A Randomized, Double-blind, Placebo-controlled Study of Agropyron Repens, Mannitol and Magnesium Supplement for the Treatment of Calcium Oxalate Upper Urinary Tract Stones: The AMMOS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Stone volume
研究概览
简要总结
Following informed consent, all recruited patients will have a baseline non-contrast CT scan performed at the radiology department of "G. Gennimatas" hospital and reported by the same dedicated uroradiologist for evaluation of stone volume, location, and consistency. All patients will also have a free flow mid-stream urinalysis and culture before randomization.
The level of pain related to stones will be evaluated in all patients with the VAS tool completed before commencement of treatment and at the end of the study.
Patients with a DJ stent at study entry will also complete the mini-Ureteral Stent Symptoms Questionnaire (m-USSQ) and the PUF questionnaire completed one week into study, before commencement of treatment and at the end of the study after taking either RENALOF® or placebo. Patients with a DJ stent in situ at study entry, will have both ends of the DJ cut and send for culture during scheduled DJ stent change. Approximately 90 days after recruitment, all patients will have a follow up CT scan, done at "G. Gennimatas" hospital radiology department and evaluated by the same dedicated uroradiologist , and a mid-stream urinalysis and culture. Patients with a DJ in situ will have their catheters changed and cut ends from the distal and proximal stent coils of the removed DJ stents will be send for culture and sensitivity analysis. All patients will complete the VAS and the cohort of patients with DJ stents will complete both the mini-USSQ and PUF questionnaires.
During the study period patients will be instructed to report to the research team any cases of upper or lower urinary tract infection documented with a positive urine culture and any treatment related adverse events.
详细描述
A total of 82 patients with renal stone or ureteral stones measured on a CT scan performed no later than 1 month prior to randomization, will be recruited in the study. Full medical history as well as demographic data and relevant medical treatment will be recorded in all eligible patients, followed by a detailed physical examination.
All eligible patients who have read and signed the study consent form will be randomized to either RENALOF® or placebo.
The randomization sequence will be computer-generated by the study coordinating team. Randomization will be performed before enrolment of the first patient.
Both the investigators and the study participants will be blinded to the treatment received (RENALOF® or placebo). Following randomization, the participants will be given prefilled non-labelled boxes containing either active drug (RENALOF®) or placebo. The pills in all boxes will be visually identical in size, weight and shape. Each box will have a tag with a unique code. A list of all dispersed coded boxes and the type of drug each box contains (RENALOF® or placebo) will be kept sealed by the study coordinator until the end of the study. Only at the end of the study period the research team will be unblinded to the treatment each patient had received.
The study will be carried out in prespecified time-points, which are listed below:
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
- Double (Participant, Investigator)
盲法说明
Randomization sequence will be computer-generated by the study coordinating team
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years
- •Upper urinary tract stones
- •Stone density > 500 HU on CT (Mean Hounsfield Units of the largest stone)
- •Ability to understand and provide a written informed consent to participate in the study
排除标准
- •Staghorn stones occupying renal calyces and pelvis
- •Stone composition other than calcium, indirectly assessed or determined using the Hounsfield stone density units (a Mean Hounsfield score of < 500 units will be considered)
- •Use of other urinary urinary stone treatments
- •Use of magnesium supplementation
- •Chronic kidney disease (CKD) with eGFR<30 ml/sec
结局指标
主要结局
Stone volume
时间窗: 90 days
Stone volume (measured in mls) will be calculated using a dedicated software
次要结局
- Stent-related symptoms score in the cohort of patients with DJ stents.(90 days)
- Microbial growth of double J stents in the cohort of patients with DJ stents.(90 days)
- Overactive Bladder (OAB) Symptoms score(90 days)
- Pain level(90 days)
- Incidence of documented urinary tract infections(90 days)
研究者
Sountoulidis Petros
Assistant Professor
Aristotle University Of Thessaloniki