Clinical trial NCT06045962: Optimal Stent Duration After Ureteroscopy
Official title: Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ureteral Stent
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Urinary Symptom Scores
timeFrame: Post-operative day 2-3 and 2-3 days after stent removal
Secondary outcomes:
measure: Change in Pain Scores
timeFrame: Post-operative day 2-3 and 2-3 days after stent removal
measure: Change in Quality of life
timeFrame: Post-operative day 2-3 and 2-3 days after stent removal
measure: Return to work
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Montréal
country: Canada
facility: University of Montreal
state: Quebec
Study officials:
affiliation: Mayo Clinic
name: Karen Stern, MD
role: PRINCIPAL_INVESTIGATOR
References: