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Recruiting NCT07223580

A Study Of Corticosteroid On Postoperative Pain After Ureteroscopy For Urinary Calculi

Phase IV Interventional Ureteroscopy Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Corticosteroid, Placebo.
Who it may be relevant to
Registry conditions: Ureteroscopy, Post Operative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating The Role Of Corticosteroids In Post-Ureteroscopy Recovery For Urinary Calculi

Overview

The purpose of this research is to evaluate if corticosteroid (prednisone) after ureteroscopy and placement of the stent will help alleviate postoperative pain control in addition to other normal postoperative pain medications

Interventions

  • Drug Corticosteroid
    In addition to the standard of care postoperative ureteroscopy medication, participants will be given prednisone 25 mg orally, once a day for 5 days post-surgery.
  • Other Placebo
    In addition to the standard of care postoperative ureteroscopy medication, participants will be given a placebo pill orally, once a day for 5 days post-surgery.

Primary outcome measures

  • Change in Visual Analog Scale Pain Score [Time frame: Baseline, Day 1 (Post-operatively), Day 2, Day 3]
Secondary outcome measures (4)
  • Number of times non-opioid analgesics medication used [Time frame: 3 days]
  • Cumulative usage of non-opioid analgesics medication [Time frame: 3 days]
  • Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score [Time frame: Day 2 (Post-operatively), Day 3]
  • Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score [Time frame: Day 1 (Post-operatively), Day 2, Day 3]

Eligibility criteria

Inclusion criteria

  • Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen or pelvis) and who elect for definitive treatment via ureteroscopy with placement of ureteral stent.
  • Age 18 years or older
  • Patients of either gender
  • Patients of all ethnic backgrounds
  • Cable of giving informed consent
  • Capable and willing to fulfill the requirements of the study.

Exclusion criteria

  • History of chronic pain
  • Chronic use of opioids or other pain medication (>12 weeks)
  • Known allergies to corticosteroids.
  • Known or suspected pregnancy
  • Inability to give informed consent or unable to meet requirements of the study for any reason.
  • Bilateral ureteroscopy
  • Current Corticosteroid Use
  • Diabetic patients who are insulin dependent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Arizona — Scottsdale

Identifiers

NCT: NCT07223580 · 25-003416

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