Efficacy and Safety of Transurethral Columnar Balloon Dilation of the Prostate for the Treatment of Benign Prostatic Hyperplasia: A Multicenter Trial

Abstract

Objective. To observe the efficacy and safety of transurethral columnar balloon dilation of the prostate (TUCBDP) for benign prostatic hyperplasia (BPH) in a multicenter trial. Method. This multicenter study included 2050 patients with BPH who underwent TUCBDP from 11 cities of Zhejiang Province, from September 2015 to June 2021. Clinical assessment included recording and measurement of preoperative and postoperative data including prostate volume, serum prostate-specific antigen (PSA) levels, IPSS score, quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual urine (PVR), International Index of Erectile Function (IIEF-5), and Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF). Additionally, the correlation of the indicators was analyzed using linear regression and early postoperative complications were also recorded. Results. One month after surgery, the patients' IPSS score, QoL, and PVR were significantly decreased, while the Qmax, IIEF-5, and MSHQ-EjD-SF scores were increased considerably, compared with preoperative data. After surgery, the patient's IPSS score, QoL, and Qmax were improved year by year, while PVR gradually decreased. Three months after TUCBDP, IIEF-5 and MSHQ-EjD-SF levels reached the climax. Linear regression analysis showed that the serum PSA level was significantly positively correlated with Qmax at 3 months after TUCBDP, while at 6 months after surgery, it was negatively related to IPSS and QoL. Early postoperative complications appeared in 384 cases during follow-up. Conclusion. Collectively, TUCBDP may effectively improve the urinary and sexual function of BPH patients, with fewer postoperative complications, and its efficacy is not limited by age and prostate volume. It can be considered a better treatment option for BPH.