A new, multicenter trial has begun enrolling patients to evaluate the role of specific behavioral interventions to prevent the development, progression and recurrence of urinary stone disease (USD) in adults and children. This first-of-its kind, randomized clinical trial will extend over a two-year period.
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Cleveland Clinic is one of six academic centers across the U.S. participating in PUSH, which is sponsored by the National Institutes of Health (NIH). Sri Sivalingam, MD, principal investigator for Cleveland Clinic and Director of the Center for Endourology and Stone Disease at Cleveland Clinic Hillcrest Hospital, remarks that increased fluid intake has known therapeutic benefits in kidney stone disease.
“Fluid intake is essential to mitigate stone formation and prevent urinary stone disease [USD], however, patient compliance to this intervention is less understood. This trial aims to control compliance, measure outcomes and, ultimately, develop guidelines to standardize fluid intake protocols,” says Dr. Sivalingam.
Controls, interventions and remote monitoring through a “smart” water bottle
Both control and intervention groups will receive a “smart” water bottle that will monitor and record participants’ daily hydration status, a function that Dr. Sivalingam says will be important to build awareness and accountability of fluid intake. Financial incentives will also be used to motivate participants in both cohorts to meet their fluid intake goals.
Participants in the control arm of the study will receive standard care protocols for fluid intake with USD, and will be instructed to follow guidelines according to the American Urological Association.
The intervention arm will receive a personalized “fluid prescription,” which includes tailored recommendations by a health coach to support increased fluid intake, along with a structured problem-solving program to help patients overcome any potential barriers.
Enrollment is underway
This 24-month trial aims to enroll approximately 1,642 total participants, and recruitment is already underway. Study groups will be segmented into adult versus adolescents and first-time versus recurrent stone patients. Eligibility requirements are as follows:
- Children age 12-17 and adults
- At least one symptomatic stone event within the last three years
- Low 24-hour urine volume
- Owns and is willing and able to use a smartphone or other device that is compatible with the smart water bottle
For more information about this trial, visit www.clevelandclinic.org/pushstudy.