Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is a common urological disease in middle-aged and elderly men. With the acceleration of population aging in China, the incidence of BPH is continuously increasing. Domestic epidemiological data show that the prevalence of histological BPH is approximately 20% in men aged 50-60 years, 50% in those aged 61-70 years, 57.1% in those aged 71-80 years, and 83.3% in those aged 81-90 years. BPH leads to bladder outlet obstruction and changes in lower urinary tract symptoms, thereby significantly affecting patients' quality of life, and in advanced stages may result in bladder and renal dysfunction.

Transurethral resection of the prostate (TURP) has long been regarded as the "gold standard" for the surgical management of BPH by urologists. However, its application is limited by relatively high rates of postoperative complications, including bleeding, bladder neck contracture, urethral stricture, TUR syndrome, and a considerable reoperation rate. With the development and increasing application of laser technologies in urology, laser-based procedures have demonstrated growing advantages in the treatment of BPH.

Thulium (Tm) laser is a novel medical laser technology with a wavelength range of 1.75-2.22 μm. Thulium laser technology is characterized by simplicity of operation, minimal tissue injury, excellent hemostatic capability, and high precision. In recent years, it has developed rapidly and been widely adopted in urology. Transurethral thulium laser enucleation of the prostate is considered safe and efficient, with an easy learning curve, relatively short training period, and lower procedural cost, thus demonstrating broad clinical prospects.

The pathophysiology of bladder outlet obstruction in BPH can be divided into two major components: dynamic factors (increased smooth muscle tone of the prostate) and mechanical factors (urethral compression due to prostate enlargement) . Unlike large prostates (>80 mL), in most small-volume BPH cases, mechanical compression of the posterior urethra is not the predominant cause of obstruction. Some studies suggest that the main pathophysiological mechanisms in small prostates include bladder neck fibrosis, increased fibrous ring tension, and chronic prostatitis . In addition, bladder neck elevation and an increased prostatic urethral angle are also closely associated with lower urinary tract obstruction symptoms in this population.

Based on these considerations, we propose a combined surgical approach consisting of transurethral laser enucleation of the prostate combined with bladder neck longitudinal incision. By surgically incising the bladder neck, this technique may simultaneously address both prostatic hyperplasia and bladder neck abnormalities. For patients with small prostates accompanied by bladder neck stenosis, fibrosis, or anatomical abnormalities (such as bladder neck elevation), this combined procedure may effectively correct both tissue obstruction and bladder neck dysfunction in a single stage.