With the increasing degree of population aging, the number of patients undergoing surgical treatment for benign prostatic hyperplasia (BPH) is steadily rising. Among them, patients with small-volume prostates (≤30 mL) represent a distinct clinical subgroup.
This population has several unique characteristics:
1. Approximately 17.5% of patients show suboptimal postoperative outcomes. 2. The incidence of postoperative bladder neck contracture (BNC) is relatively high, reaching up to 19.3% in some reports.
In addition, the pathophysiological mechanisms of small-volume BPH are different from those of larger prostates. These include increased fibrotic tension of the bladder neck and bladder neck elevation.
At present, there is no clearly established surgical approach specifically designed to further improve postoperative outcomes or effectively prevent bladder neck contracture in patients with small-volume BPH.
This study primarily compares the safety and efficacy of transurethral thulium laser enucleation of the prostate (ThuLEP) versus ThuLEP combined with bladder neck incision in the treatment of small-volume benign prostatic hyperplasia (BPH), with the aim of further optimizing surgical management strategies for small prostates and reducing the incidence of postoperative complications.
Male patients aged 50-85 years who meet the diagnostic criteria for benign prostatic hyperplasia (BPH), with a prostate volume ≤30 mL and requiring surgical intervention.
Preoperative International Prostate Symptom Score (IPSS) ≥8.
Preoperative maximum urinary flow rate (Qmax) ≤15 mL/s.
Bladder capacity ≥150 mL.
Patients with urethral stricture in whom passage of surgical instruments is not feasible.
Total PSA >10 ng/mL, or PSA between 4-10 ng/mL with a free-to-total PSA ratio <0.16, and confirmed malignancy on biopsy.
Coagulation disorders, including platelet count <80 × 10⁹/L.
Uncontrolled urinary tract infection.
Parallel
Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)
Procedure/SurgeryThis technique is one of the mainstream surgical interventions for BPH, with its safety and efficacy well established in numerous studies, and is considered a mature and well-standardized procedure.
ThuLEP combined with transurethral bladder neck incision
Procedure/SurgeryBladder neck incision is also a well-established surgical approach for BPH, similar to transurethral incision of the prostate (TUIP). In the experimental group of this study, after transurethral thulium laser enucleation of the prostate, a single incision was made at the 6 o'clock position of the bladder neck. The depth of the incision was consistent with that of TUIP. The incision was not extended, and no additional incisions were created, resulting in minimal injury to the bladder neck. Theoretically, this approach does not increase the risk of complications such as bleeding, urinary incontinence, urethral stricture, or bladder neck contracture, and it is supported by both sound anatomical rationale and clinical safety considerations.
Maximum flow rate (Qmax)
Based on similar clinical studies, the primary efficacy endpoint was defined as the maximum urinary flow rate (Qmax) at 6 months postoperatively. In patients with small-volume prostates, the underlying pathophysiological mechanisms commonly include bladder neck fibrosis, increased fibrotic 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 subgroup. In the experimental group, a combined surgical approach was applied. By performing a bladder neck incision, this technique may simultaneously address both prostatic tissue hyperplasia and bladder neck abnormalities in patients with small prostates who present with bladder neck stenosis, fibrosis, or anatomical alterations such as bladder neck elevation. Therefore, this combined approach may potentially lead to greater improvement in postoperative urinary flow parameters.
International prostate symptom score (IPSS)
The minimum value is 0, and maximum values 35. Higher scores mean a worse outcome.
Quality of life score(QoL)
The minimum value is 0, and maximum values 6. Higher scores mean a worse outcome.
Post-void residual urine volume (PVR)
Post-void residual urine volume is a key parameter for evaluating bladder emptying function, and in adult males it is generally considered to be less than 20 mL.
maximum flow rate (Qmax)
As mentioned in the previous part
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Shanghai General Hospital, China
Lead sponsor
Weifang Traditional Chinese Medicine Hospital
Collaborator
The People's Hospital of Dehong Autonomous Prefecture
Collaborator
Hunan Provincial People's Hospital
Collaborator
