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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-85
SponsorShanghai General Hospital, China

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)
  • ThuLEP combined with transurethral bladder neck incision

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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