Actively Recruiting
Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
Led by Chinese PLA General Hospital · Updated on 2026-05-06
426
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety and effectiveness of thulium laser enucleation of the prostate combined with bladder neck incision in men with small-volume benign prostatic hyperplasia (BPH). Small-volume BPH may still cause significant bladder outlet obstruction and bothersome lower urinary tract symptoms, and the optimal surgical treatment for these patients remains uncertain. In this multicenter, randomized, single-blind, controlled trial, 426 eligible men aged 40 to 80 years will be assigned in a 1:1:1 ratio to one of three groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation alone, or transurethral resection of the prostate. The main goal is to compare the incidence of bladder neck contracture at 6 months after surgery. Other outcomes include symptom improvement, urinary flow, pain score, sexual function, and safety outcomes during follow-up.
CONDITIONS
Official Title
Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 40 to 80 years
- Diagnosis of benign prostatic hyperplasia and scheduled for surgical treatment
- International Prostate Symptom Score 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 less than 30 mL measured by transrectal ultrasound
- Ability to understand study requirements and complete treatment and follow-up
You will not qualify if you...
- Inability or refusal to provide informed consent or comply with follow-up
- Prostate-specific antigen level of 10 ng/mL or higher unless prostate cancer is excluded by biopsy
- Confirmed or suspected prostate or bladder cancer
- Pre-existing bladder neck contracture or urethral stricture before surgery
- Known coagulation disorder or abnormal coagulation function
- Neurogenic bladder or detrusor underactivity affecting bladder or sphincter function
- BPH complicated by acute urinary tract infection or prostatitis
- History of prostate surgery, urethral stricture, or neurogenic bladder
- History of prostate cancer or pelvic radiotherapy
- Severe cardiovascular, pulmonary, or systemic disease making surgery unsafe
- Participation in another BPH clinical trial within 3 months prior to enrollment
- Any other condition making participation unsuitable per investigator's judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
Research Team
Q
Qing Yuan, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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