Clinical Trials Directory

Trials / Completed

CompletedNCT02054013

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
101 (actual)
Sponsor
Daniel Stephan Engeler · Academic / Other
Sex
Male
Age
40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREProstatic artery embolization
PROCEDUREmonopolar transurethral prostatectomy

Timeline

Start date
2014-02-11
Primary completion
2017-09-19
Completion
2022-07-16
First posted
2014-02-04
Last updated
2022-12-07

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT02054013. Inclusion in this directory is not an endorsement.