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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases; Male Infertility; Sexual Medicine
• Intervention / Treatment: Other: Observation during time

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Andrea Salonia, MD; Phone Number: 02 2643 5661; Email: salonia.andrea@hsr.it
• Study Contact Backup: Name: Alessia d'Arma, PhD; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Alessia d'Arma, MSc; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uro-andrologic patients; Subjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.	Other: Observation during time; Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Andrea Salonia, MD, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2015
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): January 31, 2045

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Male Infertility; urology; rare male cancer
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male; Urologic Diseases
• Other Study ID Numbers: 2014 Ambulatoriali

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No