Brief Summary
The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.
Brief Title
Optimal Stent Duration After Ureteroscopy
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.
Completion Date
Completion Date Type
Estimated
Conditions
Ureteral Stent
Eligibility Criteria
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)
* 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)
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06045962
Org Class
Other
Org Full Name
Mayo Clinic
Org Study Id
22-011586
Overall Status
Enrolling by invitation
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in Urinary Symptom Scores
Outcome Time Frame
Post-operative day 2-3 and 2-3 days after stent removal
Secondary Outcomes
Outcome Description
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)
Outcome Time Frame
Post-operative day 2-3 and 2-3 days after stent removal
Outcome Measure
Change in Pain Scores
Outcome Description
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.
Outcome Time Frame
Post-operative day 2-3 and 2-3 days after stent removal
Outcome Measure
Change in Quality of life
Outcome Description
Number of days participants return to work
Outcome Time Frame
30 days
Outcome Measure
Return to work
Outcome Description
Number of subjects to experience complications assessed by telephone, epic messages, ER visits related to procedure, unanticipated provider visits, and hospitalizations.
Outcome Time Frame
30 days
Outcome Measure
Complications
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dima Raskolnikov
Investigator Email
draskolnik@montefiore.org