Comparing stent placement versus omission after kidney stone treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial evaluates patient-reported outcomes and healthcare utilization following ureteroscopy and lithotripsy for kidney stones, comparing outcomes between patients who receive a ureteral stent and those who do not. Participants will be randomized into two groups: one receiving standard stent placement and the other omitting the stent. Additionally, an observational cohort will allow for treatment decisions based on physician judgment while collecting patient feedback through surveys. The study aims to assess differences in pain levels and unplanned healthcare visits between the two approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)
* Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan
* Access to means of communication with the study team (email, text messaging, and/or telephone)
* Adequate independent cognitive function and English language proficiency to complete study surveys
* Written informed consent

Exclusion Criteria:

* Planned bilateral ureteroscopy
* Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney
* Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
* Anatomic or functional solitary kidney
* Planned secondary or staged ureteroscopy
* Planned use of ureteral access sheath
* Pregnancy
* Patients who use opiate medication daily for greater than 3 months to manage a painful condition

Second Stage Exclusion Criteria:

* ureteral perforation
* unanticipated anatomic abnormality
* greater than expected bleeding
* ureteral dilation greater than 12 French
* ureteral access sheath utilized
* failed ureteroscopy
* no or incomplete lithotripsy performed
* unable to complete case due to medical or anesthetic event.

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• UF Health Shands Hospital
  Gainesville, Florida, United States Recruiting
• Indiana University Department of Urology
  Indianapolis, Indiana, United States Recruiting
• University of Michigan Health System
  Ann Arbor, Michigan, United States Recruiting
• University of Michigan Health System
  Brighton, Michigan, United States Recruiting
• Cadillac Munson Hospital
  Cadillac, Michigan, United States Recruiting

Study contacts

• Principal investigator: Khurshid Ghani, MD — University of Michigan
• Study coordinator: Elaina Shoemaker
• Email: Esekulos@med.umich.edu
• Phone: 734-764-3916

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Improving kidney stone clearance after surgery with home exercises

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• Self-posturotherapy to clear leftover fragments after lower-pole kidney stone treatment

  This trial will test whether a simple home posturotherapy technique helps people treated with extracorporeal lithotripsy or flexible ureteroscopy for lower-pole kidney stones get rid of remaining fragments over three months.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.