Optimal Stent Duration After Ureteroscopy
- Conditions
- Ureteral Stent
- Interventions
- Device: Ureteral stent
- Registration Number
- NCT06045962
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 172
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Uncomplicated Ureteroscopy and Stent Placement for 3-5 days Ureteral stent After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days Uncomplicated Ureteroscopy and Stent Placement for 7-9 days Ureteral stent After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days
- Primary Outcome Measures
Name Time Method Change in Urinary Symptom Scores Post-operative day 2-3 and 2-3 days after stent removal 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.
- Secondary Outcome Measures
Name Time Method Change in Pain Scores Post-operative day 2-3 and 2-3 days after stent removal 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)
Change in Quality of life Post-operative day 2-3 and 2-3 days after stent removal 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.
Return to work 30 days Number of days participants return to work
Complications 30 days Number of subjects to experience complications assessed by telephone, epic messages, ER visits related to procedure, unanticipated provider visits, and hospitalizations.
Trial Locations
- Locations (11)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Montreal
🇨🇦Montréal, Quebec, Canada
Montefiore Medical Center
🇺🇸Bronx, New York, United States