Transurethral Thermodilatation Versus Prostatic Urethral Lift for Moderate-to-Severe BPH: A Randomised Controlled Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in International Prostate Symptom Score (IPSS) at 3 Months
研究概览
简要总结
This clinical trial aims to determine whether Prolieve® (microwave with balloon dilation) is as effective as UroLift® (prostate implants) for treating moderate-to-severe lower urinary tract symptoms in men aged 50-80 with enlarged prostates (BPH) who have failed oral medications.
The main questions are:
- Is Prolieve non-inferior to UroLift in improving IPSS symptom scores at 3 months?
- Does Prolieve cause less pain and avoid the need for injected anaesthesia?
Researchers will compare Prolieve (LA urethral gel only, no injections) against UroLift (LA urethral gel with or without local anaesthetic injection) to see if Prolieve offers similar relief with better tolerability.
Participants will stop their BPH medications for 2-4 weeks, undergo one of the two same-day office procedures, and attend follow-ups at 1, 3, 6, and 12 months for symptom scores, flow tests, and bladder scans.
详细描述
Clinical Context and Unmet Need Benign prostatic hyperplasia (BPH) is a common consequence of male ageing. In Hong Kong, over half of men in their 60s experience lower urinary tract symptoms (LUTS) that can significantly impair quality of life-disrupting sleep, limiting social activities, and causing bothersome urgency, frequency, and weak stream. As the local population continues to age, the absolute number of men requiring effective, low-risk procedural relief is set to rise substantially.
While traditional surgical options such as transurethral resection of the prostate (TURP) or laser enucleation (HoLEP) offer durable, highly effective outcomes, they mandate general or spinal anaesthesia, carry inherent risks of bleeding and transfusion, and frequently cause permanent retrograde ejaculation. These barriers exclude a significant portion of older men-particularly those on anticoagulants or with significant cardiovascular or respiratory comorbidities-from benefiting from procedural intervention.
This trial directly compares two contemporary minimally invasive surgical therapies (MISTs) that operate on fundamentally different biophysical principles:
UroLift® (Prostatic Urethral Lift - PUL) acts as a purely mechanical retraction device. Under cystoscopic visualisation, the operator deploys small, permanent nitinol (nickel-titanium) anchors to physically pull the obstructing prostatic lobes apart, widening the urethral channel. It does not ablate, resect, or thermally injure prostate tissue. Its effects are immediate and structural, relying on sustained mechanical traction.
Prolieve® (Transurethral Thermodilatation - TUTD) combines two synchronous therapeutic actions: (1) a 46 French (15.3 mm) balloon that mechanically dilates the prostatic urethra, and (2) simultaneous low-power microwave energy (up to 50 W) delivered via an intraurethral antenna, which gently heats the periurethral prostatic tissue to 41-46°C. This thermal dose induces controlled coagulation necrosis and protein denaturation. In the 4 to 12 weeks following the treatment, stromal remodelling results in a patent lumen. The balloon also serves to compress and flatten the obstructing tissue during heating, ensuring uniform energy delivery.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants must satisfy ALL of the following:
- •Male, aged ≥ 50 and ≤ 80 years
- •Moderate-to-severe LUTS due to BPH: IPSS total score ≥ 13 at screening
- •Peak urinary flow rate (Qmax) ≥ 5 and ≤ 12 mL/s with minimum voided volume ≥ 125 mL on free uroflowmetry. The lower Qmax bound of ≥ 5 mL/s excludes near-complete retention with likely detrusor underactivity, as adopted in the Rezūm pivotal trial
- •Prostate volume 30-80 g by transrectal ultrasound (TRUS) or multiparametric MRI, consistent with the L.I.F.T. and Rezūm pivotal study ranges
- •Post-void residual (PVR) ≤ 250 mL by bladder ultrasound
- •Currently on, or has previously tried, medical therapy for BPH (alpha-blocker and/or 5-alpha-reductase inhibitor) for ≥ 4 weeks with inadequate symptom control, or documented intolerance to medical therapy
- •Able to provide written informed consent
- •Able and willing to attend all study follow-up visits
排除标准
- •Participants will be excluded if ANY of the following apply:
- •Intravesical prostatic protrusion > 10 mm on TRUS.
