ThuLEP with or without bladder neck incision for small-volume BPH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares two surgical approaches for benign prostatic hyperplasia with small prostates (≤30 mL): ThuLEP alone versus ThuLEP plus transurethral bladder neck incision. The goal is to determine safety and effectiveness, focusing on postoperative outcomes such as bladder neck contracture and symptom/flow improvements. Eligible participants are men aged 50–85 with IPSS ≥8, Qmax ≤15 mL/s, and prostate volume ≤30 mL, and who are undergoing surgical treatment. The study leverages laser technology to minimize tissue injury while optimizing hemostasis and precision. Results should inform whether adding bladder neck incision provides meaningful benefits in this specific BPH subgroup.

Why it matters

Who can join: the full rules

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 critical conditions that preclude cooperation with the procedure and outcome evaluation.
* Psychiatric or neurological disorders preventing cooperation with the study.
* Participation in another clinical trial within 1 month prior to enrollment.
* Any other condition deemed inappropriate for inclusion by the investigators.

Where it's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yifeng Jing
• Email: jyf_123@163.com
• Phone: +86-13918839913

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.