Stent Omission vs Placement for Kidney Stones

(ACCENT Trial)

Overseen By MUSIC Coordinating Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Ureteric injury, Anatomical abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

184 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy.

Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size left to the discretion of the surgeon. At the end of the procedure, the urologist will evaluate the ureter for iatrogenic injury, and the ureter will be graded using the Post Ureteroscopic Lesion Scale (PULS). Patients assessed with PULS 0 and PULS 1 will meet 2nd stage eligibility and will be randomized 1:1 to either stent omission or stent placement. When a stent is placed, the stent type and decision to leave a string (tether) will be at the operating urologist's discretion.

Hypothesis:

\- stent omission arm will be non-inferior to stent placement in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity, and have lower 30-day healthcare utilization.

Who Is on the Research Team?

Khurshid Ghani, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals planning to undergo a single procedure for unilateral kidney or ureteral stones, without significant ureteral injury. Participants must be able to complete surveys and adhere to study procedures throughout the duration of the study. They should have consented in writing and be pre-stented with an existing ureteral stent.

Inclusion Criteria

I have signed and dated the consent form.

My kidney stone is located in the ureter only.

I have kidney stones located only in my kidneys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopy and lithotripsy for stone disease, followed by randomization to stent omission or stent placement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of pain interference, pain intensity, urinary symptoms, and treatment satisfaction

4-6 weeks

Multiple assessments (in-person and virtual)

Extended Follow-up

Participants are monitored for healthcare utilization and stone-free rates

Up to 60 days

What Are the Treatments Tested in This Trial?

Interventions

• Access Sheath
• Stent

Trial Overview

The trial compares patient outcomes when omitting or placing a stent after using a Ureteral Access Sheath (UAS) during uncomplicated ureteroscopy. Patients will answer questionnaires about their pain and healthcare use post-surgery, with random assignment to either the stent omission group or the stent placement group.

How Is the Trial Designed?

Group I: Stent placement arm Experimental Treatment 1 Intervention

Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.

Group II: Stent omission arm Experimental Treatment 1 Intervention

Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+