- •Presence of metallic pelvic implants, penile prosthesis, femoral metallic implant, cardiac pacemaker, or implantable cardioverter-defibrillator.
- •Previous transurethral resection of the prostate (TURP), HoLEP, or any prior endoscopic prostate surgery.
- •Prior pelvic radiation therapy.
- •Prostatic urethral length < 1.2 cm or > 5.5 cm.
- •Confirmed or suspected prostate carcinoma (unresolved elevated PSA without negative biopsy, or any known malignancy).
- •Active urinary tract infection at screening.
- •Bladder stone, bladder tumour, or suspected bladder malignancy.
- •Urethral stricture or bladder neck contracture precluding catheter passage (Foley ≥ 18 Fr).
- •Neurogenic bladder or known clinically significant detrusor underactivity.
- •History of acute urinary retention.
- •Coagulopathy or therapeutic anticoagulation that cannot be bridged perioperatively.
- •Renal impairment: eGFR < 30 mL/min/1.73 m² (Cockcroft-Gault).
- •Desire to preserve fertility (due to risk of retrograde ejaculation with either device).
- •IPSS QoL bother score < 3 (patient not sufficiently bothered to warrant procedural intervention).
- •Participation in another interventional clinical trial within the preceding 30 days.
研究组 & 干预措施
Prolieve Transurethral Thermodilatation
Prolieve TUTD involves inserting a treatment catheter under intraurethral lidocaine gel only (no injected anaesthetic or sedation). A 46 French balloon dilates the prostatic urethra while microwave energy (≤50 W) heats periurethral tissue to 41-46°C for 45 minutes, combining mechanical dilatation with thermal ablation. Catheter removed immediately post-procedure; same-day discharge.
干预措施: Prolieve Transurethral Thermodilatation System (Device)
UroLift Prostatic Urethral Lift
UroLift PUL involves cystoscopic deployment of 4-6 permanent nitinol anchors to retract obstructing lateral prostatic lobes, mechanically widening the urethra without tissue ablation. Performed with topical intraurethral lidocaine gel, with or without periprostatic nerve block per site practice. No routine post-procedural catheterisation; same-day discharge.
干预措施: UroLift Prostatic Urethral Lift System (Device)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS) at 3 Months
时间窗: Baseline to 3 months post-procedure
Mean change in total IPSS score from baseline to 3 months post-procedure. IPSS ranges from 0-35 (higher = worse symptoms); negative change indicates improvement. Non-inferiority margin is 3 points. Analysis uses ANCOVA with treatment arm as fixed effect, adjusted for baseline IPSS, prostate volume stratum (\<40 vs ≥40 g), and baseline IPSS severity stratum (moderate 13-19 vs severe ≥20).
次要结局
- Change in IPSS total score at 6 months(Baseline to 6 months post-procedure)
- Change in IPSS Quality of Life Bother Score(Baseline to 3, 6, and 12 months post-procedure)
- Change in peak urinary flow rate (Qmax)(Baseline to 3, 6, and 12 months post-procedure)
- Change in post-void residual volume (PVR)(Baseline to 3, 6, and 12 months post-procedure)
- Change in erectile function (IIEF-5)(Baseline to 3, 6, and 12 months post-procedure)
- Antegrade ejaculation preservation rate(1, 3, 6, and 12 months post-procedure)
- Intra-procedural pain score(Index procedure (Day 0))
- Anaesthetic modality used(Index procedure (Day 0))
- Surgical retreatment rate(6 and 12 months post-procedure)
- Composite treatment success at 3 months(3 months post-procedure)
- Post-procedural catheterisation rate(Within 24 hours of index procedure)
- Rate of serious adverse events (Clavien-Dindo Grade ≥3)(30 days and 12 months post-procedure)
研究者
LEUNG SHUNG LAI JOHN
Clinical Assistant Professor
The University of Hong Kong