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NCT Number: NCT07297953

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.

Recruiting

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Diseases Ureteral Stone Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Elaina Shoemaker

CONTACT

[email protected]

734-232-4906

Kurshid Ghani, MS, FRCS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surveys

Other

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.

Primary outcomes

  1. Differences in PROMIS Pain Interference

    Time frame: Baseline (before procedure), 7-10 days after procedure

    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.

Secondary outcomes

  1. Differences in PROMIS Pain intensity

    Time frame: 7-10 days after procedure

    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.

  2. Differences in PROMIS Pain intensity

    Time frame: 4-6 weeks after procedure

    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.

  3. Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10

    Time frame: 7-10 days after procedure

    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. Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10

    Time frame: 4-6 weeks after procedure

    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).

  5. Difference in PROMIS Social Roles & Activities

    Time frame: Daily after procedure (10 days or up to stent removal)

    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.

  6. Difference in Pain intensity assessment based on the Visual analog scale

    Time frame: Daily after procedure (10 days or up to stent removal)

    Participants pain level is selected from 0-10 with a higher score indicating greater pain.

  7. Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S)

    Time frame: 7-10 days post procedure and 4 weeks

    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.

  8. Count of days off work Patient

    Time frame: Day 7 post procedure and 4 weeks post procedure

  9. Count of days off work Caregiver

    Time frame: Day 7 post procedure and 4 weeks post procedure

  10. Composite healthcare utilization metric within 30 days (WinRatio)

    Time frame: Up to 30 days after procedure

    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.

  11. Abnormal imaging findings within 60 days

    Time frame: within 60 days of procedure

    Urological imaging performed within 60 days per surgeon or patient preference.

  12. Stone-free rates within 60 days

    Time frame: within 60 days of procedure

    X-ray, Ultrasound, computerized tomography (CT) scan, or any combination

  13. Differences in PROMIS Pain Interference

    Time frame: 4-6 weeks after procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

MUSIC Coordinating Center

CONTACT

[email protected]

734-232-4906

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: ACCENT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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