What this study is
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
What's being tested
- Dexamethasone Sodium Phosphate Injection 20 mg
Intervention · DRUG
dexamethasone 20 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia
- Dexamethasone Sodium Phosphate Injection 4mg
Intervention · DRUG
dexamethasone 4 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia
Study details
- Official title
- Dexamethasone for Ureteral STent Symptoms (DUSTS): A Randomized, Double-blinded Controlled Study
- Sponsor
- The Methodist Hospital Research Institute
- Conditions
- Ureteral Stent-Related Symptom
- Enrolling
- 70 people
- Starts
- 2026-06-10
- Est. completion
- 2027-04
- Design
- Quadruple-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18-70 years old
- Patients who are undergoing unilateral retrograde ureteroscopy (semi-rigid or flexible) with planned ureteral stent placement for treatment of renal/ureteral stones
- Patients who can read and understand English
- Patients who can follow up post-operatively within 7 days at Houston Methodist Hospital
You can't join if
- Untreated UTI
- HbA1c ≥6.5 on preoperative testing
- Patients with prior diagnosis of any type of diabetes mellitus
- Patients with immunosuppression, including chronic corticosteroid use
- Patients with bleeding disorder
- Patients with chronic liver disease, cirrhosis, and liver failure.
- Patients taking strong CYP3A4 inducers or inhibitors within two weeks of screening
- Chronic opioid analgesic use
- Congenital renal abnormalities (e.g. pelvic kidney, ureteric duplication) that may impair stent placement
- Concurrent genitourinary malignancy
- Urinary diversion
- Renal transplantation
- History of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (e.g. endometriosis)
- Neurologic disorder (e.g. spinal cord injury, multiple sclerosis, spina bifida)
- Pregnant or breastfeeding
- Patients with cognitive impairments or untreated psychiatric illness
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHouston Methodist Hospital
Houston, Texas, United States
- Farida Tufail · Contact713-269-0186ftufail@houstonmethodist.org
- Monica Morgan, MD · Principal investigator
- Rose Khavari, MD · Sub-investigator
- Kathleen Kobashi, MD · Sub-investigator
Recruiting
Study team
Sponsor
The Methodist Hospital Research Institute
Study ID PRO00037902
Principal investigator
Monica Morgan, MD
The Methodist Hospital Research Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.