NL-OMON40877撤回不适用
rodynamic effect of Prostate Artery Embolization for lower urinary tract symptoms due to benign prostate hyperplasia - UroPE study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male patients, > 40 years
- •- Lower urinary tract symptoms (LUTS) secondary to Benign Prostate Hyperplasia (BPH)
- •- Symptoms refractory tomedical therapy(*-adrenergic antagonist and 5*-reductase inhibitor for at least 6 months), or contraindication to medical therapy.
- •- Patient must be eligible candidate for Transurethral Resection of the Prostate (TURP)
- •- IPSS (International Prostate Symptom Score) >18 and QoL >3, or both
- •- BOR (Bladder Outlet Resistance) Schäfer grade *2
- •- PV (Prostate Volume) > 30 cm³.
- •- PVR (Post-Void Residual ) * 100 ml.
- •- Qmax ( maximum flow rate) * 15 ml/sec.
- •- Patient has given written Informed consent
排除标准
- •1. Active urinary tract infection or prostatitis
- •2. Suspicion of prostatic carcinoma during urologic work up for LUTS due to BPH.
- •3. Bladder atonia, acute urinary retention, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc),
- •4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- •5. Cystolithiasis or chronic hematuria within 3 months prior to study treatment
- •6. History of pelvic irradiation or radical pelvic surgery
- •7. Use of medication with negative effect on detrusor function.
- •8. Previous surgical procedures, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate or urethra.
- •9. Unable to undergo Magnetic Resonance Imaging
- •10. Allergy to iodinated contrast agents
- •11. Known upper tract renal disease or GFR * 59
- •12. Contraindications for angiography according to the UMC Utrecht standard of practice.
研究者
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