Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

University of Michigan

Status: Enrolling

Conditions: Stone, Kidney; Stone Ureter

Treatments: Device: Standard of care stent placement; Other: No stent placement; Other: Surveys

Study type: Interventional

Funder types: Other

Identifiers

NCT05866081

CER-2021C2-22856 (Other Grant/Funding Number)

HUM00234740

Details and patient eligibility

About

This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent.

Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission.

Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants.

The study team hypothesizes that:

• Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts.
• Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.

Full description

The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan.

As sites are activated the registration will be updated.

Enrollment: 792 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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792 participants in 3 patient groups

Randomized cohort- No stent placement

Other group

Description:

Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed. If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study. In randomization cohort, second stage eligibility 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.

Treatment:

Other: Surveys

Other: No stent placement

Randomized cohort- Stent placement

Experimental group

Description:

Participants that are eligible and consent for the randomization cohort trial will have a stent placed. If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study. In randomization cohort, second stage eligibility 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.

Treatment:

Other: Surveys

Device: Standard of care stent placement

Observational participants - not randomized

Other group

Description:

Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.

Treatment:

Other: Surveys