Dexamethasone for Ureteral Stent Syndrome

(DUSTS Trial)

Overseen By Johnny Su, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: The Methodist Hospital Research Institute

Must not be taking: CYP3A4 inducers/inhibitors, Opioids

Disqualifiers: Diabetes, Immunosuppression, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a higher dose of dexamethasone, a long-acting steroid, can better relieve urinary symptoms and pain after kidney stone surgery with stent placement. It compares a standard dose to a higher dose to determine if it improves quality of life shortly after surgery. Patients scheduled for kidney stone surgery with stent placement and able to follow up at Houston Methodist Hospital might be suitable candidates. Participants will receive one of the two doses during surgery and will complete questionnaires and follow-up visits to track their recovery. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking strong CYP3A4 inducers or inhibitors within two weeks of screening or if you use chronic opioid analgesics.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that dexamethasone is generally well-tolerated. In studies where patients used dexamethasone for kidney-related procedures, it reduced pain without causing serious side effects. Although these studies have not fully established the safety of high doses of dexamethasone, the drug is typically safe for other conditions.

This trial is in its early stages (Phase 1/2), so researchers are closely studying the treatment's safety. Since dexamethasone is used safely for other medical issues, it is likely to be safe here as well. If approved, this research will provide more information on how well participants tolerate the higher dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for ureteral stent syndrome focus on pain relief and managing discomfort, often using medications like NSAIDs or alpha-blockers. Unlike these standard options, dexamethasone is a corticosteroid that works by reducing inflammation directly, which can potentially alleviate symptoms more effectively. Researchers are excited about this treatment because, in the experimental arm, a higher dose of 20 mg of dexamethasone is being tested, which might offer more significant relief compared to the lower 4 mg dose used in the control arm. This approach could lead to faster symptom relief and improved patient comfort, distinguishing it from current treatments.

What evidence suggests that high-dose dexamethasone might be an effective treatment for ureteral stent syndrome?

Research has shown that dexamethasone, a type of steroid, can greatly reduce pain and complications after ureteral stent removal. In this trial, participants will receive either a higher dose of dexamethasone (20 mg) or a regular dose (4 mg) to evaluate its effectiveness in easing urinary symptoms and pain. Studies have found that both higher and regular doses of dexamethasone alleviate these symptoms. Patients who took dexamethasone reported less pain and fewer missed workdays. The drug likely reduces swelling, which often causes pain and discomfort after surgery. Overall, dexamethasone effectively manages symptoms related to ureteral stents. ^{2 3 4 5 6}

Who Is on the Research Team?

Monica Morgan, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals experiencing urinary symptoms and pain after ureteroscopy with stent placement due to kidney stones. Participants must be suitable for high-dose steroid treatment, but specific inclusion criteria are not provided here.

Inclusion Criteria

Patients who can read and understand English

I can visit Houston Methodist Hospital within 7 days after surgery.

I am having a procedure to remove kidney stones with a stent placement.

Exclusion Criteria

HbA1c ≥6.5 on preoperative testing

Urinary diversion

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either 20 mg or 4 mg of dexamethasone at the time of surgery

1 day

1 visit (in-person)

Postoperative Monitoring

Participants fill out questionnaires and medication diaries, and have follow-up visits for stent removal and monitoring of blood glucose levels

7 days

2 visits (in-person)

Follow-up

Participants are monitored for adverse events and quality of life, with a final follow-up call on day 30

30 days

1 call (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The study tests if a high dose of dexamethasone (20 mg) can improve quality of life better than a standard dose (4 mg) post-surgery. Patients will be randomly assigned one of the two doses during surgery and monitored through questionnaires and clinic visits.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Dexamethasone 20 mg

Group II: Control Arm Active Control 1 Intervention

Dexamethasone 4 mg

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11918725/

a randomized triple-blind, placebo-controlled clinical trial Conclusion: Intramuscular ketorolac and dexamethasone significantly reduce pain and related complications following stent removal, providing an ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650345/

Dexamethasone: a cheap and convenient way to alleviate ... In conclusion, the results of our study clearly demonstrate that DEX significantly ameliorates heating-induced ureteral injury, resulting in ...

3. isrctn.com isrctn.com/pdf/14221501

Effect of ketorolac and dexamethasone injections on pain ... The possible benefits are decreased level of kidney pain and fewer missed days of work after stent removal. The possible risks are injection ...

4. withpower.com withpower.com/trial/phase-2-ureteral-stent-related-symptom-4-2025-3aa87

Dexamethasone for Ureteral Stent Syndrome (DUSTS Trial) 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 ...

5. researchgate.net researchgate.net/publication/388559749_Efficacy_and_safety_of_ketorolac_and_dexamethasone_for_preventing_renal_colic_post_stent_removal_a_randomized_triple-blind_placebo-controlled_clinical_trial

a randomized triple-blind, placebo-controlled clinical trial The primary outcome was the visual analog scale (VAS) score for pain, assessed at 1- and 7-days post-stent removal. Secondary outcomes included ...

6. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/02000/efficacy_and_safety_of_ketorolac_and_dexamethasone.21.aspx

a randomized triple-blind, placebo-controlled clinical trial This study aims to evaluate the efficacy and safety of intramuscular ketorolac and dexamethasone in preventing renal colic after stent removal.