Urology
TEACHING
RESIDENT TRAINING
Service accredited by the Ministry of Health, Consumption and Social Welfare and by the National Commission of the Speciality for the training of Resident Interns, with two places per year.
It also takes part in training for resident physicians in the specialities Family and Community Medicine, Nephrology, Radiation Oncology, Gynaecology and General and Digestive Surgery in their rotations within the Urology Service and for external interns from other hospitals.
The Service also takes part in training for Primary Care Nurse Residents
UAM MEDICINE DEGREE TEACHING
Theory-based and practical teaching of the subject Urology for year-4 students in the Degree in Medicine at Universidad Autónoma de Madrid.
SERVICE AND INTERDEPARTMENTAL SESSIONS
Three clinical sessions are held every week, with the following topics:
- Clinical-care session (twice a week)
- General session (weekly)
- Resident Physician session (weekly)
- Uro-Infectious session (monthly)
- Uro-Gynaecological session (bimonthly)
- Andrology and Infertility session (bimonthly)
- Uro-Oncology session (monthly)
- Uro-Nephrology session (monthly)
- Lithiasis and Endourology session (monthly)
In addition to participation in two multidisciplinary committees:
- Uro-oncological committee (weekly)
- Infertility committee (monthly)
- Urinary lithiasis committee (monthly)
- Pelvic floor committee
FACE-TO-FACE AND ONLINE TRAINING ACTIVITIES
Specific face-to-face training activities (congresses, workshops, seminars) and multidisciplinary training inside and outside the hospital.
Online courses within the Jiménez Díaz classroom and other recommended online courses.
In-house courses such as Transplant-Thiel, Endourology Workshops or participation in teaching projects of the European Board of Urology such as the EBUiS Madrid project.
RESEARCH
The Urology Unit currently manages 5 clinical trials and takes part in over 10 clinical studies in collaboration with other private and public entities.
Unit: Uro-Oncology
Area: Prostate cancer
Phase III Multinational, randomised, double-masked, controlled phase III study on the efficacy and safety of ODM-201 in men with Castration-Resistant High-Risk Non-Metastatic Prostate Cancer.
The aim of this study is to demonstrate the safety and efficacy of the drug ODM-201, administered orally, compared to a placebo in patients with prostate cancer who have relapsed despite hormonal therapy, but with no indication of metastasis.
https://clinicaltrials.gov/ct2/show/NCT02200614?term=ARAMIS
Unit: Uro-Functional
Area: Bladder - Interstitial Cystitis
Phase 2a Randomised, double-blind, placebo-controlled, parallel-group, proof-of-concept study to investigate the efficacy, safety, pharmacodynamics and pharmacokinetics of ASP6294 in treating women with painful bladder syndrome/interstitial cystitis.
The aim of this study is to evaluate the efficacy and safety of a new drug (ASP6294) to reduce bladder pain and urinary discomfort resulting from the disorder "painful bladder syndrome/interstitial cystitis".
Unit: Uro-Functional
Area: Bladder
European study of Altis®, a single-incision sling system to treat female stress urinary incontinence
The aim of this study is to collect additional information on the efficacy and safety of the ALTIS SIS® female suburethral sling in the medium (1 year) and long term (up to 3 years) and to compare satisfaction rates before and after operations involving patients with stress urinary incontinence.
https://clinicaltrials.gov/ct2/show/NCT02049840?cond=Urinary+Incontinence%2CStress&cntry=ES&rank=
Unit: Uro-Lithiasis
Area: Kidney-Enteric Hyperoxaluria
Phase III, randomised, placebo-controlled study to evaluate the safety and efficacy of ALLN-177 in patients with enteric hyperoxaluria.
The aim of this study is to evaluate the safety and efficacy of a new drug in treating patients with enteric hyperoxaluria, i.e. patients who present an elevated concentration of oxalic acid in urine as a consequence of an excess of oxalic acid absorption at colon level, among other causes.
https://clinicaltrials.gov/ct2/show/NCT03456830?term=ALLN-177&rank=2
Unit: Uro-Oncology
Area: Bladder cancer
Impact of preoperative intravesical administration of mitomycin-C (MMC) by electromotive instillation (EMDA) in patients with non-muscle invasive bladder tumour (NMIBT). Prospective randomised study.
The aim of this study is to evaluate the rate of recurrence and/or progression and free time until the first event in NIMBC patients receiving MMC+EMDA prior to TUR compared to instillation after TUR.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003680-11/ES#G
Randomised, open-label clinical trial to evaluate the efficacy of four analgesia and comfort protocols in patients undergoing extracorporeal shockwave lithotripsy (ESWL).
Clinical trials
Clinical Trials are Research Studies involving people willing to test new drugs and/or treatments to prevent, diagnose or treat a disease. Successful treatments, which currently cure billions of people, are based on results from previous clinical trials.
A clinical trial presents an additional treatment option for patients' conditions, whose participation is always voluntary.
What kind of clinical trials are there?
Clinical trials can be classified in a range of ways. Depending on their purpose, tests include: treatment, prevention, detection, diagnosis, registration and quality of life (QoL) studies.
However, the most well-known classification is based on the phase of clinical development of the new drug or treatment in which the trials are conducted. There are:
- PHASE I TRIALS: The optimal safe dosage for administration of the new drug or treatment is sought by studying its tolerability in a small cohort (between 20-80) of healthy volunteers.
- PHASE II TRIALS: The aim is to define the therapeutic dose, efficacy and safety of the new drug or treatment in hundreds of patients with the disease in question. They are usually short trials, but very restrictive when it comes to participation.
