Prospective, non-randomized, controlled investigation of prostate (P) artery embolization (E) compared to holmium (Ho) laser enucleation of prostate for the treatment of symptomatic benign prostatic hyperplasia with prostate volume 80–250 cc: the hope trial outcome at 1 year
摘要
To compare outcomes of Prostate Artery Embolization (PAE) with Holmium Laser Enucleation of Prostate (HoLEP) for management of symptomatic benign prostate hyperplasia in men with prostate volume 80 to 250 cc.
MethodsIn this open-label prospective clinical-trial, 45 patients were enrolled in a 2:1 ratio to undergo PAE and HoLEP, respectively. The voiding parameter, sexual function, and complications were evaluated at 1, 3, 6, and 12-months. The primary endpoint was a reduction in the International Prostate Symptom Score (IPSS) at 3 months. Secondary-outcomes were change in the International Index of Erectile Function-15 (IIEF-15), International Consultation on Incontinence Questionnaire-urinary incontinence (ICIQ-UI), Quality-of-Life (QoL), IPSS, uroflow (Qmax) and Prostate Specific Antigen (PSA). Adverse-events were recorded and graded using the Clavien–Dindo Adverse-event (CD-AE) classification.
ResultsNo significant difference in median IPSS and quality of life improvement was observed at any follow-up point. PAE had significantly better IIEF-15 and ICIQ-UI outcomes than HoLEP at 1 and 3 months. HoLEP outperformed PAE in PSA reduction, Qmax, and post-void residual (PVR) improvement at 3 and 12-months. However, PAE had shorter hospital stays and avoided catheterization. No major adverse events (Clavien–Dindo ≥ grade 3) occurred in either group.
ConclusionIn men with BPH and prostate sizes 80–250gm, PAE and HoLEP produce similar IPSS and QoL improvement at medium-term follow-up. PAE had better IIEF-15 and ICIQ-UI, in addition to the advantage of avoiding catheterization and reduced hospital stay. HoLEP performed better in PSA reduction, Qmax, and PVR improvement at 3 and 12 months. No serious adverse events occurred in either treatment group. Small sample size and short-term follow-up were important limitations.