An interventional study of Prostatic Artery Embolization in Hyperplasia Prostatic, Lower Urinary Tract Symptoms and Prostatic Diseases, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to male participants. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
The aim of this study is to investigate the safety and efficacy of prostatic artery embolization (PAE) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.
This is a prospective study investigating the safety and efficacy of PAE for patients who refuse or are not eligible for surgery and who suffers from moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostatic obstruction due to benign prostatic hyperplasia. It may form the grounding for further research in the shape of a larger randomised clinical trial.
Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS 6 months post-procedure.
1, and 6 months follow-up.
Main outcome Ability to void after removal of indwelling catheter
Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's enrollment of 11 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.
Procedure: Prostatic Artery Embolization
The procedure is performed with the patient under local anaesthetic and if necessary sedation. We will be using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation will be done using microspherical embolic material.
Ability to void spontaneously
Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months
Time frame: 6 months
IPSS
International Prostate Symptom Score from 0-35, 35 is most severe symptoms
Time frame: 1, 6 months
QoL
Quality of Life scored from 0-6, 6 is worst
Time frame: 1, 6 months
IIEF
International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function
Time frame: 1, 6 months
PV
Prostate Volume measured by MRI
Time frame: 1, 6 months
PVR
Post-void residual
Time frame: 1, 6 months
Qmax
Peak void flow
Time frame: 1, 6 months
PSA
Prostate-specific antigen
Time frame: 1, 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Dec 2018, 20 months.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 20 months is below that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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