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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006937
• Other study ID #: STU00214998
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Northwestern University
• Contact: Matthew Lee, MD
• Phone: 3126958146
• Email: matthew.lee[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Dusting
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
Basket extraction is when a small wire basket is used to remove stone fragments.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate: clinical	patients with no clinical evidence of kidney stones on the treated side	6 weeks
Primary	Stone free rate: imaging	patients with no radiographic evidence of kidney stones on the treated side	6 weeks
Secondary	Patient quality of life- pain intensity	patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Intensity - Short Form 3a. Higher score indicates higher pain levels. Lowest score 3, highest score 15.	12 weeks
Secondary	Patient quality of life- pain interference	patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Interference - Short Form 6b. Higher scores indicate higher levels of pain interference. Lowest score is 6, highest score is 30.	12 weeks
Secondary	Return to work	Days missed from work after surgery	12 weeks
Secondary	Daily activity level	Days until patients have returned to baseline pre-surgery daily activity level	12 weeks