Not Yet RecruitingNot Applicable

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

China932 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Bladder Neck Contracture

Timeframe: 6 months after surgery (180 ± 7 days)

Trial details

NCT IDNCT07569874

SponsorChinese PLA General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Qing Yuan, MD, PhD

+8618910980422 qyuanmd@outlook.com

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials