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

Starting soon · Not applicable

Conditions studied: Benign Prostatic Hyperplasia, Bladder Outlet Obstruction, Lower Urinary Tract Symptoms (LUTS)

In brief

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.

Key facts

Study ID

NCT07569874

Run by

Chinese PLA General Hospital

People needed

932

Starts

2026-07-01

Expected to finish

2028-12-01

Last updated by the study team

2026-07-21

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients aged 40-80 years.
• Diagnosis of benign prostatic hyperplasia (BPH) and scheduled to undergo surgical treatment.
• International Prostate Symptom Score (IPSS) of at least 12, maximum urinary flow rate of no more than 15 mL/s, with a voided volume greater than 150 mL.
• Prostate volume of less than 30 mL measured by transrectal ultrasound (TRUS), calculated as length × width × height × 0.52.
• Ability, as assessed by the investigator, to understand the study requirements and complete the scheduled treatment, follow-up visits, and study-related assessments.

You may not qualify if…

• Inability or refusal to provide written informed consent, or inability to comply with the required follow-up schedule.
• Prostate-specific antigen (PSA) level of 10 ng/mL or higher, unless prostate cancer has been excluded by biopsy.
• Confirmed or suspected prostate or bladder malignancy.
• Pre-existing bladder neck contracture or urethral stricture before surgery.
• Known coagulation disorder or abnormal coagulation function.
• Neurogenic bladder or detrusor underactivity that may affect bladder or urethral sphincter function.
• Benign prostatic hyperplasia (BPH) complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.
• History of prostate surgery, urethral stricture, or neurogenic bladder.
• History of prostate cancer or pelvic radiotherapy.
• Severe cardiovascular disease, pulmonary disease, or other systemic disease that, in the investigator's judgment, would make the patient unable to tolerate surgery.
• Participation in another clinical trial related to benign prostatic hyperplasia (BPH) within 3 months before enrolment.
• Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.

Where it is running

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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