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Optimization of Surgical Treatment Pathways for BPH Based on Real-World Data
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
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.
Official title: Optimization of Surgical Treatment Pathways for Benign Prostatic Hyperplasia Based on Real-World Data
Key Details
Gender
MALE
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2026-03-10
Completion Date
2026-09-07
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Conventional HoLEP Without Apical Pre-disconnection
Conventional en-bloc holmium laser enucleation of the prostate (HoLEP) is performed without apical pre-disconnection. After mucosal incision at the level of the verumontanum and bilateral exposure of the surgical capsule, the enlarged prostate tissue is enucleated along the capsule, released into the bladder, and morcellated for removal.
HoLEP With Fixed 12 O'clock Apical Pre-disconnection
En-bloc holmium laser enucleation of the prostate (HoLEP) is performed with standardized apical pre-disconnection before enucleation. The initial pre-disconnection is made at the fixed 12 o'clock position corresponding to the projection of the verumontanum onto the urethral mucosa, without adjustment based on MRI-derived sphincter anatomy. Enucleation and morcellation are then completed.
HoLEP With MRI-Guided Individualized Apical Pre-disconnection
En-bloc holmium laser enucleation of the prostate (HoLEP) is performed with apical pre-disconnection tailored to preoperative magnetic resonance imaging (MRI). MRI is used to assess the anatomical relationship between the 12 o'clock projection of the verumontanum (V point) and the endpoint of the external urethral sphincter (S point). For type A anatomy, pre-disconnection is performed at the V point. For type B anatomy, the pre-disconnection site is shifted 5 mm proximally toward the bladder neck. For type C anatomy, the proximal shift is individualized according to the MRI-measured distance between the V and S points. Enucleation and morcellation are then completed.
Locations (1)
The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital)
Nanjing, Jiangsu, China