Prevention of Urinary Stones With Hydration

Prevention of Urinary Stones With Hydration

Sponsors

Lead sponsor: Duke University

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source Duke University
Brief Summary

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.

Detailed Description

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.

Overall Status Recruiting
Start Date September 13, 2017
Completion Date September 1, 2021
Primary Completion Date September 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Stone passage observed and/or captured by the study participant. From Baseline through 24 months.
Procedural intervention for symptomatic stone From Baseline through 24 months.
Any procedural intervention for removal of asymptomatic renal or ureteral stone From Baseline through 24 months.
Secondary Outcome
Measure Time Frame
Asymptomatic formation of new stone detected by imaging From Baseline through 24 months.
Change in size of existing stone by ≥ 2 mm in any dimension detected by imaging From Baseline through 24 months.
Composite outcome: symptomatic stone recurrence, asymptomatic stone formation, increase of existing stone by ≥2 mm in any dimension detected by imaging From Baseline through 24 months.
24 hour urine total volume From Baseline through 24 months.
Costs of study interventions and treatments for USD during the follow‐up period Compared total between Baseline and the Month 24 visit.
Presence of lower urinary tract symptoms (Comprehensive Assessment of Self‐reported Urinary Symptoms) From Baseline through the Month 24 visit.
Enrollment 1642
Condition
Intervention

Intervention type: Behavioral

Intervention name: Fluid prescription

Description: The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.

Arm group label: Intervention

Intervention type: Behavioral

Intervention name: Financial incentive

Description: Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.

Arm group label: Intervention

Intervention type: Behavioral

Intervention name: Structured Problem Solving

Description: Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.

Arm group label: Intervention

Eligibility

Criteria:

Inclusion Criteria:

1. Aged ≥ 12 years

2. 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:

1. Stone passage

2. Procedural intervention

3. 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

3. Low 24‐hr urine volume

1. ≥18 years old: <1.8 L/day

2. <18 years old: <20 ml/Kg/day up to 1.8L/day

4. Able to provide informed consent (parental permission for children)

5. Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study‐provided wireless enabled "smart" bottle

Exclusion Criteria:

1. Spinal cord injury

2. 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.

3. Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease

1. Cystinuria

2. Primary hyperoxaluria

3. Primary xanthinuria

4. Primary hyperparathyroidism

5. Sarcoidosis

6. Medullary sponge kidney

4. History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo‐osmolality (serum osmolality <275 mosm/kg)

5. Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses

1. 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.

2. History of malabsorptive (e.g., Roux‐en‐Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures

3. 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

6. Women who are currently pregnant or planning pregnancy within 2 years.

7. Renal transplant recipient

8. Bedridden study participants (ECOG ≥ 3)

9. Uncorrected anatomical obstruction of the urinary tract

10. History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture)

11. Exclusions due to medication use:

1. Chronic use of lithium

2. Long‐term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)

3. Intake of narcotic medication on a daily basis for >30 days prior to enrollment

4. Supplemental Vitamin C (> 1 g daily)

12. 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.

13. 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:

1. Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide)

2. Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).

14. Study participants <2 yrs life expectancy

15. Non‐English Speakers

16. History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

17. Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney.

18. Psychiatric conditions impairing compliance with the study

19. Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol)

20. Individual who will be unable to participate in the protocol in the judgment of the investigator.

Gender: All

Minimum age: 12 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Charles Scales, MD, MSHS Principal Investigator Duke University
Overall Contact

Last name: Laura Johnson

Phone: 919-323-6831

Email: [email protected]

Location
facility status contact investigator
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting Angela Waits 507-538-2902 [email protected] John Lieske, MD Principal Investigator
Washington University, St. Louis | Saint Louis, Missouri, 63110, United States Recruiting Juanita Taylor 314-362-8045 [email protected] Henry Lai, MD Principal Investigator Alana Desai, MD Principal Investigator
Cleveland Clinic | Cleveland, Ohio, 44195, United States Recruiting Paige Gotwald 216-444-0124 [email protected] Sriharan Sivalingam, MD, MSc, FRCSC Principal Investigator
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting Emily Funsten 215-573-8070 [email protected] Peter Reese, MD, MSCE Principal Investigator
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19146, United States Recruiting Brittney Henderson 267-426-1337 [email protected] Gregory Tasian, MD, MSc, MSCE Principal Investigator
Children's Hospital | Dallas, Texas, 75390, United States Recruiting Martinez Hill 214-456-0279 [email protected] Naim Maalouf, MD Principal Investigator
University of Texas Southwestern | Dallas, Texas, 75390, United States Recruiting Joyce Obiaro 214-645-0322 [email protected] Naim Maalouf, MD Principal Investigator Linda Baker, MD Sub-Investigator
University of Washington | Seattle, Washington, 98195, United States Recruiting Holly Covert 206-616-5170 [email protected] Jonathan Harper, MD Principal Investigator Hunter Wessells, MD, FACS Principal Investigator
Location Countries

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Intervention

Arm group type: Experimental

Description: 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.

Arm group label: Control

Arm group type: No Intervention

Description: 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.

Acronym PUSH
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Investigator)

Masking description: The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.

Source: ClinicalTrials.gov