Prevention of Urinary Stones With Hydration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,658
- 试验地点
- 16
- 主要终点
- Number of Participants With a Symptomatic Stone Event
研究概览
简要总结
A randomized clinical trial to investigate the impact of increased fluid intake and increased urine output on the recurrence rate of urinary stone disease (USD) in adults and children. The primary aim of the trial is to determine whether a multi-component program of behavioral interventions to increase fluid intake will result in reduced risk of stone disease progression over a 2-year period.
详细描述
This is a two arm randomized controlled trial that incorporates pragmatic features, an adaptable intervention, patient choice, and remote monitoring of fluid intake through a "smart" water bottle. The study period is 24 months and will enroll approximately 1642 participants. Randomization will be stratified within a study site by age (adult vs. adolescent) and first time vs. recurrent stone former.
Intervention and control arm study participants will receive a smart water bottle that records daily fluid consumption, usual care including guideline-based recommendations of adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 12 years
- •At least 1 symptomatic stone event (passage or procedural intervention) within 3 years prior to enrollment or a symptomatic stone event within 5 years if the patient also has new stone formation detected on imaging during the last 5 years. Symptomatic stone defined as any of the following:
- •Stone passage
- •Procedural intervention
- •Radiographically or ultrasonographically confirmed stone with any of the following:
- •i. Gross hematuria ii. Renal colic or atypical abdominal pain attributed to the stone, as determined by a treating provider iii. A clinical pattern of intermittent symptoms consistent with intermittent obstruction at the ureteropelvic junction, as determined by a treating provider
- •Low 24-hr urine volume
- •≥18 years old: <2.0 L/day
- •<18 years old: <25 ml/Kg/day up to 2.0L/day
- •Able to provide informed consent (parental permission for children)
- •Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study-provided wireless enabled "smart" bottle
排除标准
- •Spinal cord injury
- •Currently undergoing active treatment for cancer except basal cell skin cancer, or patients with a history of cancer who completed their initial therapy <1 year before screening.
- •Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease
- •Primary hyperoxaluria
- •Primary xanthinuria
- •Primary hyperparathyroidism
- •Sarcoidosis
- •Medullary sponge kidney
- •History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo-osmolality (serum osmolality <275 mosm/kg)
- •Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses
- •History of or current Crohn's disease, ulcerative colitis, short gut syndrome (e.g. ileostomy, bowel bypass surgery to treat obesity, small bowel resection), chronic diarrhea, or GI tract ostomy.
- •History of malabsorptive (e.g., Roux-en-Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures
- •Congestive heart failure
- •i. NYHA class II or greater, and/or ii. Hospital admission in the past year for heart failure d. Lung disease with a home oxygen requirement e. Chronic kidney disease (eGFR <30 ml/min/1.7 m2 over a 3-month period) i. For adults (age ≥18), we will use the CKD-Epi equation which requires the measurement of serum creatinine only. ii. For children (age <18), we will use the bedside Schwartz (CKiD) formula. f. Nephrotic syndrome (>3.5 grams of protein per 24 hours) g. Cirrhosis with ascites
- •Women who are currently pregnant or planning pregnancy within 2 years.
- •Renal transplant recipient
- •Bedridden study participants (ECOG ≥ 3)
- •Uncorrected anatomical obstruction of the urinary tract
- •History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture)
- •Exclusions due to medication use:
- •Chronic use of lithium
- •Long-term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)
- •Intake of narcotic medication on a daily basis for >30 days prior to enrollment
- •Supplemental Vitamin C (> 1 g daily)
- •Individuals with stones that have developed after the initiation of medications that are strongly associated with USD such as carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide), high dose vitamin C (> 1 g daily), high dose calcium supplementation (> 1,200 mg daily) AND who have discontinued or plan to discontinue these medications.
- •Individuals with stones composed of medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir) AND who have discontinued or plan to discontinue these medications.
- •Note: Individuals who are on long-term medications that increase the risk of stone disease, who cannot stop these medications due to other chronic conditions (e.g., HIV) and who may reduce their risk for stone recurrence through increased fluid intake, will be eligible to participate in the trial. Examples of these medications include:
- •Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide)
- •Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).
- •Study participants <2 yrs life expectancy
- •Non-English Speakers
- •History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
- •Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney.
- •Psychiatric conditions impairing compliance with the study
- •Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol)
- •Individual who will be unable to participate in the protocol in the judgment of the investigator.
研究组 & 干预措施
Intervention
Participants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake.
干预措施: Fluid prescription (Behavioral)
Intervention
Participants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake.
干预措施: Financial incentive (Behavioral)
Intervention
Participants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake.
干预措施: Structured Problem Solving (Behavioral)
Control
Participants in the control arm will receive standard care instructions according to American Urological Association (AUA) guidelines to increase overall fluid consumption to achieve study-specified urine output. They will also receive a "smart" water bottle with capability to self-monitor their fluid intake.
结局指标
主要结局
Number of Participants With a Symptomatic Stone Event
时间窗: Baseline through approximately 24 months
Having a symptomatic stone event was defined as meeting any 1 of 2 criteria - stone passage or a procedural intervention for a stone (whether the stone was causing symptoms or not).
次要结局
- Number of Participants With Asymptomatic Formation of New Stone(Up to approximately 24 months)
- Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension(Baseline through approximately 24 months)
- Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension(Baseline through approximately 24 months)
- 24-hour Urine Total Volume(6, 12, 18, and 24 months)
- Costs of Study Interventions and Treatments for USD During the Follow-up Period(Baseline through approximately 24 months)
- Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS)(Baseline, 6, 12, 18, and 24 months)