Thulium laser prostate enucleation with bladder neck incision for small prostate enlargement

Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia: A Multicentre, Randomized, Single-Blind, Controlled Trial

This trial will test whether adding a bladder neck incision to thulium laser enucleation helps men aged 40–80 with small-volume BPH reduce bladder neck contracture and improve urinary symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 426 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07569874 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, single-blind, parallel-controlled trial will enroll 426 men aged 40–80 with small-volume BPH and randomize them 1:1:1 to thulium laser enucleation plus bladder neck incision, thulium enucleation alone, or transurethral resection of the prostate (TURP). Small-volume BPH is defined as prostate volume under 30 mL with moderate-to-severe lower urinary tract symptoms or impaired voiding, and key inclusion criteria include IPSS ≥12 and maximum urinary flow ≤15 mL/s. The primary endpoint is the incidence of bladder neck contracture at 6 months after surgery, and secondary outcomes include symptom improvement, urinary flow, pain scores, sexual function, and safety during follow-up. The trial compares whether adding a bladder neck incision reduces postoperative contracture and improves clinical outcomes compared with enucleation alone or TURP.

Who should consider this trial

Good fit: Men aged 40–80 with symptomatic small-volume BPH (prostate volume <30 mL), bothersome LUTS (IPSS ≥12) and reduced urinary flow (Qmax ≤15 mL/s) who are scheduled for surgical treatment would be ideal candidates.

Not a fit: Men with larger prostates, known or suspected prostate or bladder cancer, pre-existing bladder neck contracture or urethral stricture, or those unable to comply with follow-up are unlikely to benefit from this specific approach.

Why it matters

Potential benefit: If successful, adding a bladder neck incision could lower the risk of postoperative bladder neck contracture and improve urinary symptoms after surgery for men with small prostates.

How similar studies have performed: Thulium enucleation and TURP are established surgical options for BPH, and small case series suggest bladder neck incision may reduce contracture in small prostates, but high-quality randomized evidence for this combined approach is limited.

Eligibility criteria

Inclusion Criteria:

* 1\. Male patients aged 40-80 years; 2. Diagnosis of benign prostatic hyperplasia and scheduled to undergo surgical treatment; 3. 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; 4. Prostate volume of less than 30 mL measured by transrectal ultrasound, calculated as length × width × height × 0.52; 5. 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:

* 1\. Inability or refusal to provide written informed consent, or inability to comply with the required follow-up schedule; 2. Prostate-specific antigen level of 10 ng/mL or higher, unless prostate cancer has been excluded by biopsy; 3. Confirmed or suspected prostate or bladder malignancy; 4. Pre-existing bladder neck contracture or urethral stricture before surgery; 5. Known coagulation disorder or abnormal coagulation function; 6. Neurogenic bladder or detrusor underactivity that may affect bladder or urethral sphincter function; 7. Benign prostatic hyperplasia complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis; 8. History of prostate surgery, urethral stricture, or neurogenic bladder; 9. History of prostate cancer or pelvic radiotherapy; 10. Severe cardiovascular disease, pulmonary disease, or other systemic disease that, in the investigator's judgment, would make the patient unable to tolerate surgery; 11. Participation in another clinical trial related to benign prostatic hyperplasia within 3 months before enrolment; 12. Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Qing Yuan, MD, PhD

Conditions: Benign Prostatic Hyperplasia, Bladder Outlet Obstruction, Lower Urinary Tract Symptoms, Small-Volume Benign Prostatic Hyperplasia, Thulium Laser Enucleation of the Prostate, Bladder Neck Incision, Bladder Neck Contracture