Hyperplasia Prostatic, Lower Urinary Tract Symptoms, Prostatic Diseases, Urological Manifestations
Conditions
Keywords
Benign prostatic obstruction, benign prostatic enlargement, benign prostatic hyperplasia, prostatic artery embolization, Quality of Life, IPSS, DAN-PSS, Complications
Brief summary
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.
Detailed description
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)
Interventions
PROCEDUREProstatic 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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or * Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment * Unsuitable for TURP or refuse surgery
Exclusion criteria
* Bladder dysfunction(and known neurological conditions affecting bladder function) * Urethral strictures * Bladder neck contracture * Known sphincter anomalies * Big bladder diverticulum or stones * Kidney insufficiency (eGFR \< 45) * Coagulation disturbances * Severe atheromatous or tortuosity of arteries * Allergy to contrast medium * Unable to undergo MR imaging * Urological malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to void spontaneously | 6 months | Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL | 1, 6 months | Quality of Life scored from 0-6, 6 is worst |
| IIEF | 1, 6 months | International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function |
| PV | 1, 6 months | Prostate Volume measured by MRI |
| IPSS | 1, 6 months | International Prostate Symptom Score from 0-35, 35 is most severe symptoms |
| Qmax | 1, 6 months | Peak void flow |
| PSA | 1, 6 months | Prostate-specific antigen |
| PVR | 1, 6 months | Post-void residual |
Countries
Denmark
Outcome results
None listed