Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Ureteral stent
- Conditions
- Ureteral Stent
- Sponsor
- Mayo Clinic
- Enrollment
- 172
- Locations
- 22
- Primary Endpoint
- Change in Urinary Symptom Scores
- Status
- Active, not recruiting
- Last Updated
- 11 days ago
Overview
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.
Investigators
Karen L. Stern
Principal Investigator
Mayo Clinic
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)
Arms & Interventions
Uncomplicated Ureteroscopy and Stent Placement for 3-5 days
After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days
Intervention: Ureteral stent
Uncomplicated Ureteroscopy and Stent Placement for 7-9 days
After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days
Intervention: Ureteral stent
Outcomes
Primary Outcomes
Change in Urinary Symptom Scores
Time Frame: 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 Outcomes
- Change in Pain Scores(Post-operative day 2-3 and 2-3 days after stent removal)
- Change in Quality of life(Post-operative day 2-3 and 2-3 days after stent removal)
- Return to work(30 days)
- Complications(30 days)