Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia

Summary

This study will evaluate the safety and effectiveness of different surgical treatments for men with small-volume benign prostatic hyperplasia (BPH). Men with small-volume BPH may still have bothersome lower urinary tract symptoms and bladder outlet obstruction, and the best surgical treatment for this group remains uncertain.

In this multicentre, randomized, single-blind, four-arm controlled trial, 932 eligible men aged 40 to 80 years will be assigned in a 1:1:1:1 ratio to one of four groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP).

The main goal of the study is to compare the incidence of bladder neck contracture at 6 months after surgery. Secondary outcomes include safety outcomes and changes in urinary symptoms, urinary flow rate, pain score, and symptom response at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores. Additional exploratory long-term outcomes will also be assessed at 12 months after surgery.

Conditions

• Benign Prostatic Hyperplasia
• Bladder Outlet Obstruction
• Lower Urinary Tract Symptoms (LUTS)

Interventions

PROCEDURE

Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision

Participants will undergo transurethral thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.

PROCEDURE

Thulium Laser Enucleation of the Prostate

Participants will undergo transurethral thulium laser enucleation of the prostate alone. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound. No bladder neck incision will be performed as part of the assigned intervention.

PROCEDURE

Transurethral Resection of the Prostate

Participants will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.

PROCEDURE

Transurethral Incision of the Prostate

Participants assigned to this intervention will undergo transurethral incision of the prostate using standard endoscopic equipment. One or two longitudinal incisions will be made at the bladder neck and prostatic urethra according to prostate morphology and the degree of obstruction. The procedure aims to relieve bladder outlet obstruction without substantial prostatic tissue resection. The incision site and extent will be individualized according to intraoperative anatomy, with careful avoidance of injury to the ureteric orifices, urethral sphincter, and adjacent structures. Haemostasis will be performed when necessary.

Sponsors & Collaborators

• Chinese PLA General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• China

Study Locations