Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients

Urologic Diseases Clinical Trial

Official title:

Observational Study on the Quality of Life of Patients Attending General Urology, Sexual Medicine, Reproductive Medicine, Uro-oncology, Neuro-urology, Functional Urology Clinics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193850
• Other study ID #: 2014 Ambulatoriali
• Status: Recruiting
• Start date: February 24, 2015
• Est. completion date: January 31, 2045

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Andrea Salonia, MD
• Phone: 02 2643 5661
• Email: salonia.andrea[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 .

Numerous 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.

The 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.

The main objectives of this data archive are:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 31, 2045
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• - subjects < 18 years

• presence of mental or physical disability that may prevent the patient from answering the questionnaires.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility
• Urologic Diseases

Intervention

Other:
• Observation during time
Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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);	Baseline and up to 6 months
Primary	Sexual function - premature ejaculation	Premature ejaculation investigated through PEDT questionnaire (; Scoring: 0 - 20. <=8 absence; 9-10 probable; >=11 premature ejaculation);	Baseline and up to 6 months
Primary	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);	Baseline and up to 6 months
Primary	Sexual function - androgen deficiency	Androgen deficiency in elderly males investigated through ADAM questionnaire (range 10 - 50, 10 = absence and 50 = maximal,	Baseline and up to 6 months
Primary	Sexual function - satisfaction with treatment of erection problems	satisfaction with treatment of erection problems investigated through EDITS questionnaire (range = 0-100; higher scores =more treatment satisfaction),	Baseline and up to 6 months
Primary	Female sexual function	Female sexual function investigated through "Female Sexual Function Index" questionnaire - FSFI (range 2 - 36, lower scores = worse sexual functioning),;	Baseline and up to 6 months
Primary	Sexual function - sexual distress	Sexual distress investigated through "Sexual Distress Scale" questionnaire - SDS (range 12- 48, sexual distress = > 15).	Baseline and up to 6 months
Secondary	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	Baseline and up to 6 months
Secondary	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.	Baseline and up to 6 months
Secondary	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)	Baseline and up to 6 months
Secondary	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.	Baseline and up to 6 months
Secondary	Prostate function	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)	Baseline and up to 6 months