Optimization of Surgical Treatment Pathways for BPH Based on Real-World Data

StatusCompleted
PhaseNot applicable
Started

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Record History

  1. Minor Study First Submitted
Benign prostatic hyperplasia is a noncancerous enlargement of the prostate that can cause difficulty urinating. Holmium laser enucleation of the prostate (HoLEP) uses a laser to remove prostate tissue blocking urine flow. Some patients experience stress urinary incontinence after surgery, meaning urine leakage during activities such as coughing, sneezing, or physical exertion. This may be related to temporary dysfunction or injury of the muscle that controls urine release. This single-center, prospective randomized study compares three HoLEP techniques in men aged 50-85 years with benign prostatic hyperplasia: conventional HoLEP without apical pre-disconnection; HoLEP with apical pre-disconnection at a fixed 12 o'clock location; and HoLEP with MRI-guided individualized apical pre-disconnection. Apical pre-disconnection involves separating the urethral lining near the tip of the prostate before the main tissue removal step. In the individualized group, preoperative magnetic resonance imaging (MRI) is used to tailor the separation site to each patient's anatomy. The study tests the hypothesis that MRI-guided individualized apical pre-disconnection reduces postoperative stress urinary incontinence and improves early urinary control and quality of life compared with the other two techniques, while maintaining the improvement in urination achieved by HoLEP. Participants are randomly assigned to one of the three surgical groups and assessed at 1 week, 1 month, and 3 months after surgery. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) total score at 3 months. This questionnaire measures the frequency and amount of urine leakage and its impact on daily life. Secondary outcomes include ICIQ-UI-SF scores at 1 week and 1 month, and quality of life, urinary symptoms, maximum urine flow rate, and postvoid residual urine volume at all three follow-up visits. Postoperative complications are also recorded and compared among groups.
Trial Details
NCT Number NCT07872085
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions
(from sponsor)
Benign Prostatic Hyperplasia, Stress Urinary Incontinence (SUI)
Related terms Prostatic Hyperplasia, Urinary Incontinence, Stress
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov