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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
Condition(s) studied
Prostatic Hypertrophy, Benign
Investigational drug(s) / intervention(s)
Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP)ThuLEP combined with transurethral bladder neck incision
Transurethral Thulium Laser Enucleation of the Prostate (ThuLEP): This technique is one of the mainstream surgical interventions for BPH, with its safety and efficacy well established in numerous studies, and is considered a mature and well-standardized procedure.
ThuLEP combined with transurethral bladder neck incision: Bladder neck incision is also a well-established surgical approach for BPH, similar to transurethral incision of the prostate (TUIP). In the experimental group of this study, after transurethral thulium laser enucleation of the prostate, a single incision was made at the 6 o'clock position of the bladder neck. The depth of the incision was consistent with that of TUIP. The incision was not extended, and no additional incisions were created, resulting in minimal injury to the bladder neck. Theoretically, this approach does not increase the risk of complications such as bleeding, urinary incontinence, urethral stricture, or bladder neck contracture, and it is supported by both sound anatomical rationale and clinical safety considerations.
Study 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
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.
Primary outcome measure(s)
- Maximum flow rate (Qmax) — The sixth month after the operation
Based on similar clinical studies, the primary efficacy endpoint was defined as the maximum urinary flow rate (Qmax) at 6 months postoperatively. In patients with small-volume prostates, the underlying pathophysiological mechanisms commonly include bladder neck fibrosis, increased fibrotic ring tension, and chronic prostatitis. In addition, bladder neck elevation and an increased prostatic urethral angle are also closely associated with lower urinary tract obstruction symptoms in this subgroup.
In the experimental group, a combined surgical approach was applied. By performing a bladder neck incision, this technique may simultaneously address both prostatic tissue hyperplasia and bladder neck abnormalities in patients with small prostates who present with bladder neck stenosis, fibrosis, or anatomical alterations such as bladder neck elevation. Therefore, this combined approach may potentially lead to greater improvement in postoperative urinary flow parameters.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Shanghai General Hospital |
Shanghai |
Shanghai Municipality |
Recruiting |
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