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Urologic DiseasesNCT06193850

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

An observational study of Urologic Diseases and Male Infertility, run by IRCCS San Raffaele at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
Observation during time
How many people
10,000 participants
Where
1 siteItaly
Study dates
24 Feb 2015to 31 Jan 2045
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • - subjects < 18 years
  • presence of mental or physical disability that may prevent the patient from answering the questionnaires.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Salonia, MD contact

02 2643 5661

salonia.andrea@hsr.it

Alessia d'Arma, PhD contact

02 2643 5506

darma.alessia@hsr.it

Italy1 site, 1 recruiting

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

    Alessia d'Arma, MSc, 02 2643 5506, darma.alessia@hsr.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.
Being tested
Observation during time
Keywords
Male Infertility, urology, rare male cancer
Medical subject headings
Urologic Diseases, Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observation during timeOther

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

Study groups in NCT06193850
Study groupRoleWhat they receive
Uro-andrologic patientsSubjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.
Receives: Other: Observation during time

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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);

    Measured: Baseline and up to 6 months

  2. Sexual function - premature ejaculation

    Premature ejaculation investigated through PEDT questionnaire (; Scoring: 0 - 20. <=8 absence; 9-10 probable; >=11 premature ejaculation);

    Measured: Baseline and up to 6 months

  3. 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);

    Measured: Baseline and up to 6 months

  4. Sexual function - androgen deficiency

    Androgen deficiency in elderly males investigated through ADAM questionnaire (range 10 - 50, 10 = absence and 50 = maximal,

    Measured: Baseline and up to 6 months

  5. 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),

    Measured: Baseline and up to 6 months

  6. Female sexual function

    Female sexual function investigated through "Female Sexual Function Index" questionnaire - FSFI (range 2 - 36, lower scores = worse sexual functioning),;

    Measured: Baseline and up to 6 months

  7. Sexual function - sexual distress

    Sexual distress investigated through "Sexual Distress Scale" questionnaire - SDS (range 12- 48, sexual distress = > 15).

    Measured: Baseline and up to 6 months

Secondary outcomes (5)

  1. 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

    Measured: Baseline and up to 6 months

  2. 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.

    Measured: Baseline and up to 6 months

  3. 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)

    Measured: Baseline and up to 6 months

  4. 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.

    Measured: Baseline and up to 6 months

  5. 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)

    Measured: Baseline and up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start24 Feb 2015
  3. Primary completionFeb 2025 (estimated)
  4. Study completion31 Jan 2045 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06193850
Sponsor's protocol ID
2014 Ambulatoriali
Status last verified
Dec 2023
First submitted
21 Nov 2023
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urologic Diseases and Male Infertility, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Salonia, MD (02 2643 5661, salonia.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexual function - Erectile Function (time frame: Baseline and up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06193850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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