Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity. The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established TUR-P.

Official Title
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Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Prostatic artery embolization
* Procedure: monopolar transurethral prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men older than 40 Patient must be a candidate for TURP Refractory to medical therapy or patient is not willing to consider (further) medical treatment Patient has a prostate size of at least 25 ml and not more than 80 ml, measured by ultrasound IPSS ≥8 QoL ≥3 Qmax<12 and/or urinary retention Written informed consent Exclusion Criteria: Mild symptoms (IPSS <8) Severe atherosclerosis Severe tortuosity in the aortic bifurcation or internal iliac arteries Acontractile detrusor Neurogenic lower urinary tract dysfunction Urethral stenosis Bladder diverticulum Bladder stone with surgical indication Allergy to intravenous contrast media Contraindication for MRI imaging Preinterventionally proven adenocarcinoma of the prostate Renal failure (GFR<60ml/min)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostatic artery embolization<br>Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure with rapid recovery and low morbidity | Procedure: Prostatic artery embolization<br> <br> |
| Other: Conventional monopolar transurethral prostatectomy<br>Standard treatment | Procedure: monopolar transurethral prostatectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the International Prostate Symptom Score |  | Baseline and 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of prostate volume using Magnetic Resonance Imaging |  | Baseline, 12 weeks and 24 months after intervention | 
| Changes in bladder diary | Changes in bladder diary (difference of voids during daytime and night-time, difference voided volume, difference liquid intake, difference incontinence episodes) | Baseline and at all follow up controls | 
| Pre- and postoperative changes in C-reactive Protein, Prostate-specific antigen (PSA), serum amyloid A, Interleukin-6 and Interleukin-10 |  | Baseline and 1 day, 2 days, 1 and 6 weeks post intervention | 
| Changes in urodynamic parameters |  | Baseline and 12 and 24 months after intervention | 
| Duration of hospitalization post procedure |  | hospital discharge | 
| Duration of post procedure catheterization |  | baseline and post intervention | 
| Changes in the CPSI and IIEF |  | baseline and at all follow-up controls after the intervention | 
| Procedure time and radiation parameters |  | after intervention | 
| Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size measured by TRUS and MRI |  | baseline | 
| Percentage of prostate tissue devascularized, based on contrast-enhanced MRI |  | 12 weeks and 24 months after intervention |