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OpenTrials
Active, Not Recruiting

NCT Number: NCT06045962

Optimal Stent Duration After Ureteroscopy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ureteral Stent

Device

Used to open the ureter and help the kidney drain

Primary outcomes

  1. Change in Urinary Symptom Scores

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

    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.

Secondary outcomes

  1. Change in Pain Scores

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

    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)

  2. Change in Quality of life

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

    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.

  3. Return to work

    Time frame: 30 days

    Number of days participants return to work

  4. Complications

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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