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

NCT ID: NCT06193850

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-24

Study Completion Date

2045-01-31

Brief Summary

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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

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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.

Conditions

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Urologic Diseases Male Infertility Sexual Medicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Uro-andrologic patients

Subjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.

Observation during time

Intervention Type OTHER

Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions

Interventions

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Observation during time

Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Andrea Salonia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Salonia, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

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IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Salonia, MD

Role: CONTACT

02 2643 5661

Alessia d'Arma, PhD

Role: CONTACT

02 2643 5506

Facility Contacts

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Alessia d'Arma, MSc

Role: primary

02 2643 5506

Other Identifiers

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2014 Ambulatoriali

Identifier Type: -

Identifier Source: org_study_id

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