Optimal Stent Duration After Ureteroscopy

Ureteral Stent Clinical Trial

Official title:

Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06045962
• Other study ID #: 22-011586
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 172
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ureteral Stent

Intervention

Device:
• Ureteral stent
Used to open the ureter and help the kidney drain

Locations

Country	Name	City	State
Canada	University of Montreal	Montréal	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Vanderbilt University	Nashville	Tennessee
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic Minnesota	Rochester	Minnesota
United States	University of California San Diego	San Diego	California
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in Quality of life	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
Secondary	Return to work	Number of days participants return to work	30 days
Secondary	Complications	Number of subjects to experience complications assessed by telephone, epic messages, ER visits related to procedure, unanticipated provider visits, and hospitalizations.	30 days

External Links

•   Mayo Clinic Clinical Trials