Access Sheath and Stent Trial (ACCENT)

Access Sheath and stENT 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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Stone; Ureteral Stone
• Intervention / Treatment: Other: Surveys

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MUSIC Coordinating Center; Phone Number: 734-232-4906; Email: esekulos@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Elaina Shoemaker; Phone Number: 734-232-4906; Email: esekulos@med.umich.edu
      • Principal Investigator: Kurshid Ghani, MS, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stent omission arm; Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.	Other: Surveys; Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.
Other: Stent placement arm; Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.	Other: Surveys; Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in PROMIS Pain Interference	This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The scores range from 6-30 with a higher score indicating greater interference.	Baseline (before procedure), 7-10 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in PROMIS Pain intensity	This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The scores range from 3-15 with a higher score indicating greater pain intensity.	7-10 days after procedure
Differences in PROMIS Pain intensity	This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The scores range from 3-15 with a higher score indicating greater pain intensity.	4-6 weeks after procedure
Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10	The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother).	7-10 days after procedure
Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10	The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother).	4-6 weeks after procedure
Difference in PROMIS Social Roles & Activities	This is one question from the PROMIS that participants select from Never (5) to Always (1) whether there is trouble doing all of participant's usual work. A lower score indicates more trouble.	Daily after procedure (10 days or up to stent removal)
Difference in Pain intensity assessment based on the Visual analog scale	Participants pain level is selected from 0-10 with a higher score indicating greater pain.	Daily after procedure (10 days or up to stent removal)
Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S)	This is a 6-item questionnaire that participants complete regarding the satisfaction with treatment. The range of scores for each question is between 0-5, with a range of score between 0-24 with a higher score indicating greater satisfaction.	7-10 days post procedure and 4 weeks
Count of days off work Patient		Day 7 post procedure and 4 weeks post procedure
Count of days off work Caregiver		Day 7 post procedure and 4 weeks post procedure
Composite healthcare utilization metric within 30 days (WinRatio)	WinRatio composite healthcare utilization score ranges from 1 to 6 based on each participants highest level of healthcare utilization, with higher score indicating a worse outcome: 6) Hospitalization and ICU care; 5) Unplanned hospitalization; 4) Additional OR or Interventional Radiology procedure 3) Emergency department visit; 2) Ambulatory encounter: clinic visit or diagnostic outpatient testing; 1) Ambulatory encounter: phone call or electronic medical record.	Up to 30 days after procedure
Abnormal imaging findings within 60 days	Urological imaging performed within 60 days per surgeon or patient preference.	within 60 days of procedure
Stone-free rates within 60 days	X-ray, Ultrasound, computerized tomography (CT) scan, or any combination	within 60 days of procedure
Differences in PROMIS Pain Interference	This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The scores range from 6-30 with a higher score indicating greater interference.	4-6 weeks after procedure

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Khurshid Ghani, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Surveys; Ureteral stent; Ureteroscopy and lithotripsy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Ureteral Diseases; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Ureterolithiasis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: HUM00264257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No