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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-11

Study Completion Date

2022-07-16

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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prostatic artery embolization

Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure with rapid recovery and low morbidity

Group Type EXPERIMENTAL

Prostatic artery embolization

Intervention Type PROCEDURE

Conventional monopolar transurethral prostatectomy

Standard treatment

Group Type OTHER

monopolar transurethral prostatectomy

Intervention Type PROCEDURE

Interventions

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Prostatic artery embolization

Intervention Type PROCEDURE

monopolar transurethral prostatectomy

Intervention Type PROCEDURE

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)

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No