected by the disease, are at the basis of all the medical advances that can be achieved to guarantee ever better care of the individual's health. In the context of urological clinical practice, outpatient activity plays a fundamental role. This activity, which ranges from general urology to sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology, allows us to come into contact with a large number of patients suffering from the most common uropathologies -andrological .\n\nNumerous studies have demonstrated how the treatment and outpatient management of such patients significantly impacts not only the underlying pathology but also their quality of life.\n\nThe outpatient management of the urological patient ranges from the recognition of the basic pathology to the diagnosis through the request for clinical-laboratory-instrumental investigations, to the possible indication for a medical or surgical treatment and to the follow-up of the patient.\n\nThe main objectives of this data archive are:\n\n1. Collect clinical, instrumental, laboratory, psychometric and sociodemographic data in patients suffering from a uro-andrological pathology who require a consultation in one of the clinics mentioned above.\n2. Collect data on the natural history of the pathologies in question and on the patients' quality of life in order to analyze the predictive factors of persistence and recurrence of symptoms, improvement or worsening of the clinical picture, and possible progression of the disease (both in benign and malignant form) and improve the care and treatment of the patients under examination.\n3. Having a follow-up and related studies with a number and above all an extension over time that, to date, is not present in the literature or in any scientific production."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.\n* subjects \\>= 18 years old\n* signature of informed consent\n\nExclusion Criteria:\n\n* \\- subjects \\< 18 years\n* presence of mental or physical disability that may prevent the patient from answering the questionnaires.'}, 'identificationModule': {'nctId': 'NCT06193850', 'briefTitle': 'Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Observational Study on the Quality of Life of Patients Attending General Urology, Sexual Medicine, Reproductive Medicine, Uro-oncology, Neuro-urology, Functional Urology Clinics', 'orgStudyIdInfo': {'id': '2014 Ambulatoriali'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uro-andrologic patients', 'description': 'Subjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.', 'interventionNames': ['Other: Observation during time']}], 'interventions': [{'name': 'Observation during time', 'type': 'OTHER', 'description': "Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions", 'armGroupLabels': ['Uro-andrologic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Alessia d'Arma, MSc", 'role': 'CONTACT', 'email': 'darma.alessia@hsr.it', 'phone': '02 2643 5506'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Andrea Salonia, MD', 'role': 'CONTACT', 'email': 'salonia.andrea@hsr.it', 'phone': '02 2643 5661'}, {'name': "Alessia d'Arma, PhD", 'role': 'CONTACT', 'email': 'darma.alessia@hsr.it', 'phone': '02 2643 5506'}], 'overallOfficials': [{'name': 'Andrea Salonia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrea Salonia', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}