Optimal Stent Duration After Ureteroscopy

N/AEnrolling By InvitationNCT06045962

Mayo Clinic172 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

172

Conditions

Ureteral Stent

Interventions

Ureteral stentDEVICE

Used to open the ureter and help the kidney drain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (11)

Mayo Clinic Arizona

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of California San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Post-operative day 2-3 and 2-3 days after stent removal

Secondary Outcomes

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)

Time frame: Post-operative day 2-3 and 2-3 days after stent removal

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.

Time frame: Post-operative day 2-3 and 2-3 days after stent removal

Return to work

Number of days participants return to work

Time frame: 30 days

Complications

Number of subjects to experience complications assessed by telephone, epic messages, ER visits related to procedure, unanticipated provider visits, and hospitalizations.

Time frame: 30 days

Data from ClinicalTrials.gov

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