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

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Prostatic artery embolization; Procedure: monopolar transurethral prostatectomy

• Registration Number: NCT02054013
• Lead Sponsor: Daniel Stephan Engeler

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Study Start: 2014-02-11
• Primary Completion: 2017-09-19
• Study Completion: 2022-07-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prostatic artery embolization	Prostatic artery embolization	Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure with rapid recovery and low morbidity
Conventional monopolar transurethral prostatectomy	monopolar transurethral prostatectomy	Standard treatment

Primary Outcome Measures

Name	Time	Method
Changes in the International Prostate Symptom Score	Baseline and 12 weeks after intervention

Secondary Outcome Measures

Name	Time	Method
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
Changes of prostate volume using Magnetic Resonance Imaging	Baseline, 12 weeks and 24 months after intervention
Duration of hospitalization post procedure	hospital discharge
Changes in bladder diary	Baseline and at all follow up controls	Changes in bladder diary (difference of voids during daytime and night-time, difference voided volume, difference liquid intake, difference incontinence episodes)
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
Percentage of prostate tissue devascularized, based on contrast-enhanced MRI	12 weeks and 24 months 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
Procedure time and radiation parameters	after intervention

Trial Locations

Locations (1)

Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, Switzerland