An interventional study of Prostatic Arterial Embolization and Sham procedure in Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Benign and Genital Diseases, Male, sponsored by João Martins Pisco. Completed at 1 site in Portugal. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by João Martins Pisco · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether prostatic arterial embolization (PAE) compared is an effective and safe treatment for benign prostatic hyperplasia in patients with severe lower urinary tract symptoms not adequately controlled by medical therapy with alpha-blockers, as assessed by the the International Prostate Symptom Score (IPSS) after 6 months. Patients will be randomized on a 1:1 ratio to PAE or to a sham procedure and evaluated at 1, 3 and 6 months. Patients randomized to the sham procedure will be offered the possibility of performing PAE after 6 months. All patients may participate on an optional 6-months extension study.
This is a randomized, parallel-group, evaluator-blind, superiority, controlled clinical trial of PAE versus a sham procedure in patients with BPH with severe LUTS not adequately controlled by medical therapy with alpha-blockers.
This study has a screening visit at day -14, a baseline visit at day -2, a randomization and intervention visit at day 0, follow up visits at months 1, 3 and 6.
Patients initially randomized to the sham procedure and who completed the 6 month follow-up period will be offered the possibility of performing PAE at no cost. All patients will be invited to participate in a 6 months post-trial extension study.
Patients over 45 years-old with a diagnosis of BPH associated with severe LUTS defined by an IPSS>=20 after a minimum of 6 months treatment with alpha-blockers and with a prostate volume ≥ 40 mL will start a two weeks screening period. Eligible patients will be started either tamsulosin 0.4 mg q.d., alfuzosin 10 mg q.d. or silodosin 8 mg q.d., which will be maintained throughout the study period, and have the intervention scheduled for the following 2 days (study day 0), when they will be randomized to PAE or to a sham procedure if the procedure is technically feasible
Those patients in whom angiography has shown that PAE is technically feasible will be randomized to one of the study arms on a 1:1 ratio. Patients in both groups will be submitted to exactly the same procedure, except that patients randomized to the control group will not be injected with polyvinyl alcohol particles. Patients will be discharged as soon as their clinical condition is stabilized
Patients will be assessed at 1, 3 and 6 months with IPSS, QoL, IIEF, BPH-II and will perform prostatic ultrasonography, uroflowmetry and PSA at month 1 and 6. At 1 month a pelvic NMR will be performed to evaluate prostate volume and the degree of ischemia.
Patients completing the 6 month follow-up period will be invited to enter a 6 months extension study. In this extension study, patients will be evaluated at month 12 for all efficacy variables. Patients initially randomized to the sham procedure who wanted to perform PAE after the conclusion of the trial will be evaluated only at months 1, 3 and 6 after PAE.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's enrollment of 80 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →This is the only study on the registry with João Martins Pisco as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Selective catheterization of the prostatic arteries followed by slow injection of Bead Block 300-500 or PVA 100+200 micra particles under fluoroscopic control.
Procedure: Prostatic Arterial Embolization
Selective catheterization of the prostatic arteries followed by removal of the catheter with no particles injected.
Procedure: Sham procedure
The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. Bead Block 300-500 or PVA 100+200 micra particles are slowly injected under fluoroscopic control until the end point is reached. Embolization is considered finished when there is "near stasis" in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification checked in both oblique and AP views. Upon finishing the embolization of the left prostatic arteries, the right prostatic arteries are embolized in the same way.
The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. The catheter is removed and no particles are injected.
Change from baseline in the International Prostate Symptom Score
The difference between the baseline value and the value observed at the last valid observation of a validated questionnaire that measures the disconfort caused by lowere urinary tract symptoms
Time frame: 6 months
Disease specific quality of life question of the International Prostate Symptom Score
The score of a question on the IPSS questionnare that measures quality of life in subjects with lower urinary tract symptoms at the last valid observation in each subject
Time frame: 6 months
Change from baseline in the Benign Prostatic Hyperplasia Impact Index (BPH-II)
The difference between the baseline value and the value observed at the last valid observation on a validated questionnaire that measures the disconfort caused by lowere urinary tract symptoms
Time frame: 6 months
Change from baseline in the International Index of Erectile Function (IIEF)
The difference between the baseline value and the value observed at the last valid observation on a validated questionnaire that measures the severity of erectile disfunction
Time frame: 6 months
Change from baseline in the peak urinary flow rate (Qmax)
The difference between the baseline value and the value observed at the last valid observation of the maximum flow rate of the urinary stream by uroflowmetry
Time frame: 6 months
Change from baseline in the post-void residual volume
TThe difference between the baseline value and the value observed at the last valid observation of he volume of urine in the bladder after a complete voiding assessed by uroflowmetry
Time frame: 6 months
Change from baseline in prostate volume
The difference between the baseline value and the value observed at the last valid observation of prostate volume measured by transrectal ultrasonography
Time frame: 6 months
Change from baseline in the Prostate Specific Antigen (PSA)
The difference between the baseline value and the value observed at the last valid observation of PSA.
Time frame: 6 months
Plan to share: Yes — Deidentified participant data and data dictionary of all the study data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: From January 2020
Access criteria: Deidentified participant data and data dictionary will be made available upon request to oliveira.amg@gmail.com with the submission of a study protocol and subsequent approval by the Research Ethics Committee of the institution where the trial was conducted.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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