Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percentage of patients who perceive their voiding condition improved or very improved
研究概览
简要总结
Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of the striated sphincter activity during voiding and characterizes the spinal cord injuries located under the protuberance. The standard treatment for DSSD is medical, either pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are unable to perform CISC and require alternative surgical techniques such as external sphincterotomy which is invasive, irreversible and with no adjustment period for the patient.
Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary stents provide a non-definitive treatment, especially for evolutionary pathologies, for patients refusing a destructive surgery (psychosocial impact), or for patients having not defined yet their therapeutic preference. The Allium company has developed the " Bulbar Urethral Stent " (BUS) system, which advantages are the possibility to perform the procedure under local anesthesia and to remove more easily the stent, with similar performances compared to the other devices. In order to quantify the interest of the BUS system, the investigators propose to perform a prospective study aimed at describing its technical and clinical results in terms of efficacy and safety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient aged more than 18 years old
- •Presenting detrusor striated sphincter dyssynergia in the opinion of the investigator, based on clinical data and proven urodynamically
- •Detrusor striated sphincter dyssynergia with identified neurological origin
- •With contraindication or failure of the conventional treatments
- •Accepting the principle of the prosthetic incontinentation
- •Having given his signed consent to participate in the study
- •Affiliated with a social security scheme or assimilated.
排除标准
- •Minor patient or protected adult according to the terms of the law
- •Presenting contraindications to local regional anaesthesia
- •Presenting contraindications or a previous failure to the treatment by prosthetic sphincterotomy
- •Unable to hold a penile sheath.
研究组 & 干预措施
Allium BUS
Temporary urethral stent
干预措施: Allium " Bulbar Urethral Stent " (BUS) system (Device)
结局指标
主要结局
Percentage of patients who perceive their voiding condition improved or very improved
时间窗: One month after the surgical intervention
The perception of voiding condition by the patient will be measured with a 5-point Likert Scale. The patient will have to define the voiding condition compared to the initial (pre-procedure), as: very worse, worse, non-changed, improved, or very improved
次要结局
- Number of stent removals performed without hemorrhage(12 months after the surgical intervention)
- Number of patients requesting a change in the voiding method, i.e. premature removal of the stent(Up to 12 months following the surgical intervention)
- Number of complications, i.e. symptomatic urinary tract infections, encrustations, stenosis and hematuria, need for re-intervention and removals of the stent(Up to 12 months after the surgical intervention)
- Number of stents correctly positioned(Immediately after the surgical intervention)
- Maximum detrusor pressure and maximum urethral closure pressure, measured during the urodynamic testing(At inclusion, 1 month, 3 months, 6 months and 12 months after the surgical intervention)
- QUALIVEEN short form score (approved in French)(At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention)
- Number of stent migrations(1 month, 3 months, 6 months and 12 months after the surgical intervention)
- Post-void residual volume measured by retrograde urinary urethrocystography(At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention)