Optimal Stent Duration After Ureteroscopy

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

Detailed Description
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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.

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

Conditions
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Ureteral Stent

Intervention / Treatment
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* Device: Ureteral stent


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 |