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NCT Number: NCT07223580

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

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

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Key information

Conditions

Ureteroscopy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location status: Recruiting

Location contact

Karen L. Stern, MD

PRINCIPAL_INVESTIGATOR

Rev V. Vilasan Shylaja

CONTACT

480-574-1466

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Corticosteroid

Drug

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 names: Prednisone

Placebo

Other

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 outcomes

  1. Change in Visual Analog Scale Pain Score

    Time frame: Baseline, Day 1 (Post-operatively), Day 2, Day 3

    Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.

Secondary outcomes

  1. Number of times non-opioid analgesics medication used

    Time frame: 3 days

    Total number of times participants used non-opioid analgesics medication

  2. Cumulative usage of non-opioid analgesics medication

    Time frame: 3 days

    Total use of non-opioid analgesics medication of any kind, reported in mg

  3. Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score

    Time frame: Day 2 (Post-operatively), Day 3

    The Wisconsin Stone Quality of Life (WISQOL) questionnaire is a 29 item survey that assesses quality of life for participants with kidney stones and covers four domains: social impact, emotional impact, stone-related symptom impact, and vitality. Questions are answered on a 5-point Likert scale, (1 = Very true, 5 = Not at all true), with a total maximum score of 140. Higher scores indicate a better quality of life.

  4. Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score

    Time frame: Day 1 (Post-operatively), Day 2, Day 3

    The Canadian Endourology Group Stent Symptom Score (CEGSSS) is a 11-item questionnaire that assesses ureteral stent symptoms through three domains: urination, pain, and quality of life. Scoring is based on participant responses to the individual questions, with higher scores indicating a greater symptom burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Rev V. Vilasan Shylaja

CONTACT

480-574-1466

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 3, 2025
Registry last updated
Feb 3, 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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