Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation during time.
- Who it may be relevant to
- Registry conditions: Urologic Diseases, Male Infertility, Sexual Medicine. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Observation during time
Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions
Primary outcome measures
- Sexual function - Erectile Function [Time frame: Baseline and up to 6 months]
- Sexual function - premature ejaculation [Time frame: Baseline and up to 6 months]
- Sexual function - male sexual health [Time frame: Baseline and up to 6 months]
- Sexual function - androgen deficiency [Time frame: Baseline and up to 6 months]
- Sexual function - satisfaction with treatment of erection problems [Time frame: Baseline and up to 6 months]
- Female sexual function [Time frame: Baseline and up to 6 months]
- Sexual function - sexual distress [Time frame: Baseline and up to 6 months]
Secondary outcome measures (5)
- Prostate function - Prostatic Symptoms [Time frame: Baseline and up to 6 months]
- Psychological state [Time frame: Baseline and up to 6 months]
- Prostate function - Incontinence Questionnaire [Time frame: Baseline and up to 6 months]
- Overactive Bladder [Time frame: Baseline and up to 6 months]
- Prostate function [Time frame: Baseline and up to 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT06193850 · 2014 Ambulatoriali