← Back to all trials
Not Yet Recruiting
NCT07688447
Multicenter Randomized Controlled Trial of ThuLEP Versus ThuLEP Combined With Bladder Neck Incision in Patients With Small-Volume Benign Prostatic Hyperplasia
Conditions: Prostatic Hypertrophy, Benign
Sex: Male
Ages: 50 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Yifeng Jing
Location: Shanghai General Hospital Shanghai Shanghai Municipality
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07688447). StuddyBuddy aggregates publicly available trial information.