High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy

Kidney Stone Clinical Trial

Official title: Prospective, Randomized Study to Assess Patient Satisfaction and Stone Free Effect of High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine the differences in stone free results, patient side effects, and patient satisfaction between dusting vs. basket extraction for kidney and ureteral stones (a kidney stone located in the tube between the kidney and bladder) 6 mm and greater in size undergoing ureteroscopic treatment.

Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. Basket extraction is when a small wire basket is used to remove stone fragments.

Clinical Trial Description

On the day of surgery, the treatment assigned to the patient will be determined by chance, like flipping a coin. Neither the patient nor the study doctor will choose the treatment type. Each patient will have an equal chance of being given either surgical treatment. One group will have stones treated with high-powered laser dusting and the dust produced will pass spontaneously through the urine. The other group will have stones treated with low power laser fragmentation and stones will be removed using a basket. The surgical procedure will not differ from the treatment a patient would receive if he/she were not in this study.

After surgery, participants will complete a pain assessment questionnaire in the outpatient recovery area before being discharged to go home. Participants will also receive a daily email or text message to assess pain and daily activities. Participants will answer these questions daily until pain has resolved and daily activities have returned to baseline levels.

Six weeks after surgery, participants will undergo an ultrasound to assess for swelling of a kidney due to a build-up of urine (called hydronephrosis), which is standard of practice after ureteroscopy. Participants will also return to the urology clinic 12 weeks after surgery for a standard of care follow up visit. At this visit, participants will undergo standard of care procedures known as renal bladder ultrasound and kidney ureter bladder abdominal x-ray to evaluate for stones. Participants will also complete another pain assessment questionnaire at this appointment.

Researchers will review the medical record to evaluate the effectiveness of the surgery at removing kidney stones and preventing kidney stone recurrence as well as to track quality of life outcomes. ;

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Ureteral Calculi
• Ureteral Stone
• Ureterolithiasis

• NCT number: NCT05006937
• Study type: Interventional
• Source: Northwestern University
• Contact: Matthew Lee, MD
• Phone: 3126958146
• Email: matthew.lee@nm.org
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Completion date: December 31, 2024