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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Yifeng Jing
jyf_123@163.com
+86-13918839913
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Control group
Patients in the control group will be treated with ThuLEP
Experimental: Intervention group
Patients in the intervention group will be treated with ThuLEP combined with transurethral bladder neck Incision
Sponsors
Collaborators: Hunan Provincial People's Hospital, The People's Hospital of Dehong Autonomous Prefecture, Weifang Traditional Chinese Medicine Hospital
Leads: Shanghai General Hospital, China

This content was sourced from clinicaltrials.gov