Benign Prostatic HyperplasiaNCT07872085

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

A study testing Conventional HoLEP Without Apical Pre-disconnection, HoLEP With Fixed 12 O'clock Apical Pre-disconnection and HoLEP With MRI-Guided Individualized Apical Pre-disconnection in people with Benign Prostatic Hyperplasia and Stress Urinary Incontinence (SUI), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 85 years, men only
Conditions the study is for: Benign Prostatic Hyperplasia, Stress Urinary Incontinence (SUI)
What is being tested?: Conventional HoLEP Without Apical Pre-disconnection, HoLEP With Fixed 12 O'clock Apical Pre-disconnection and HoLEP With MRI-Guided Individualized Apical Pre-disconnection
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 1 siteChina
Study dates: 10 Mar 2026to 7 Sep 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 85 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: Optimization of Surgical Treatment Pathways for Benign Prostatic Hyperplasia Based on Real-World Data

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)
Being tested: Conventional HoLEP Without Apical Pre-disconnection, HoLEP With Fixed 12 O'clock Apical Pre-disconnection, HoLEP With MRI-Guided Individualized Apical Pre-disconnection
Medical subject headings: Prostatic Hyperplasia, Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conventional HoLEP Without Apical Pre-disconnectionProcedure or surgery
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-disconnectionProcedure or surgery
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-disconnectionProcedure or surgery
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.

Study groups in NCT07872085
Study group	Role	What they receive
Conventional HoLEP Without Apical Pre-disconnection	Active comparator	Not described Receives: Procedure: Conventional HoLEP Without Apical Pre-disconnection
HoLEP With Fixed 12 O'clock Apical Pre-disconnection	Active comparator	Not described Receives: Procedure: HoLEP With Fixed 12 O'clock Apical Pre-disconnection
HoLEP With MRI-Guided Individualized Apical Pre-disconnection	Experimental	Not described Receives: Procedure: HoLEP With MRI-Guided Individualized Apical Pre-disconnection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week, 1 month, and 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 20267 Sep 2026

First posted13 Oct 2026
Study start10 Mar 2026
Primary completion7 Sep 2026
Study completion7 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07872085
Sponsor's protocol ID: 2026-SR-163
Status last verified: Jan 2026
First submitted: 7 Oct 2026
Last updated: 13 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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