Access Sheath and Stent Trial

NCT07297953 | Recruiting

• 1 other identifier: HUM00264257
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Stone; Ureteral Stone

Keywords

Ureteral stent; Ureteroscopy and lithotripsy; Surveys; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Differences in PROMIS Pain intensity

  7-10 days after procedure

• Differences in PROMIS 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

  7-10 days after procedure

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

  4-6 weeks after procedure

• Difference in PROMIS Social Roles & Activities

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

Study Arms (2)

Stent omission arm

OTHER

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

Other: Surveys

Stent placement arm

OTHER

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

Other: Surveys

Interventions

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.

Stent omission arm; Stent placement arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi; Ureterolithiasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Khurshid Ghani, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUSIC Coordinating Center

CONTACT

734-232-4906; esekulos@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be informed of the presence or absence of a stent immediately following participants surgery.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Urology

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)