Optimal Stent Duration After Ureteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ureteral Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Uncomplicated Ureteroscopy and Stent Placement for 3-5 days

After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days

Group Type ACTIVE_COMPARATOR

Ureteral stent

Intervention Type DEVICE

Used to open the ureter and help the kidney drain

Uncomplicated Ureteroscopy and Stent Placement for 7-9 days

After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days

Group Type EXPERIMENTAL

Ureteral stent

Intervention Type DEVICE

Used to open the ureter and help the kidney drain

Interventions

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Ureteral stent

Used to open the ureter and help the kidney drain

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No