Ureteral Stent
Conditions
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.
Interventions
DEVICEUreteral stent
Used to open the ureter and help the kidney drain
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORKaren Stern, MD
Mayo Clinic
Outcome results
None listed