Optimal Stent Duration After Ureteroscopy

Mayo Clinic

Status: Invitation-only

Conditions: Ureteral Stent

Treatments: Device: Ureteral stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06045962

22-011586

Details and patient eligibility

About

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

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Uncomplicated Ureteroscopy and Stent Placement for 3-5 days

Active Comparator group

Description:

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

Treatment:

Device: Ureteral stent

Uncomplicated Ureteroscopy and Stent Placement for 7-9 days

Experimental group

Description:

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

Treatment:

Device: Ureteral stent