Access Sheath and Stent Trial (ACCENT)

University of Michigan

Status: Enrolling

Conditions: Kidney Stone; Ureteral Stone

Treatments: Other: Surveys

Study type: Interventional

Funder types: Other

Identifiers

NCT07297953

HUM00264257

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing ureteral stent (pre-stented)
• Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
• Renal stone defined as only renal location of stone(s)
• Ureteral stone defined as ureteral only location of stone(s)
• Ureteral and renal stone(s)
• No evidence of significant ureteral injury on intra-operative assessment (Post-Ureteroscopy Lesion Scale (PULS) Grade 0 or 1)
• Ability and willingness to complete and adhere to survey questions and responses throughout study duration.

Exclusion criteria

• Pregnancy
• Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
• Evidence of ureteral stricture
• Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
• Known planned secondary or staged procedure
• Indwelling nephrostomy tube
• Bilateral ureteroscopy

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Stent omission arm

Other group

Description:

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

Treatment:

Other: Surveys

Stent placement arm

Other group

Description:

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

Treatment:

Other: Surveys