Clinical trial NCT01928108: Fluid Intake Application to Reduce Kidney Stone Risks
Official title: Do Different Methods of Educating Patients Regarding Fluid Intake Reduce Kidney Stone Risks?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stone
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be Patients ≥ 18 years old, seen in urology or nephrology clinic with a diagnosis of kidney stone, and had a prior 24-hour urine result with volume less than 2 to 2.5 liters

Brief summary: The purpose of this investigation is to prospectively evaluate the benefit of different methods of educating patients regarding their fluid intake through a readily available daily cellular phone application to improve overall urine output and reduce risk factors for stone recurrence.

Detailed description: The prevalence of kidney stone disease in the United States is increasing. Recurrence of kidney stone disease has been reported as high as 50% at five years. Urine supersaturation is a predominant factor in the formation of crystallization and stone disease and is dependent on fluid volume. High fluid consumption that dilutes the urine has been shown both in vitro and in clinical studies to reduce the tendency for stone crystallization as well as effectively decrease stone recurrence. As a result, water intake greater than two liters per day is a common initial therapy for prevention of stone disease. However, studies have shown that despite physician counseling most patients are only able to modestly increase their urine volume through fluid intake. This finding may be due to a discrepancy in patient perception of their actual fluid intake and resulting urine volume. The purpose of this investigation is to prospectively evaluate the benefit of different methods of educating patient regarding their fluid intake through a readily available daily cellular phone application to improve overall urine output and reduce risk factors for stone recurrence.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 18 years old
2. Seen in urology or nephrology clinic at UNC with a diagnosis of kidney stone
3. Prior 24-hour urine result with volume less than 2 to 2.5 liters

Exclusion Criteria:

1. Patient without cellular phone capable of utilizing Android / Apple application
2. Patient already using some form of monitoring fluid intake / volume
3. Inability to take fluid by mouth
4. Patient with urinary diversion, chronic diarrhea, bowel diversion or other forms of excessive fluid loss
5. Inability to obtain informed consent
6. Non-English speaking

Primary outcomes:
measure: 24-hour urine volume
timeFrame: 7-10 days from baseline
Secondary outcomes:
measure: Actual 24-hour urine volume vs. patient perceived urine volume
timeFrame: 7-10 days from baseline
measure: Ease and interest in monitoring fluid intake based on survey data
timeFrame: 7-10 days from baseline
Other outcomes:
measure: 24-hour urine volume for study participants vs. urine volume for retrospective cohort of previously treated kidney stone patients
timeFrame: 7-10 days from baseline
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Memorial Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Davis Viprakasit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
citation: Preminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16.
citation: Pak CY, Sakhaee K, Crowther C, Brinkley L. Evidence justifying a high fluid intake in treatment of nephrolithiasis. Ann Intern Med. 1980 Jul;93(1):36-9. doi: 10.7326/0003-4819-93-1-36.
citation: Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A. Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study. J Urol. 1996 Mar;155(3):839-43.
citation: Parks JH, Goldfischer ER, Coe FL. Changes in urine volume accomplished by physicians treating nephrolithiasis. J Urol. 2003 Mar;169(3):863-6. doi: 10.1097/01.ju.0000044922.22478.32.