Clinical trial NCT05006937: High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stone
Ureteral Stone
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* undergoing ureteroscopic stone extraction
* Stone size 6mm stones or greater and the location to mid ureter or higher
* Willing to sign informed consent form
* Able to read, understand, and complete patient questionnaires, and pain questionnaires

Exclusion Criteria:

* \< 18 years of age
* Inability to provide informed consent
* Concomitant surgery (i.e. Percutaneous nephrolithotomy, Holmium laser enucleation of the prostate
* Solitary kidney
* Nephrocalcinosis
* Members of vulnerable patient populations
* Patients without access to a phone that can receive txt messages

Primary outcomes:
measure: Stone free rate: clinical
timeFrame: 6 weeks
measure: Stone free rate: imaging
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient quality of life- pain intensity
timeFrame: 12 weeks
measure: Patient quality of life- pain interference
timeFrame: 12 weeks
measure: Return to work
timeFrame: 12 weeks
measure: Daily activity level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Krambeck, MD
role: PRINCIPAL_INVESTIGATOR
References: