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NOT YET RECRUITING
NCT07892599
NA

Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate

Sponsor: Ahmed Ebrahim Zahran

View on ClinicalTrials.gov

Summary

Holmium laser enucleation of the prostate (HoLEP) is an effective operation for men with urinary obstruction caused by a benign enlarged prostate. Some men leak urine for a period after the operation. Early apical release is a surgical step that frees the tip (apex) of the prostate at the start of the operation to reduce stretch on the urinary sphincter. The conventional technique cuts all the way around the apex, including the front (anterior) tissue next to the sphincter. This randomized trial compares a modified technique, Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR), with conventional early apical release during HoLEP. ABP-S-EAR leaves the front tissue bridge between the 11 and 1 o'clock positions intact. Men aged 45 to 80 years scheduled for HoLEP at Benha University Hospital, Egypt, will be randomly assigned to one technique. The main question is whether ABP-S-EAR improves urinary continence 1 month after surgery. The trial also compares continence at 3, 6, and 12 months, operative time, bleeding, catheter time, hospital stay, urinary symptoms, urine flow, and complications.

Official title: Anterior Bridge-Preserving Semi Circular Early Apical Release Versus Conventional Early Apical Release During HoLEP: A Prospective Randomized Comparative Study

Key Details

Gender

MALE

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2026-11-30

Completion Date

2029-04-30

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

PROCEDURE

Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR)

Bipolar Collins knife via 26 Fr continuous-flow resectoscope (120 W cut, 80 W coagulation) for apical and bladder neck incisions. Right incision from 6 o'clock proximal to the verumontanum to 11 o'clock; left from 6 to 1 o'clock. The 11 to 1 o'clock anterior bridge is preserved; dissection at its limits uses the blunt sheath tip without electrocautery. Paired longitudinal incisions from the bladder neck at 11 and 1 o'clock join the apical incisions. Retrograde holmium laser enucleation (550 µm fiber, 2.0 J, 40 Hz) leaves the bridge undisturbed, then mechanical morcellation. Conversion to conventional EAR is allowed if a safe capsular plane cannot be developed.

PROCEDURE

Conventional Early Apical Release (EAR)

Same bipolar Collins knife, resectoscope, laser and energy settings, and irrigation as the experimental arm. Continuous circumferential mucosal incision along the proximal border of the external sphincter, through 12 o'clock, completely dividing the anterior mucosal bridge. Retrograde holmium laser enucleation by the standard institutional technique, then intravesical morcellation.