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

NCT07223580 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-003416
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ureteroscopy; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of times non-opioid analgesics medication used

  3 days

• Cumulative usage of non-opioid analgesics medication

  3 days

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

  Day 2 (Post-operatively), Day 3

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

  Day 1 (Post-operatively), Day 2, Day 3

Study Arms (2)

Standard of care plus Corticosteroid

EXPERIMENTAL

Participants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg.

Drug: Corticosteroid

Standard of Care

PLACEBO COMPARATOR

Participants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill.

Other: Placebo

Interventions

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.

Also known as: Prednisone

Standard of care plus Corticosteroid

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Adrenal Cortex Hormones; Prednisone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Karen L. Stern, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rev V. Vilasan Shylaja

CONTACT

480-574-1466

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: November 3, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)