Fluid Intake Application to Reduce Kidney Stone Risks

Kidney Stone Clinical Trial

Official title:

Do Different Methods of Educating Patients Regarding Fluid Intake Reduce Kidney Stone Risks?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928108
• Other study ID #: 13-2453
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: March 24, 2017
• Start date: July 2013
• Est. completion date: March 16, 2017

Study information

• Verified date: March 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 16, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Behavioral:
• iPhone Application
The iPhone application "waterlogged" will be used by participants using and iPhone cellular device. This application will be used to track daily fluid intake for 1 week.
• Android Application
The Android application "water my body" will be used by participants using an Android cellular device. This application will be used to track daily fluid intake for 1 week.

Locations

Country	Name	City	State
United States	North Carolina Memorial Hospital	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

Parks JH, Goldfischer ER, Coe FL. Changes in urine volume accomplished by physicians treating nephrolithiasis. J Urol. 2003 Mar;169(3):863-6. — View Citation

Preminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	24-hour urine volume for study participants vs. urine volume for retrospective cohort of previously treated kidney stone patients		7-10 days from baseline
Primary	24-hour urine volume		7-10 days from baseline
Secondary	Actual 24-hour urine volume vs. patient perceived urine volume		7-10 days from baseline
Secondary	Ease and interest in monitoring fluid intake based on survey data		7-10 days from baseline