Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia: A Multicentre, Randomized, Single-Blind, Four-Arm Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 932
- 试验地点
- 1
- 主要终点
- Incidence of Bladder Neck Contracture
研究概览
简要总结
This study will evaluate the safety and effectiveness of different surgical treatments for men with small-volume benign prostatic hyperplasia (BPH). Men with small-volume BPH may still have bothersome lower urinary tract symptoms and bladder outlet obstruction, and the best surgical treatment for this group remains uncertain.
In this multicentre, randomized, single-blind, four-arm controlled trial, 932 eligible men aged 40 to 80 years will be assigned in a 1:1:1:1 ratio to one of four groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP).
The main goal of the study is to compare the incidence of bladder neck contracture at 6 months after surgery. Secondary outcomes include safety outcomes and changes in urinary symptoms, urinary flow rate, pain score, and symptom response at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores. Additional exploratory long-term outcomes will also be assessed at 12 months after surgery.
详细描述
Benign prostatic hyperplasia (BPH) is a common condition in aging men and may lead to bladder outlet obstruction and lower urinary tract symptoms. In some patients, clinically significant obstruction and symptoms can occur even when prostate volume is relatively small. Small-volume BPH should not necessarily be regarded as a mild condition, because these patients may still experience bothersome symptoms, impaired urinary flow, increased post-void residual urine volume, and bladder outlet obstruction. In this subgroup, obstruction may be related not only to adenomatous enlargement, but also to an elevated, narrow, or fibrotic bladder neck. Surgical treatment of small-volume BPH remains challenging, and the optimal surgical approach has not been clearly established.
This study is a multicentre, randomized, single-blind, four-arm controlled clinical trial designed to evaluate the safety and efficacy of different surgical strategies for patients with small-volume BPH. Eligible male participants aged 40 to 80 years with a prostate volume of less than 30 mL and clinically significant lower urinary tract symptoms or impaired voiding function will be enrolled. A total of 932 participants will be randomly assigned in a 1:1:1:1 ratio to one of four treatment groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP).
The primary objective of the study is to compare the incidence of bladder neck contracture at 6 months after surgery among the treatment groups. Secondary outcomes include safety outcomes and changes in International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), Visual Analogue Scale (VAS) score, and IPSS response rate at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores, including the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Additional exploratory long-term outcomes will be assessed at 12 months after surgery, including delayed bladder neck contracture, maintenance of urinary function, late adverse events, and the need for reintervention.
The study is designed to provide high-quality evidence on the comparative safety and effectiveness of these four surgical approaches in men with small-volume BPH and to help define an optimal surgical strategy for this specific patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Due to the nature of the surgical interventions, operating surgeons and the surgical team cannot be blinded. Participants will not be actively informed of their treatment allocation whenever feasible. Postoperative outcome assessors and statisticians will remain blinded to treatment allocation whenever possible.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 40-80 years.
- •Diagnosis of benign prostatic hyperplasia (BPH) and scheduled to undergo surgical treatment.
- •International Prostate Symptom Score (IPSS) of at least 12, maximum urinary flow rate of no more than 15 mL/s, with a voided volume greater than 150 mL.
- •Prostate volume of less than 30 mL measured by transrectal ultrasound (TRUS), calculated as length × width × height × 0.
- •Ability, as assessed by the investigator, to understand the study requirements and complete the scheduled treatment, follow-up visits, and study-related assessments.
排除标准
- •Inability or refusal to provide written informed consent, or inability to comply with the required follow-up schedule.
- •Prostate-specific antigen (PSA) level of 10 ng/mL or higher, unless prostate cancer has been excluded by biopsy.
- •Confirmed or suspected prostate or bladder malignancy.
- •Pre-existing bladder neck contracture or urethral stricture before surgery.
- •Known coagulation disorder or abnormal coagulation function.
- •Neurogenic bladder or detrusor underactivity that may affect bladder or urethral sphincter function.
- •Benign prostatic hyperplasia (BPH) complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.
- •History of prostate surgery, urethral stricture, or neurogenic bladder.
- •History of prostate cancer or pelvic radiotherapy.
- •Severe cardiovascular disease, pulmonary disease, or other systemic disease that, in the investigator's judgment, would make the patient unable to tolerate surgery.
- •Participation in another clinical trial related to benign prostatic hyperplasia (BPH) within 3 months before enrolment.
- •Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.
研究组 & 干预措施
ThuLEP Combined With Bladder Neck Incision
Participants assigned to this arm will undergo thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.
干预措施: Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision (Procedure)
ThuLEP Alone
Participants assigned to this arm will undergo thulium laser enucleation of the prostate alone. The procedure will be performed transurethrally, and hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound.
干预措施: Thulium Laser Enucleation of the Prostate (Procedure)
Transurethral Resection of the Prostate
Participants assigned to this arm will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.
干预措施: Transurethral Resection of the Prostate (Procedure)
Transurethral Incision of the Prostate (TUIP)
Participants assigned to this arm will undergo transurethral incision of the prostate (TUIP) using standard endoscopic equipment. After endoscopic inspection of the urethra, prostatic urethra, bladder neck, and bladder, one or two longitudinal incisions will be made at the bladder neck and prostatic urethra according to prostate morphology and the degree of obstruction. The procedure aims to relieve bladder outlet obstruction without substantial prostatic tissue resection. The incision site and extent will be individualized based on intraoperative anatomy, with careful avoidance of injury to the ureteric orifices, urethral sphincter, and adjacent structures. Haemostasis will be performed when necessary.
干预措施: Transurethral Incision of the Prostate (Procedure)
结局指标
主要结局
Incidence of Bladder Neck Contracture
时间窗: 6 months after surgery (180 ± 7 days)
Bladder neck contracture will be assessed based on postoperative symptoms, changes in urinary flow, cystoscopic findings, and investigator judgment.
次要结局
- Incidence of Postoperative Retrograde Ejaculation(Up to 6 months after surgery)
- Incidence of Device-Related New-Onset Severe Urinary Retention(Up to 6 months after surgery)
- Incidence of Device-Related New-Onset Stress Urinary Incontinence(Up to 6 months after surgery)
- Incidence of Device-Related Bleeding Events Requiring Blood Transfusion(Up to 6 months after surgery)
- Incidence of Device-Related Urethral or Prostatic Capsule Rupture Requiring Surgical Intervention(Up to 6 months after surgery)
- IPSS Response Rate(3 months and 6 months after surgery)
- Change From Baseline in Maximum Urinary Flow Rate (Qmax)(3 months and 6 months after surgery)
- Change From Baseline in International Prostate Symptom Score (IPSS)(3 months and 6 months after surgery)
- Change From Baseline in Visual Analogue Scale (VAS) Score(3 months and 6 months after surgery)
研究者
Qing Yuan
Professor and Chief Physician
Chinese PLA General Hospital