NCT05443451已完成不适用
3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Adverse events (AE) and serious adverse events (SAE) related to the treatment
研究概览
简要总结
This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).
详细描述
This is a prospective, single centre, open-label and non-comparative trial planned on 12 patients. Patients who fit inclusion criteria would be recruited and offered microwave ablation to the enlarged prostate. The patients will be closely followed up to 6 months after treatment with serial assessment on safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age over 50 years.
- •Benign prostatic hyperplasia with prostate size 30-80 cc
- •IPSS ≥ 14
- •PSA ≤ 4 ng/mL or PSA >4 ng/mL with no evidence of suspicious lesion on mpMRI
- •Maximum urine flow rate (Qmax) ≤ 15 mL/s.
- •Post-Void Residual ≤ 150 mL.
- •Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation.
- •Informed written consent
排除标准
- •Significant intravesical median lobe hyperplasia.
- •Suspicious lesion on mpMRI prostate
- •History of prostate, bladder or urethral surgery.
- •History of prostate cancer
- •Presence of stones, bladder diverticulum and/or bladder tumor
- •History of long-term indwelling catheter.
- •Urethral stricture
- •Known coagulopathy or on anticoagulant
- •Presence of a pacemaker.
- •Active infection
- •Dysuria due to bladder dysfunction.
- •Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit.
- •Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).
- •Contraindications for mpMRI exam or MR contrast
- •Acute and/or chronic renal failure (GFR <50 ml/min and serum creatinine > 1.5 mg/d).
- •Patient currently participating in another interventional clinical trial.
研究组 & 干预措施
Transperineal Microwave needle ablation for symptomatic BPH
Experimental
干预措施: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH (Device)
结局指标
主要结局
Adverse events (AE) and serious adverse events (SAE) related to the treatment
时间窗: At 1 month
The severity of AE is grade by Clavien-Dindo classification.
次要结局
- Ablation treatment time(Intra-operation)
- Ease of the procedure measured with a score chosen by the operator(Post procedure immediately)
- Patient quality of life(Baseline, 1-week, 1-month, 3-month, and 6-month,)
- Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score(Baseline, 1 month, 3 months, 6 months)
- Change in urodynamic in uroflowmetry(Baseline, 1 month, 3 months, 6 months)
- Average patient post-operative pain level(Baseline, 2 and 4 hours after the procedure and at 1-week)
- Prostate volume change(Baseline, 3 months, 6 months)
- Urinary symptoms measured by International Prostate Symptom Score (IPSS) score(Baseline, 1 month, 3 months, 6 months)
- Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score(Baseline, 1 month, 3 months, 6 months)
- PSA change(Baseline, 3 months, 6 months)
- Patient satisfaction(Baseline, 1-week, 1-month, 3-month, and 6-month,)
- Length of hospital stay(The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure])
- Operation time(Intra-operation)
研究者
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong
研究点 (2)
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