- PHASE III TRIALS: They confirm safety and efficacy in a large number of patients at the therapeutic dose clearly defined in Phase II, and test whether the new drug is better than those commonly used. These trials are longer, but more flexible in their inclusion and exclusion criteria.
- There are also Phase IIIb trials that evaluate new formulations, administration routes or new indications for treatments previously approved and marketed.
- PHASE IV TRIALS: In which the side effects of long-term treatments are studied. Safety in real-world conditions of use in populations with a large number of subjects.
Why should I take part in a study?
There are several reasons to take part in a research study: to gain access to new research treatments that could help you with your disease; the ability to play a more active role in your healthcare and learn more about your disease; and, most importantly, to contribute to clinical research into new treatment options for the future.
However, it should be remembered that participation in a clinical trial is a personal, voluntary, non-transferable decision. You should reach an independent decision after carefully evaluating the information provided by the research staff, and have the freedom to withdraw from the study at any time, without the need to provide explanations, and without any negative consequences for your future medical care within the Urology Department.
What happens during a clinical trial?
A clinical trial generally has 4 phases: a pre-screening phase, a screening phase, a treatment phase, and finally a follow-up phase.
In the Pre-Screening Phase, the physician will explain the study procedures and the benefits and risks, and address any questions you have before giving your official consent to take part.
You should read and sign an informed consent form to indicate that you understand the study and what is required. No procedure may be performed until consent has been given.
Once you have signed the informed consent form, you will be interviewed during the Screening Phase about your medical history and all medications you are currently taking. You will undergo screening examinations, tests, procedures and physical examinations according to the requirements of each particular study, with your participation in the study starting once all tests and screening procedures have been completed and you are deemed eligible to continue according to the study protocol.
Based on the results of the examination, some patients may not meet the requirements and may be ineligible to take part in the study.
Once the screening process is complete, the so-called Treatment Phase will begin. You will be assigned the treatment in question (or placebo) following the trial procedures, and will make regular site visits as outlined in the study protocol. Your compliance with taking the study drug will be assessed throughout the study, and additional tests may be required, depending on the study.
Throughout the trial, the research staff will provide continuous support and work with you to schedule convenient visit times. Any questions or concerns can be discussed with the team, who will be on hand at all times to answer them.
At the end of the study, as part of the follow-up or end-of-trial phase, the physician will perform a final evaluation, including a physical examination, and make any recommendations for follow-up.
What is placebo?
A placebo is a substance or treatment that closely resembles the authentic treatment being tested, but lacks the essential active ingredient as it has been intentionally designed to have no therapeutic effect.
For instance, if the genuine study treatment is a syrup with a specific colour and flavour, the placebo will be formulated to mimic the same colour and flavour but without the active drug.
How is it decided who gets the treatment and who receives the placebo?
The study physician does not decide who receives the placebo and who receives the treatment. The study treatment is randomly assigned by a computer.
Your physician will assess your eligibility for the study, and you will have the same likelihood as the other participants of receiving the study placebo.
Will my physician know which group I am in?
Most research studies are "double-blind". This means that neither you nor your physician will know which group you have been assigned to.
The "masking" process is crucial to prevent any potential bias, ensuring that your perception or expectation of receiving the study treatment does not influence your well-being, and to ensure that researchers treat you in the same way as someone receiving the placebo.
However, your physician will have this information readily available to assess any unforeseen circumstances in the event of an emergency.
Will the study treatment make me feel better?
Some people take part in research studies in the hope of feeling better, but this outcome is not assured. Not all treatments work for everyone. For example, some people get better when they take acetaminophen for headache pain, but others do not.
This means the effectiveness of the new treatment in improving your condition cannot be determined until the study is complete.
What if I want to leave the trial?
All patients taking part in a trial do so voluntarily, and leaving is also voluntary. You can choose whether to remain or leave at any time. Inform the Uro-Research Unit, which will refer you to your treating urologist, who will inform you if there are other treatment options. Remember that your healthcare relationship will not change because of your decision.
Is it safe to take part in a Clinical Trial?
Patient safety is the first concern in clinical trials. That is why legislation on medicinal products and clinical trials in the European Union is among the most comprehensive to date.
All drugs or treatments evaluated in these studies undergo rigorous safety measures and are administered with the approval and oversight of local ethics committees, the Spanish Agency for Medicines and, in the case of international studies, the respective regulatory committees and agencies. All clinical trials conducted in our unit are accredited according to the specific legislation in force and comply with international ethical standards of excellence, known as the Declaration of Helsinki, and the standardised procedures of Good Clinical Practice. Physicians and staff must comply with the Declaration in order to keep you and other participants as safe as possible throughout the trial.
The study sponsor is also required to have insurance or another financial guarantee to cover any damages suffered by participants in the trial.
How can I take part in a Clinical Trial?
Clinical trials are conducted under the strictest patient safety and control measures. That is why taking part in a Clinical Trial requires a series of requirements describing the eligibility (Inclusion Criteria) and non-eligibility (Exclusion Criteria) to be met.
The criteria are set out in the study protocol, and must be met in order to guarantee the success of the clinical trial, protect participants from side effects (collateral), and minimise risks.
The inclusion criteria define the specific characteristics required of an individual in order to take part in the trial, while the exclusion criteria are used to safeguard individuals from receiving a treatment that may not be beneficial in their particular case.
These criteria include factors such as:
- Age
- Gender
- Clinical phase of the disease
- Previous treatments received: whether they have been successful or not
- Current treatment
- Analytical results and imaging tests
Once you are pre-selected for the trial, your treating urologist will generally refer you directly to the Uro-Research Unit.
Available files
Hospital Universitario Fundación Jiménez Díaz
Avda. Reyes Católicos, 2
28040 Madrid Madrid
