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Dexamethasone for Ureteral STent Symptoms (DUSTS)

Dexamethasone for Ureteral STent Symptoms (DUSTS): A Randomized, Double-blinded Controlled Study

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06930690
Acronym
DUSTS
Enrollment
70
Registered
2025-04-16
Start date
2026-06-01
Completion date
2027-04-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stent-Related Symptom

Keywords

Ureteral Stent, Nephrolithiasis, Ureteral Stent Discomfort, Ureteral Stent-Related Symptom

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

Detailed description

Patient will be in the study for a duration of 30 days. Randomization will be performed on the day of surgery using the NIH Clinical Trial Randomization Tool. In the preoperative area, a finger stick blood glucose (FSBG) level will be checked. Patients with a FSBG ≥126 mg/dL will be disqualified from the study. Following induction of general anesthesia, the anesthesiologist will administer the study drug (dexamethasone 20 mg vs 4 mg) without members of the surgery team in the operating room. This is the only treatment that will be done for research purpose. The following are part of routine clinical care. Perioperative antibiotic prophylaxis will be given by the discretion of the surgeon following Houston Methodist Hospital (HMH) and American Urological Association (AUA) guidelines. Ureteroscopy (URS) will then be performed. If laser lithotripsy will be performed, a holmium or thulium laser will be used. After URS is completed, a ureteral stent will be placed. The length of the stent will be determined by the patient's height. Stent string can be left on or removed prior to placement based on surgeon discretion. Subjects will be prescribed tamsulosin (0.4 mg, #30), docusate (100 mg, #60), extended-release oxybutynin (10 mg, #30), and tramadol (50 mg, #20) OR acetaminophen/codeine (325/30 mg, #20). Stent removal will be performed in clinic 4-7 days after surgery. FSBG will be checked upon patient's arrival to the PACU. Postop corrective insulin lispro LOW dose will be administered if needed and FSBG will be rechecked in one hour according to Houston Methodist's "Diabetes and Hyperglycemia Management Postop" protocol. Persistent hyperglycemia will be defined as FSBG ≥200 one hour after insulin administration. If patient is experiencing persistent hyperglycemia, they will be admitted for monitoring. An endocrinologist will be consulted for evaluation and treatment of hyperglycemia and its acute complication if suspected. Patients will be observed in the PACU for at least 3 hours. After meeting standard discharge criteria, a final FSBG will be checked. Patients will only be discharged if FSBG is between 81 mg/dL and 200 mg/dL. For research purposes, the Ureteral Stent Symptom Questionnaire (USSQ) is a validated questionnaire that will be used to assess and measure ureteral stent symptoms in this study. One set of the USSQ will be given to patients as a packet after surgery, and patients will be instructed to take the questionnaire on POD 1. Subjects will be telephoned by study staff on POD1 to maximize the completion rate of forms and will be inquired if they have signs and symptoms of DKA/HHS (e.g. polyuria, polydipsia, fruity breath odor, nausea, vomiting, abdominal pain). Subjects will be instructed to seek care at the nearest emergency room if needed, preferably Houston Methodist Hospital. Subjects will also be given a medication diary to record the use of all medication prescribed following surgery. Opioid use will be converted to total morphine equivalents. Patients will also be instructed to follow up on POD2 in the clinic for a nursing visit and with the study coordinator. The second set of USSQ will be given and patients will fill out the questionnaire in the office. During this visit, a random FSBG will also be checked for research purpose. If FSBG ≥200 mg/dL, patients will be directed to seek care at the emergency room at Houston Methodist Hospital. An endocrinologist will be consulted for evaluation and treatment of hyperglycemia and its acute complication if suspected. Patient will come to the clinic again on POD4-7 for stent removal. Subjects will not fill out the USSQ questionnaire on these days. The medication diary will be collected from the subjects during this visit. A random FSBG will also be performed during this follow up visit for research purpose. If FSBG ≥200 mg/dL, patients will be directed to seek care at the emergency room at Houston Methodist Hospital. An endocrinologist will be consulted for evaluation and treatment of hyperglycemia and its acute complication if suspected. On the 30 day after their surgery, subjects will be telephone by study staff to record any adverse events including side effects, emergency room visits, or hospital admission. Their electronic medical records within the 30 days will also be reviewed by the study team.

Interventions

DRUGDexamethasone Sodium Phosphate Injection 20 mg

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

DRUGDexamethasone Sodium Phosphate Injection 4mg

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

Sponsors

The Methodist Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Global Quality of Life Score of Ureteral Stent Symptom Questionnaire (USSQ)Day 2 after surgeryA 1 to 7 rating scale used to measure survey participants' feeling if they were advised to have another stent inserted, from 1 = delighted to 7 = terrible.

Secondary

MeasureTime frameDescription
Urinary Index Score of the USSQDay 2 after surgeryThis domain assesses urinary symptoms (e.g., urgency, frequency, dysuria) and consists of multiple questions, each answered using a Likert-type scale. Higher scores indicate greater symptom severity.
Pain Index Score of the USSQDay 2 after surgeryThis domain assesses pain (e.g., flank pain, suprapubic discomfort) and consists of multiple questions, each answered using a Likert-type scale. Higher scores indicate greater symptom severity.
General Health Index Score of the USSQDay 2 after surgeryThis domain assesses general health (overall health perception and well-being) and consists of multiple questions, each answered using a Likert-type scale. Higher scores indicate greater symptom severity.
Work Performance Index Score of the USSQDay 2 after surgeryThis domain assesses work performance (impact of stent symptoms on work productivity) and consists of multiple questions, each answered using a Likert-type scale. Higher scores indicate greater symptom severity.
Opioid Use After SurgeryFrom intervention to stent removal at 4-7 days after surgeryThe amount of of prescribed opioid (in morphine equivalent dose) used during the time subjects have their stent in situ

Countries

United States

Contacts

CONTACTFarida Tufail
ftufail@houstonmethodist.org713-269-0186
CONTACTJohnny Su, MD
jssu@houstonmethodist.org
PRINCIPAL_INVESTIGATORMonica Morgan, MD

The Methodist Hospital Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026