Recruiting
Phase 1
Phase 2

Dexamethasone vs. Dexamethasone

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06930690

Conditions

Ureteral Stent-Related Symptom

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Dexamethasone Sodium Phosphate Injection 20 mg

Dexamethasone Sodium Phosphate Injection 4mg

Study Details

Brief summary:

The purpose of this study to learn if high-dose dexamethasone, a type of long-acting steroid, works to decrease urinary symptoms and pain after ureteroscopy and stent placement for kidney stones. The main question it aims to answer is:

1\) Does high-dose steroid change the quality of life score on day 2 after surgery

Researchers will compare high-dose of dexamethasone (20 mg) to a standard dose of dexamethasone (4 mg) to see if a higher dose of the drug will help with urinary symptoms and pain

Participants will:

1. randomly receive 20 mg or 4 mg of dexamethasone (20 mg) at the time of surgery
2. fill out a questionnaire day 1 and day 2 after surgery
3. fill out a medication diary for one week after surgery
4. visit the clinic on day 2 after surgery for checkup
5. visit the clinic on day 4-7 after surgery for check up

Conditions

Ureteral Stent-Related Symptom

Study ID

NCT06930690

Start date

Jun, 2026

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18-70 years old
2. Patients who are undergoing unilateral retrograde ureteroscopy (semi-rigid or flexible) with planned ureteral stent placement for treatment of renal/ureteral stones
3. Patients who can read and understand English
4. Patients who can follow up post-operatively within 7 days at Houston Methodist Hospital

Exclusion Criteria:

1. Untreated UTI
2. HbA1c ≥6.5 on preoperative testing
3. Patients with prior diagnosis of any type of diabetes mellitus
4. Patients with immunosuppression, including chronic corticosteroid use
5. Patients with bleeding disorder
6. Patients with chronic liver disease, cirrhosis, and liver failure.
7. Patients taking strong CYP3A4 inducers or inhibitors within two weeks of screening
8. Chronic opioid analgesic use
9. Congenital renal abnormalities (e.g. pelvic kidney, ureteric duplication) that may impair stent placement
10. Concurrent genitourinary malignancy
11. Urinary diversion
12. Renal transplantation
13. History of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (e.g. endometriosis)
14. Neurologic disorder (e.g. spinal cord injury, multiple sclerosis, spina bifida)
15. Pregnant or breastfeeding
16. Patients with cognitive impairments or untreated psychiatric illness

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Dexamethasone 20 mg

active comparator: Control Arm

Dexamethasone 4 mg

Interventions

Dexamethasone Sodium Phosphate Injection 20 mg

dexamethasone 20 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia

Dexamethasone Sodium Phosphate Injection 4mg

dexamethasone 4 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia

Primary outcome measure

  • Global Quality of Life Score of Ureteral Stent Symptom Questionnaire (USSQ) [ Time Frame: Day 2 after surgery ]

Central Contacts and Locations

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77005

Contacts

Principal Investigator:

Monica Morgan, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Ureteral Stent
  • Nephrolithiasis
  • Ureteral Stent Discomfort
  • Ureteral Stent-Related Symptom

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-05-29.