Transurethral Focal Laser Ablation Versus Transurethral Prostatectomy For Management Of Benign Prostatic Obstruction

NCT07196475 | Completed DMC

• 1 other identifier: FMASU MD 19/2022
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction and objectives: Laser prostatectomy has become an increasingly popular and effective alternative to transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH).-. This study focuses on assessing the safety, efficacy, and postoperative complications of Transurethral Focal Laser Ablation of Prostatic Adenoma (TU-FLAP) versus M-TURP in managing BPH, with a 12-month monitoring. Patients and Methods: 60 BPH cases meeting the inclusion criteria have randomly been assigned into 2 equal groups to undergo either TU-FLAP or M-TURP. Outcomes have been assessed using IPSS, QoL, Qmax, operative time, catheterization ,duration of hospital stay, PVR, PSA, and residual prostate volume. Safety was evaluated based on perioperative and postoperative complications.

Conditions

Benign Prostate Hypertrophy(BPH)

Outcome Measures

Primary Outcomes (1)

• Maximum urinary flow rate (Qmax) at 12 months

  Mean change in maximum urinary flow rate (mL/sec) measured by uroflowmetry compared to baseline.

  Baseline and 12 months

Secondary Outcomes (8)

• Change in International Prostate Symptom Score (IPSS) from baseline to 12 months

  1 year

• Operative time (minutes)

  1 year

• Length of hospital stay (days)

  Postoperative hospital stay

• Duration of catheterization (days)

  Postoperative period until catheter removal

• Post-void residual urine volume (PVR) at 12 months

  Baseline and 12 months

Interventions

FOCAL LASER ABLATION OF PROSTATE PROCEDURE

All monopolar TURP procedures were performed under spinal anaesthesia, whereas all TU-FLAP procedures were conducted under local anaesthesia with intravenous sedation. A single experienced surgical team performed all operations, with each surgeon having completed over 100 similar procedures prior to the study's initiation. Prophylactic antibiotic coverage with a third-generation cephalosporin has been administered at the time of anaesthesia induction. Cases were placed in the lithotomy position, followed by diagnostic urethrocystoscopy. In the TU-FLAP group, a 980 nm diode laser fig(1) by applying end-firing fiber fig(2) was introduced via the side working channel of a 22 Fr cystoscope under local anesthesia. Laser energy was applied at 15 watts for two minutes at multiple sites within the right and left prostatic lobes, approximately 1.5 cm distal to the bladder neck, with 1 cm spacing between punctures. In cases with an enlarged median lobe, one or two additional laser punctures were

Eligibility Criteria

• Gender Eligibility Details: Male participants only (self-identified
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lower urinary tract symptoms (voiding ± storage) refractory to medical treatment with IPSS \> 20 (International Prostate Symptom Score) and Qmax \< 15 mL/sec
• Refractory acute urinary retention
• Hematuria or recurrent urinary tract infections secondary to BPH
• Renal impairment secondary to prostatic obstruction

You may not qualify if:

• Proven malignancy by biopsy
• Urethral strictures
• Urinary bladder stones
• Previous prostate surgery
• Urodynamically proven neurogenic bladder
• Bladder cancer
• Unfit for anesthesia

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university _faculty of medicine

Cairo, Egypt

Location

Related Links

• https://sperlingprostatecenter.com/focal-laser-treatment-benign-prostatic-hyperplasia-bph/\>

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 29, 2025
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)