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

NCT07872085 | Completed

• 1 other identifier: 2026-SR-163
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia; Stress Urinary Incontinence (SUI)

Outcome Measures

Primary Outcomes (1)

• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) Total Score

  Urinary incontinence will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). The questionnaire measures the frequency and amount of urine leakage and its impact on daily life. The total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence and a greater impact on daily life. Total scores at 3 months after surgery will be compared among the three surgical groups.

  3 months after surgery

Secondary Outcomes (5)

• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) Total Score at Early Follow-up Visits

  1 week and 1 month after surgery

• International Prostate Symptom Score (IPSS) Quality of Life Score

  1 week, 1 month, and 3 months after surgery

• International Prostate Symptom Score (IPSS) Total Score

  1 week, 1 month, and 3 months after surgery

• Maximum Urinary Flow Rate (Qmax)

  1 week, 1 month, and 3 months after surgery

• Postvoid Residual Urine Volume (PVR)

  1 week, 1 month, and 3 months after surgery

Study Arms (3)

Conventional HoLEP Without Apical Pre-disconnection

ACTIVE COMPARATOR

Procedure: Conventional HoLEP Without Apical Pre-disconnection

HoLEP With Fixed 12 O'clock Apical Pre-disconnection

ACTIVE COMPARATOR

Procedure: HoLEP With Fixed 12 O'clock Apical Pre-disconnection

HoLEP With MRI-Guided Individualized Apical Pre-disconnection

EXPERIMENTAL

Procedure: HoLEP With MRI-Guided Individualized Apical Pre-disconnection

Interventions

Conventional HoLEP Without Apical Pre-disconnection PROCEDURE

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.

Conventional HoLEP Without Apical Pre-disconnection

HoLEP With Fixed 12 O'clock Apical Pre-disconnection PROCEDURE

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 Fixed 12 O'clock Apical Pre-disconnection

HoLEP With MRI-Guided Individualized Apical Pre-disconnection PROCEDURE

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.

HoLEP With MRI-Guided Individualized Apical Pre-disconnection

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 50 to 85 years.
• Diagnosed with benign prostatic hyperplasia and scheduled to undergo holmium laser enucleation of the prostate (HoLEP).
• International Prostate Symptom Score (IPSS) ≥8.
• Maximum urinary flow rate (Qmax) \<10 mL/s.
• Prostate volume ≥40 mL.
• Preoperative magnetic resonance imaging (MRI) available for anatomical assessment.
• Written informed consent provided before enrollment.

You may not qualify if:

• Neurogenic bladder.
• Urethral stricture.
• Pre-existing urinary incontinence.
• External urethral sphincter dysfunction.
• Active infection.
• Pelvic malignancy.
• Severe cognitive impairment.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 13, 2026
• Study Start: March 10, 2026
• Primary Completion: September 7, 2026
• Study Completion: September 7, 2026
• Last Updated: October 13, 2026

Record last verified: 2026-01

Locations

CN (1)