ACTRN12609000760279招募中未知
Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra in males with benign prostatic hyperplasia: A Preliminary Investigation
eoTract, Inc.0 个研究点目标入组 70 人开始时间: 2009年9月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 55 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Diagnosis of lateral lobe symptomatic BPH
- •- IPSS Symptom score >13
- •- Peak urine flow rate> than 5ml/sec but
- •<12ml/sec on a voided volume > 125 ml
- •- Prostate volume >20 grams to <100
- •- American Society of Anesthesiologists
- •(ASA) risk group class I-III
- •- Normal microscopic urinalysis
- •- Stable prostate-specific antigen (PSA)
- •over two years, or agrees to undergo a
- •pre-treatment transrectal ultrasound and
- •prostate tissue biopsy, if clinically
- •indicated. Biopsy not required if
- •performed within 6 months of treatment
排除标准
- •- Mental capacity, dementia or inability to
- •give informed consent.
- •- Subject in retention, or with a previous
- •history of urinary retention.
- •- Post void residual volume >250 ml by
- •Ultrasound.
- •- Prostate gland with obstructive median
- •lobe or prominent bladder neck requiring
- •intervention.
- •- History of illness/symptoms or surgery
- •that may confound results of study, or
- •pose additional riskto subject.
- •- Patient with a life expectancy of less than
- •- Previous prostate surgery, dilation, stent,
- •laser, hyperthermia (ie non-
- •pharmaceutical prostate treatment).
- •- PSA > 10 ng/ml.
- •- Known, or suspected urological conditions
- •which may effect voiding function such
- •as confirmed or suspected malignancy
- •of the bladder or prostate, previous
- •pelvic irradiation or radical pelvic
- •surgery, neurogenic bladder and/or
- •sphincter abnormalities, cystolithiasis
- •or haematuria within 3 months,
- •urinarytract infection, urethral
- •strictures, bladder neck contracture,
- •active clinical prostatitis, bladder
- •pathologies or diabetes mellitus
- •affecting bladder function.
- •- Compromised renal function (serum
- •creatinine > 1.58 mg/l or > 0.1 mmol/L)
- •(ref: medcalc version 5.3 palm/os)
- •(medcalc.med-ia.net)
- •- Previous rectal surgery, other than
- •hemorrhoidectomy, that may have
- •distorted the pelvic anatomy, or any
- •implants in the pelvic/femoral
- •- Subject interested in future fertility.
- •- Concomitant medications: beta-blockers,
- •antihistaminics, anticonvulsants, and
- •antispasmodics within 1 week of
- •treatment unless there is documented
- •evidence that the subject has been on
- •the same drug dose for at least 6
- •months with a stable voiding pattern
- •(the drug dose should not be altered or
- •discontinued for entrance into or
- •throughout the study).
- •- Anti-coagulant medication other than
- 另有 20 项未显示
研究者
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