Benign Prostatic HyperplasiaNCT06182189
Protocollo N 2014 - Benign Prostatic Hyperplasia
An observational study of Benign Prostatic Hyperplasia, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Observation of patients with a benign prostatic hyperplasia condition
- How many people
- 8,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2014to 31 Dec 2034
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
Who may be able to join
- subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
- 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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Alessia d'Arma, MSc, 02 2643 5506, darma.alessia@hsr.it
About this study
Official title: Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
Read the detailed description
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
Data relating to the clinical conditions (state of the disease, psychological and related to the quality of life) of patients suffering from BPH under medical therapy and/or undergoing surgery will be collected within a specially designed database which will allow us to easily and secure extraction of data used for statistical analyzes in clinical research.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Observation of patients with a benign prostatic hyperplasia condition
- Keywords
- benign prostatic hyperplasia; urology
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of patients with a benign prostatic hyperplasia conditionOther
Observation of patients with a benign prostatic hyperplasia condition who have undergone surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with a benign prostatic hyperplasia condition | Patients with a benign prostatic hyperplasia condition Receives: Other: Observation of patients with a benign prostatic hyperplasia condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical history
- patient's medical history, past surgical history, family medical history, social history, allergies, medications;
Measured: Baseline
Psycho-behavioural data - male sexual health
Male sexual health assessed through the Questionnaire for the evaluation of male sexual health" MSHQ(25-item, range: 7 - 80, greater score indicating better function,
Measured: Baseline and up to 6 months
Physical examination - Body temperature
Body temperature detection (Celsius degree)
Measured: Baseline
Psycho-behavioural data - erectile function
Erectile function assessed through the "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
Prostatic Symptoms
Prostatic Symptoms assessed through the 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
Incontinence Symptoms
Incontinence Symptoms assessed through the ICIQ - International Consultation of Incontinence Questionnaire, ICIQ-SF has a 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
Physical examination - Body temperature pulse rate
Pulse rate detection (beats per minute)
Measured: Baseline
Physical examination - respiration assessment
Respiration rate detection (breaths per minute)
Measured: Baseline
Physical examination - blood pressure
Blood pressure detection (mmHg)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Dec 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
- Investigators
- Andrea Salonia, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182189
- Sponsor's protocol ID
- 2014 - IPB
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico
- ClinicalTrials.gov ID
- NCT06182189
- Acronym / sponsor ID
- 2014 - IPB
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia; urology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
Detailed description
Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.
Data relating to the clinical conditions (state of the disease, psychological and related to the quality of life) of patients suffering from BPH under medical therapy and/or undergoing surgery will be collected within a specially designed database which will allow us to easily and secure extraction of data used for statistical analyzes in clinical research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a benign prostatic hyperplasia condition | – | Other: Observation of patients with a benign prostatic hyperplasia conditionPatients with a benign prostatic hyperplasia condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
Key inclusion criteria (3 listed)
- subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
- subjects >= 18 years old
- signature of informed consent
Key exclusion criteria (2 listed)
- subjects < 18 years
- presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of patients with a benign prostatic hyperplasia conditionObservation of patients with a benign prostatic hyperplasia condition who have undergone surgery | Other | Patients with a benign prostatic hyperplasia condition |
Primary outcome
Medical history
Time frame: Baseline
- patient's medical history, past surgical history, family medical history, social history, allergies, medications;
Psycho-behavioural data - male sexual health
Time frame: Baseline and up to 6 months
Male sexual health assessed through the Questionnaire for the evaluation of male sexual health" MSHQ(25-item, range: 7 - 80, greater score indicating better function,
Physical examination - Body temperature
Time frame: Baseline
Body temperature detection (Celsius degree)
Psycho-behavioural data - erectile function
Time frame: Baseline and up to 6 months
Erectile function assessed through the "International Index of Erectile Function" questionnaire IIEF (scoring: 1 - 30 - 6-10: severe; 11-16: Moderate; 17-25: mild; 26-30: absence
Prostatic Symptoms
Time frame: Baseline and up to 6 months
Prostatic Symptoms assessed through the IPSS questionnaire, International Prostatic Symptoms Score: , Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms;
Incontinence Symptoms
Time frame: Baseline and up to 6 months
Incontinence Symptoms assessed through the ICIQ - International Consultation of Incontinence Questionnaire, ICIQ-SF has a maximum score of 21; the higher the score, the more severe is the UI, but there is no normal score;
Physical examination - Body temperature pulse rate
Time frame: Baseline
Pulse rate detection (beats per minute)
Physical examination - respiration assessment
Time frame: Baseline
Respiration rate detection (breaths per minute)
Physical examination - blood pressure
Time frame: Baseline
Blood pressure detection (mmHg)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Salonia, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, 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 26 Dec 2023. 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?
Medical history (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2023.