An interventional study of Conventional HoLEP Without Apical Pre-disconnection and HoLEP With Fixed 12 O'clock Apical Pre-disconnection in Benign Prostatic Hyperplasia and Stress Urinary Incontinence (SUI), sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to male participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 153 is above the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 563 studies on the registry; 311 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Procedure: Conventional HoLEP Without Apical Pre-disconnection
Procedure: HoLEP With Fixed 12 O'clock Apical Pre-disconnection
Procedure: HoLEP With MRI-Guided Individualized 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.
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.
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.
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.
Time frame: 3 months after surgery
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) Total Score at Early Follow-up Visits
Urinary incontinence will be assessed using the ICIQ-UI-SF, which 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. Scores will be compared among the three surgical groups at each follow-up visit.
Time frame: 1 week and 1 month after surgery
International Prostate Symptom Score (IPSS) Quality of Life Score
Quality of life related to urinary symptoms will be assessed using the single quality of life question accompanying the IPSS. Scores range from 0 (delighted) to 6 (terrible), with higher scores indicating worse quality of life related to urinary symptoms. Scores will be compared among the three surgical groups at each follow-up visit.
Time frame: 1 week, 1 month, and 3 months after surgery
International Prostate Symptom Score (IPSS) Total Score
Lower urinary tract symptom severity will be assessed using the seven symptom questions of the IPSS. The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms. Scores will be compared among the three surgical groups at each follow-up visit.
Time frame: 1 week, 1 month, and 3 months after surgery
Maximum Urinary Flow Rate (Qmax)
Maximum urinary flow rate will be measured by uroflowmetry and reported in milliliters per second (mL/s). Measurements will be compared among the three surgical groups at each follow-up visit to evaluate urinary flow after surgery.
Time frame: 1 week, 1 month, and 3 months after surgery
Postvoid Residual Urine Volume (PVR)
The volume of urine remaining in the bladder after urination will be measured and reported in milliliters (mL). Measurements will be compared among the three surgical groups at each follow-up visit to evaluate bladder emptying after surgery.
Time frame: 1 week, 1 month, and 3 months after surgery
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital with Nanjing Medical University →