Clinical trial NCT06193850: Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urologic Diseases
Male Infertility
Sexual Medicine
Keywords: Male Infertility
urology
rare male cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 10000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sexual function - Erectile Function
timeFrame: Baseline and up to 6 months
measure: Sexual function - premature ejaculation
timeFrame: Baseline and up to 6 months
measure: Sexual function - male sexual health
timeFrame: Baseline and up to 6 months
measure: Sexual function - androgen deficiency
timeFrame: Baseline and up to 6 months
measure: Sexual function - satisfaction with treatment of erection problems
timeFrame: Baseline and up to 6 months
measure: Female sexual function
timeFrame: Baseline and up to 6 months
measure: Sexual function - sexual distress
timeFrame: Baseline and up to 6 months
Secondary outcomes:
measure: Prostate function - Prostatic Symptoms
timeFrame: Baseline and up to 6 months
measure: Psychological state
timeFrame: Baseline and up to 6 months
measure: Prostate function - Incontinence Questionnaire
timeFrame: Baseline and up to 6 months
measure: Overactive Bladder
timeFrame: Baseline and up to 6 months
measure: Prostate function
timeFrame: Baseline and up to 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Andrea Salonia, MD
role: PRINCIPAL_INVESTIGATOR
References: