NCT06793540招募中不适用
Effectiveness of Self-posturotherapy on the Elimination of Residual Fragments After Treatment of Lower Calyx Urinary Stones by Extracorporeal Lithotripsy or Retrograde Flexible Ureteroscopy.
GCS Ramsay Santé pour l'Enseignement et la Recherche4 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2025年6月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 4
- 主要终点
- stone free rate
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness of an auto posturotherapy technique on the RFS at three months of patients treated for lower calyceal urinary stones by extracorporeal lithotripsy (ECL) or retrograde flexible ureteroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pré Inclusion Criteria:
- •Patient having read and signed the consent form for participation in the study • Patient candidate for an intervention on a lower calyx stone <15mm by LEC or URSS
- •Patients meeting all of the following criteria may be definitively included in the study:
- •Patient treated by LEC, or patient treated by URSS and for whom the presence of lower calyceal fragments has been observed by endoscopy
- •Absence of JJ stent (patients for whom a JJ stent was implanted after URSS or before LEC may be included as soon as it is removed)
排除标准
- •Patients presenting one of the following criteria will not be included in the study:
- •Renal or ureteral malformation: ureteral stenosis, pyelo-ureteral junction syndrome, horseshoe kidney, para calyceal diverticulum, pelvic kidney.
- •LEC session interrupted due to treatment intolerance
- •Physical disability making posturotherapy impossible (particularly spinal, etc.), morbid obesity, major gastroesophageal reflux, heart or respiratory failure.
- •Balance disorder which would not allow self-posturotherapy to be carried out alone.
- •Patient under legal protection, under guardianship or under curatorship
- •Posturotherapy carried out while wearing a JJ probe
- •Posturotherapy carried out by a third party (physiotherapist or other)
- •Pregnant or breastfeeding patient
- •Patient not affiliated to the French social security system
- •Impossibility of providing the subject with informed information and/or giving written informed consent: dementia, psychosis, disorders of consciousness, non-French speaking patient
- •Treatment that may modify the clearance of fragments (beta blocker, diuretic, etc.)
- •Patient included in another therapeutic study protocol
结局指标
主要结局
stone free rate
时间窗: 3 month
次要结局
未报告次要终点
研究者
研究点 (4)
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