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

Background. Transient stress urinary incontinence remains a common problem after HoLEP. Conventional early apical release (EAR) limits sphincter traction but uses a circumferential apical incision that divides the anterior peri-sphincteric tissue. The external urethral sphincter has anterior, lateral, and peri-prostatic relationships, which supports preserving an anterior tissue bridge during apical release.

Objective. To test whether Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR), which preserves the 11 to 1 o'clock anterior apical tissue bridge, improves early urinary continence compared with conventional EAR during HoLEP, without loss of surgical efficacy or safety.

Design. Prospective, randomized, controlled, parallel-group, single-center trial at the Urology Department, Benha University Hospital, Egypt. Recruitment of consecutive eligible men starts November 2026 and continues until the required sample size is reached.

Randomization and masking. Participants are randomized 1:1 using a computer-generated sequence with permuted blocks prepared before study start. Allocation is concealed in sequentially numbered, opaque, sealed envelopes prepared by an independent coordinator not involved in recruitment or outcome assessment. The envelope is opened in the operating room after induction of anesthesia and immediately before cystoscopy. The surgeon cannot be masked. Participants and independent outcome assessors (follow-up interviews, functional scoring, pad-weight testing) are masked to allocation.

Preoperative assessment. History, IPSS, IPSS-QoL (question 8), baseline continence status (daily pad count, leak history), PSA, complete blood count, serum creatinine, urinalysis (urine culture when indicated), uroflowmetry (Qmax), post-void residual by transabdominal ultrasound, and prostate volume and adenoma configuration by transrectal or transabdominal ultrasound.

Surgery. Spinal or general anesthesia, lithotomy position. Apical and bladder neck incisions are made with a bipolar Collins knife through a continuous-flow 26 Fr resectoscope (120 W cutting, 80 W coagulation). The bipolar working element is then exchanged for a laser working element in the same sheath, and enucleation is performed with a high-power holmium:YAG laser through a 550 µm end-firing fiber at 2.0 J and 40 Hz (80 W), with hemostasis at 1.0 J and 30 Hz. Irrigation height 60 cm H2O for enucleation and 80 to 100 cm H2O for morcellation. Energy settings, irrigation, and instruments are identical in both arms. All operations are performed by one experienced endourologist.

ABP-S-EAR arm. After cystoscopic inspection, a semicircular mucosal incision is made on the right from 6 o'clock (just proximal to the verumontanum) along the lateral mucosal groove to 11 o'clock, and on the left from 6 o'clock to 1 o'clock. The anterior apical tissue bridge between 11 and 1 o'clock is left intact. Dissection at the 11 and 1 o'clock limits uses the blunt tip of the resectoscope sheath without electrocautery, to avoid thermal injury to the anterior rhabdosphincter. Paired longitudinal incisions are made from the bladder neck at 11 and 1 o'clock down to the surgical capsule and joined to the apical incisions. The capsular plane is entered at the lateral apical releases and the lobes are mobilized retrogradely toward the bladder neck, leaving the bridge undisturbed. The lobes are detached at the bladder neck, pushed into the bladder, and removed with an intravesical mechanical morcellator. If a safe capsular plane cannot be developed, conversion to conventional EAR is allowed and the anatomical reason is recorded.

Conventional EAR arm. After cystoscopic inspection, a continuous circumferential mucosal incision is made with the same bipolar Collins knife along the proximal border of the external sphincter, through the 12 o'clock position, completely dividing the anterior mucosal bridge. Retrograde holmium laser enucleation follows by the standard institutional technique, then intravesical morcellation.

Postoperative care and follow-up. 22 Fr three-way Foley catheter with continuous saline irrigation, stopped when the effluent is clear. Trial without catheter per institutional protocol (usually postoperative day 1 or 2). Visits at 1, 3, 6, and 12 months. A standardized 1-hour pad test and questionnaires are done at 1 month. Qmax, PVR, IPSS, IPSS-QoL, pad use, and adverse events are recorded at every visit.

Outcomes. Primary: objective continence at 1 month (zero pads, no urge incontinence, 1-hour pad test weight gain of 1 g or less). Secondary: continence at 3, 6, and 12 months; operative, apical release, enucleation, and morcellation times; enucleation efficiency; hemoglobin decline; transfusion; catheter duration; hospital stay; changes in IPSS, IPSS-QoL, Qmax, and PVR to 12 months; bridge integrity; conversion rate; Clavien-Dindo complications.

Sample size. In a randomized trial of veil-sparing versus standard HoLEP, 23.1% of standard-arm patients had a positive 1-hour pad test at 1 month (continence 76.9%). An absolute increase of 15 percentage points (76.9% to 92%) is considered the minimum clinically important difference. With a two-sided chi-square test with continuity correction, alpha 0.05, and 80% power, 103 patients per arm are required; with 10% loss to follow-up, 115 per arm (230 in total).

Statistical analysis. SPSS (IBM). Normality by Shapiro-Wilk test and visual inspection. Continuous data as mean and SD or median and range; compared by independent t-test or Mann-Whitney U test. Categorical data as number and percentage; compared by chi-square or Fisher's exact test. The primary outcome is reported as proportions with the absolute difference and 95% confidence interval. Primary analysis by intention to treat (including conversions to conventional EAR), with a per-protocol sensitivity analysis. Two-sided tests, P \< 0.05 significant.

Ethics. Approval by the Research Ethics Committee, Faculty of Medicine, Benha University. Written informed consent from all participants.