Prospective, Randomized, Controlled, Multicenter Trial of the Memokath® 044TW Thermo-Expandable Stent for Maintaining Urethral Patency in Patients After Dilation or Internal Urethrotomy of Recurrent Stricture of the Bulbar Urethra
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 14
- 主要终点
- Stent/control effectiveness - urethral patency
研究概览
简要总结
The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.
详细描述
Patients with bulbar urethral stricture are 2:1 randomised for either urethral dilation or internal urethrotomy with (treatment group) or without (control group) subsequent stenting. All patients are followed for up to one year at 4-6 weeks, 3, 6, 9 and 12 months with visual assessment (urethroscopy) of urethral patency at the treated segment of the urethra. The stent is removed at one year. In case of premature stent removal the patient is also followed for up to one year unless further intervention is decided.
Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males > 21 years of age
- •Recurrent stricture of the bulbar urethra:
- •< 50 mm in length on urethrography; and which
- •has a segment unable to accommodate a 16Fr flexible cystoscope
- •Healthy tissue on both sides of stent
- •Urinary flow in the abnormal range of the Siroky nomogram.
- •Written informed consent obtained prior to participation in the study
- •Patients must be available for all follow-up visits.
排除标准
- •Strictures:
- •outside the bulbous urethra
- •associated with, or suspected to be, urethral carcinoma
- •secondary to pelvic distraction injuries
- •Inability to enlarge the bulbar urethral stricture to > 26 Fr.
- •Presence of any other urologic implant
- •Presence of urethral diverticuli
- •History of hypospadias repair
- •Presence or prior history of balanitis xerotica obliterans.
- •Uncontrolled bleeding disorder
- •Active urinary tract infection
- •Any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (PSA); bladder malignancy; or any recurrent urinary stone formation.
- •Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease
- •Concurrent participation in another clinical investigation
- •Current illness that might confound the results of this investigation
- •Inability to participate in all of the necessary study activities
- •Inability or unwillingness to return for all required follow-up visits
- •Inability or unwillingness to sign the patient informed consent document
结局指标
主要结局
Stent/control effectiveness - urethral patency
时间窗: 1 year
次要结局
- Re-intervention(Short term)
- Standard survey instruments (QOL, IPSS etc.)(15 mos)
- Stent placement success(immediate)
- Peak urinary flow rate(Immediate)
- Stent removal success(immediate)