Benign Prostatic Hyperplasia
Conditions
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.
Interventions
PROCEDUREProstatic artery embolization
PROCEDUREmonopolar transurethral prostatectomy
Sponsors
Daniel Stephan Engeler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the International Prostate Symptom Score | Baseline and 12 weeks after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 hospitalization post procedure | hospital discharge | — |
| Changes of prostate volume using Magnetic Resonance Imaging | Baseline, 12 weeks and 24 months after intervention | — |
| Changes in urodynamic parameters | Baseline and 12 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 | — |
| Percentage of prostate tissue devascularized, based on contrast-enhanced MRI | 12 weeks and 24 months after intervention | — |
| 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 | — |
Countries
Switzerland
Outcome results
None listed