Dexamethasone for Ureteral STent Symptoms (DUSTS)

NCT06930690 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRO00037902
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Ureteral Stent-Related Symptom

Keywords

Ureteral Stent; Nephrolithiasis; Ureteral Stent Discomfort; Ureteral Stent-Related Symptom

Outcome Measures

Primary Outcomes (1)

• Global Quality of Life Score of Ureteral Stent Symptom Questionnaire (USSQ)

  A 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.

  Day 2 after surgery

Secondary Outcomes (5)

• Urinary Index Score of the USSQ

  Day 2 after surgery

• Pain Index Score of the USSQ

  Day 2 after surgery

• General Health Index Score of the USSQ

  Day 2 after surgery

• Work Performance Index Score of the USSQ

  Day 2 after surgery

• Opioid Use After Surgery

  From intervention to stent removal at 4-7 days after surgery

Other Outcomes (3)

• Incidence of steroid-related adverse events

  Within 30 days

• Incidence of UTIs

  Within 30 days

• Number of ER visit or hospital admission

  Within 30 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Dexamethasone 20 mg

Drug: Dexamethasone Sodium Phosphate Injection 20 mg

Control Arm

ACTIVE COMPARATOR

Dexamethasone 4 mg

Drug: Dexamethasone Sodium Phosphate Injection 4mg

Interventions

Dexamethasone Sodium Phosphate Injection 20 mg DRUG

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

Treatment Arm

Dexamethasone Sodium Phosphate Injection 4mg DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77005, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Monica Morgan, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farida Tufail

CONTACT

713-269-0186; ftufail@houstonmethodist.org

Johnny Su, MD

CONTACT

jssu@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Urology

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)