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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Sponsor changed: Yifeng Jing to Shanghai General Hospital, China
    • Recruitment opened
    • Site details revised
    • Collaborators: 4 to 3
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07688447
Lead Sponsor Shanghai General Hospital, China
Collaborators: Weifang Traditional Chinese Medicine Hospital, The People's Hospital of Dehong Autonomous Prefecture, Hunan Provincial People's Hospital
Conditions
(from sponsor)
Prostatic Hypertrophy, Benign
Related terms Prostatic Hyperplasia
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov