RecruitingNot Applicable

Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia

China120 participantsStarted 2026-07-01

Plain-language summary

With the increasing degree of population aging, the number of patients undergoing surgical treatment for benign prostatic hyperplasia (BPH) is steadily rising. Among them, patients with small-volume prostates (≤30 mL) represent a distinct clinical subgroup. This population has several unique characteristics: 1. Approximately 17.5% of patients show suboptimal postoperative outcomes. 2. The incidence of postoperative bladder neck contracture (BNC) is relatively high, reaching up to 19.3% in some reports. In addition, the pathophysiological mechanisms of small-volume BPH are different from those of larger prostates. These include increased fibrotic tension of the bladder neck and bladder neck elevation. At present, there is no clearly established surgical approach specifically designed to further improve postoperative outcomes or effectively prevent bladder neck contracture in patients with small-volume BPH. This study primarily compares the safety and efficacy of transurethral thulium laser enucleation of the prostate (ThuLEP) versus ThuLEP combined with bladder neck incision in the treatment of small-volume benign prostatic hyperplasia (BPH), with the aim of further optimizing surgical management strategies for small prostates and reducing the incidence of postoperative complications.

Who can participate

Age range

50 Years – 85 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 50-85 years who meet the diagnostic criteria for benign prostatic hyperplasia (BPH), with a prostate volume ≤30 mL and requiring surgical intervention. * Preoperative International Prostate Symptom Score (IPSS) ≥8. * Preoperative maximum urinary flow rate (Qmax) ≤15 mL/s. * Bladder capacity ≥150 mL. * Willing to participate in this clinical trial and has signed the informed consent form. * Able to communicate well with investigators and comply with the study protocol requirements. Exclusion Criteria: * Patients with urethral stricture in whom passage of surgical instruments is not feasible. * Total PSA \>10 ng/mL, or PSA between 4-10 ng/mL with a free-to-total PSA ratio \<0.16, and confirmed malignancy on biopsy. * Coagulation disorders, including platelet count \<80 × 10⁹/L. * Uncontrolled urinary tract infection. * Neurogenic bladder. * Presence of malignant tumors. * Urodynamic diagnosis of bladder neck sclerosis, detrusor underactivity, detrusor-sphincter dyssynergia, or unstable bladder. * Contraindications to surgery, such as severe cardiopulmonary disease. * Cognitive impairment, including senile dementia, cerebral atrophy, acute cerebrovascular disease, sequelae of cerebrovascular disease, or other conditions affecting cognitive function. * History of suprapubic cystostomy for benign prostatic hyperplasia. * Acute localized or systemic bacterial infection that has not been effectively controlled. * Presence of shock or other…

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.

1This trial compares two laser surgical procedures — ThuLEP alone versus ThuLEP combined with bladder neck incision — for small-volume enlarged prostates specifically; how would my doctor determine which of these approaches might be more appropriate for my prostate size and symptoms?
2Since the trial is not yet recruiting, how long might it be before I could even be considered for enrollment, and should I be thinking about established treatment options in the meantime?
3The primary outcome being measured is maximum urine flow rate (Qmax) — how does my current Qmax compare to what's considered clinically meaningful improvement, and what would that tell us about whether I'd benefit from either of these procedures?
4This trial is listed as Phase NA, which often applies to surgical procedure studies — what does that mean for what's already known about the safety and effectiveness of ThuLEP compared to standard surgical options for benign prostatic hyperplasia?
5Since this is a randomized trial, I wouldn't get to choose which procedure I receive — given my specific situation, is my doctor comfortable with me potentially being assigned to either arm, or is one approach already considered preferable for my case?

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

Maximum flow rate (Qmax)

Timeframe: The sixth month after the operation

Trial details

NCT IDNCT07688447

SponsorShanghai General Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Yifeng Jing

+86-13918839913 jyf_123@163.com

View on ClinicalTrials.gov More Prostatic Hypertrophy, Benign trials