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Recruiting NCT07297953

Access Sheath and Stent Trial

No phase Interventional Kidney Stone Ureteral Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surveys.
Who it may be relevant to
Registry conditions: Kidney Stone, Ureteral Stone. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Access Sheath and stENT Trial

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Differences in PROMIS Pain Interference [Time frame: Baseline (before procedure), 7-10 days after procedure]
Secondary outcome measures (12)
  • Differences in PROMIS Pain intensity [Time frame: 7-10 days after procedure]
  • Differences in PROMIS Pain intensity [Time frame: 4-6 weeks after procedure]
  • 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]
  • 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]
  • Difference in PROMIS Social Roles & Activities [Time frame: Daily after procedure (10 days or up to stent removal)]
  • Difference in Pain intensity assessment based on the Visual analog scale [Time frame: Daily after procedure (10 days or up to stent removal)]
  • Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S) [Time frame: 7-10 days post procedure and 4 weeks]
  • Count of days off work Patient [Time frame: Day 7 post procedure and 4 weeks post procedure]
  • Count of days off work Caregiver [Time frame: Day 7 post procedure and 4 weeks post procedure]
  • Composite healthcare utilization metric within 30 days (WinRatio) [Time frame: Up to 30 days after procedure]
  • Abnormal imaging findings within 60 days [Time frame: within 60 days of procedure]
  • Stone-free rates within 60 days [Time frame: within 60 days of procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07297953 · HUM00264257

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