Optimal Stent Duration After Ureteroscopy

Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms

The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Ureteral Stent
• Intervention / Treatment: Device: Ureteral stent

Detailed Description

The rationale for this study is to determine if there is a difference in symptoms or complications among patients undergoing uncomplicated ureteroscopy for stone removal with shorter indwelling stent duration. Currently there are only a few small studies exploring the optimal duration of stent placement after stent placement and no multicenter randomized control trials. The investigation aim is to determine if earlier ureteral stent removal will reduce urinary symptoms after stent removal and improve quality of life without increasing risk of negative side effects. Using questionnaires for stent related symptoms the researchers will assess stent indwelling time effect on patient reported side effects.

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T1K2
      • University of British Columbia
  • Quebec
    • Montreal, Quebec, Canada, H3C3J7
      • University of Montreal
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
    • Tucson, Arizona, United States, 85712
      • University of Arizona
  • California
    • San Diego, California, United States, 92122
      • University of California San Diego
  • Maryland
    • Baltimore, Maryland, United States, 21206
      • Johns Hopkins University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota
  • New York
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

• Participants undergoing unilateral stone treatment. Patients may have stones present bilaterally, but must only be having unilateral intervention.
• The ureteroscopy must be uncomplicated
• Patients undergoing semi-rigid ureteroscopy only, flexible ureteroscopy only, or a combination

Exclusion Criteria

• Pregnancy
• A stent or nephrostomy tube placed prior to surgery
• Complex ureteroscopy - ureteral injury, ureteral perforation, ureteral stricture, impacted stone
• Infection or struvite stones
• Recurrent Urinary Tract Infection (UTI): 2 culture proven UTI in 6 months or 3 culture proven UTIs in one year
• No stone evident on ureteroscopic evaluation of ureter or kidney
• Transplant kidney
• Variant anatomy (horseshoe, pelvic kidney)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Uncomplicated Ureteroscopy and Stent Placement for 3-5 days; After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days	Device: Ureteral stent; Used to open the ureter and help the kidney drain
Experimental: Uncomplicated Ureteroscopy and Stent Placement for 7-9 days; After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days	Device: Ureteral stent; Used to open the ureter and help the kidney drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Urinary Symptom Scores	The urinary symptoms will be assessed using the self-reported Canadian Endourology Group Stent Symptom Score. Seven item questionnaire to assess urinary stent symptoms using a 5-point Likert scale; higher score indicated worse outcome.	Post-operative day 2-3 and 2-3 days after stent removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to work	Number of days participants return to work	30 days
Complications	Number of subjects to experience complications assessed by telephone, epic messages, ER visits related to procedure, unanticipated provider visits, and hospitalizations.	30 days
Change in Pain Scores	Pain score as indicated in the self-reported Canadian Endourology Group Stent Symptom Score questionnaire with a scale of 0-10 (10 being the worst)	Post-operative day 2-3 and 2-3 days after stent removal
Change in Quality of life	Change as calculated using the Wisconsin "Living With Kidney Stones" Questionnaire, which is a validated document assessing the quality of life of kidney stone patients. Likert scale 1-5 on 28 items total score range 28-140, with a lower score being associated with a lower quality of life.	Post-operative day 2-3 and 2-3 days after stent removal

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Karen Stern, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 22-011586

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: Yes
• product manufactured in and exported from the U.S.: No