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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Cantonal Hospital St. Gallen
Sankt Gallen, Switzerland
Changes in the International Prostate Symptom Score
Time frame: Baseline and 12 weeks after intervention
Changes of prostate volume using Magnetic Resonance Imaging
Time frame: 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)
Time frame: 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
Time frame: Baseline and 1 day, 2 days, 1 and 6 weeks post intervention
Changes in urodynamic parameters
Time frame: Baseline and 12 and 24 months after intervention
Duration of hospitalization post procedure
Time frame: hospital discharge
Duration of post procedure catheterization
Time frame: baseline and post intervention
Changes in the CPSI and IIEF
Time frame: baseline and at all follow-up controls after the intervention
Procedure time and radiation parameters
Time frame: 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
Time frame: baseline
Percentage of prostate tissue devascularized, based on contrast-enhanced MRI
Time frame: 12 weeks and 24 months after intervention
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