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

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Mayo Clinic

Status and phase

Enrolling
Phase 4

Conditions

Ureteroscopy
Post Operative Pain

Treatments

Drug: Corticosteroid
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07223580
25-003416

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups, including a placebo group

Standard of care plus Corticosteroid
Experimental group
Description:
Participants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg.
Treatment:
Drug: Corticosteroid
Standard of Care
Placebo Comparator group
Description:
Participants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Rev V. Vilasan Shylaja

Data sourced from clinicaltrials.gov

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