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The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncomplicated Ureteroscopy and Stent Placement for 3-5 days | Active Comparator | After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days |
|
| Uncomplicated Ureteroscopy and Stent Placement for 7-9 days | Experimental | After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteral stent | Device | Used to open the ureter and help the kidney drain |
|
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Karen Stern, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| University of Arizona |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| University of California San Diego | San Diego | California | 92122 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21206 | United States |
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University | Nashville | Tennessee | 37203 | United States |
| University of British Columbia | Vancouver | British Columbia | V6T1K2 | Canada |
| University of Montreal | Montreal | Quebec | H3C3J7 | Canada |