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

Evaluating The Role Of Corticosteroids In Post-Ureteroscopy Recovery 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

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain; Ureteroscopy
• Intervention / Treatment: Drug: Corticosteroid; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rev V. Vilasan Shylaja; Phone Number: 480-574-1466

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Rev V. Vilasan Shylaja; Phone Number: 480-574-1466
      • Principal Investigator: Karen L. Stern, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of care plus Corticosteroid; Participants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg.	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 Names: Prednisone
Placebo Comparator: Standard of Care; Participants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale Pain Score	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.	Baseline, Day 1 (Post-operatively), Day 2, Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times non-opioid analgesics medication used	Total number of times participants used non-opioid analgesics medication	3 days
Cumulative usage of non-opioid analgesics medication	Total use of non-opioid analgesics medication of any kind, reported in mg	3 days
Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score	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.	Day 2 (Post-operatively), Day 3
Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score	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.	Day 1 (Post-operatively), Day 2, Day 3

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Karen L. Stern, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 30, 2025
• First Submitted That Met QC Criteria: October 30, 2025
• First Posted (Actual): November 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Prednisone; Adrenal Cortex Hormones
• Other Study ID Numbers: 25-003416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No