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

Recruiting now · Not applicable

Conditions studied: Prostatic Hypertrophy, Benign

In brief

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.

Key facts

Study ID

NCT07688447

Run by

Shanghai General Hospital, China

People needed

120

Starts

2026-07-01

Expected to finish

2027-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 50 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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