Trial launches to learn how to prevent kidney stone recurrence

September 13, 2017 – The DCRI serves as the Scientific Data Research Center for the Urinary Stone Disease Research Network, whose researchers are conducting the study.

Researchers are recruiting participants for a two-year clinical trial to determine whether using a high-tech water bottle and encouraging people to drink more water, and therefore urinate, will reduce the recurrence of urinary stone disease, also known as kidney stones.

The trial, known as the Prevention of Urinary Stones with Hydration (PUSH) study, is being conducted as part of a five-year initiative by the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) to improve outcomes for patients with kidney stones.

The purpose of the initiative, the Urinary Stone Disease Research Network (USDRN), is to design and conduct clinical trials in adults and children who suffer from kidney stones. The DCRI serves as the network’s Scientific Data Research Center. Charles Scales, MD, and Hussein Al-Khalidi, PhD, serve as the research center’s principal investigators.

In addition to the data research center, the USDRN comprises clinical sites at the University of Pennsylvania, Children’s Hospital of Philadelphia, the University of Texas Southwestern Medical Center, the University of Washington at Seattle, and Washington University. Investigators at the DCRI and each clinical site will work collaboratively to plan, execute, and analyze USDRN studies.

Kidney stones are small, hard mineral deposits that form inside the kidneys and can cause kidney damage and excruciating pain. Kidney stones affect about 1 out of 11 Americans. The prevalence of kidney stones among Americans has nearly doubled in the last 15 years, and is increasing in both adults and children. According to the NIDDK, kidney stones cost an estimated $10 billion each year, making them the most expensive non-malignant urologic condition in the United States. A recent study estimates that the impact of obesity, diabetes and population rates will increase costs of kidney stones by $1.24 billion a year by 2030.

Kidney stones are a recurring condition for many patients. Data from the National Health and Nutrition Examination Survey show that 35 percent of participants had experienced two or more distinct episodes of urinary stones. Although the causes of kidney stone formation are relatively well understood, there has been little clinical emphasis on preventing recurrent kidney stones. Many physicians treat kidney stones as discrete events, rather than a chronic metabolic condition resulting in painful “stone attacks.”

“If we treated people with heart disease the way we treat patients with kidney stones, we would only be treating patients with chest pain or a heart attack,” Scales said. “We wouldn’t pay attention to risk factors like smoking or cholesterol. My hope is that through this research network, we can focus on stone prevention, and empower patients to make the necessary lifestyle changes to avoid recurrent kidney stones.”

PUSH will enroll 1,642 people, half in an intervention group and half in a control group. The study’s primary aim is to determine whether a program of financial incentives, receiving advice from a health coach, and using a smart water bottle called Hidrate Spark that monitors fluid consumption and connects to an app will result in reduced risk of USD recurrence over a two-year period.

Those in the intervention group will be asked to drink a specific quantity of fluids calculated based on each person’s urine output. They will also be given financial incentives if they achieve their fluid targets. They will also meet with a health coach who will help identify barriers to drinking more liquids, and help solve them. Study participants in both groups will receive the water bottles to monitor how much they drink and will be asked to try to achieve a goal of drinking enough to expel 2.5 liters of urine per day – about 10.5 cups.

“Urinary stones are painful and debilitating, and their treatment expensive. We hope that identifying the barriers to water intake, and helping people overcome those barriers individually, will be successful,” said Ziya Kirkali, MD, program director of urology clinical research and epidemiology, in NIDDK’s Division of Kidney, Urologic, and Hematologic Diseases. “If successful, the study could change management of kidney stones, and could result in healthcare systems incorporating problem solving and prevention strategies, perhaps using incentives to modify behavior in people with urinary stone disease.”

The study is supported by the NIDDK (DK110986).