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Dexamethasone for Ureteral STent Symptoms (DUSTS)

RecruitingPhase 1, Phase 2Ages 18 Years - 70 YearsAllThe Methodist Hospital Research Institute
NCT06930690 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Dexamethasone Sodium Phosphate Injection 20 mg
  • Dexamethasone Sodium Phosphate Injection 4mg
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Where

1 site
Houston Methodist Hospital
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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