Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Kidney stones are hard, pebble-like masses that form inside the kidney. Some kidney stones travel to the bladder and can pass out of the body in urine. When kidney stones are too large to pass on their own, patients may need treatment to remove them. Doctors use three procedures to remove kidney stones:

  • In ureteroscopy, or URS, a small, flexible instrument passed through the urethra and up the ureter breaks up and removes the stones. The ureter is the tube between the kidney and bladder. URS doesn’t usually require a hospital stay.
  • In shock wave lithotripsy, or SWL, shock waves from a machine travel inside the body and break up the stones. SWL also doesn’t usually require a hospital stay.
  • In percutaneous nephrolithotomy, or PCNL, a scope inserted through a small cut in the skin removes the stones. PCNL usually requires a short hospital stay.

In this study, the research team is comparing how well these three procedures remove kidney stones in children and youth.

Who can this research help?

Results may help young patients, parents, and doctors when considering how to treat kidney stones.

What is the research team doing?

The research team is recruiting 1,290 patients ages 8–21 who are getting treatment for kidney stones at 1 of 23 healthcare systems across the United States. Patients in the study receive URS, SWL, or PCNL. The research team is comparing how well these treatments work to remove kidney stones.

The research team is using ultrasound to see if patients still have kidney stones six weeks after their procedure. The team is also looking to see if patients have any unexpected hospital stays, emergency room, or ER, visits, or repeat surgeries within three months after treatment. The team wants to know if the three procedures work differently for male versus female patients, or for patients of different ages.

Patients complete surveys about their experience 1, 3, 6, 9, and 12 weeks after treatment. The surveys ask about patients’ anxiety and sleep, their relationships with family and friends, urinary symptoms, and the degree to which pain interferes with their daily activities.

Youth who were treated for kidney stones, caregivers, and health insurers are helping to design and conduct the study.

Research methods at a glance

Design Elements Description
Design Observational: prospective cohort study
Population Patients ages 8–21 undergoing treatment for kidney stones at a medical facility in the Pediatric KIDney Stone (PKIDS) Care Improvement Network
Interventions/
Comparators
  • Ureteroscopy (URS)
  • Shock wave lithotripsy (SWL)
  • Percutaneous nephrolithotomy (PCNL
Outcomes

Primary: kidney stone clearance

Secondary: unplanned hospitalizations, ER visits, repeat surgeries, pain intensity, pain interference, anxiety, psychological stress, peer relationships, sleep disturbance, urinary symptoms.

Timeframe 6-week follow-up for primary outcome

Project Information

Gregory E. Tasian, MD, MSc
The Children's Hospital of Philadelphia
$4,183,067

Key Dates

36 months
August 2019
January 2024
2019

Study Registration Information

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PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: November 23, 2021