Prevention of Urinary Stones With Hydration

Status: Active, not recruiting
Location: See all (8) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: No
View:

• 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

Locations
United States
Minnesota
Mayo Clinic
Rochester
Missouri
Washington University, St. Louis
Saint Louis
Ohio
Cleveland Clinic
Cleveland
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
University of Pennsylvania
Philadelphia
Texas
Children's Hospital
Dallas
University of Texas Southwestern
Dallas
Washington
University of Washington
Seattle
Time Frame
Start Date: October 4, 2017
Estimated Completion Date: May 13, 2024
Participants
Target number of participants: 1658
Treatments
Experimental: 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.
No Intervention: 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.
Sponsors
Leads: Duke University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov

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