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

70 Participants Needed

Trial Summary

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 Dexamethasone safe for humans?

The provided research articles do not contain specific safety information about Dexamethasone for ureteral stent syndrome or other conditions. ^{1 2 3 4 5}

How is the drug dexamethasone unique for treating ureteral stent syndrome?

Dexamethasone is unique for treating ureteral stent syndrome because it is a corticosteroid that can help reduce inflammation and relieve symptoms associated with ureteral obstruction, which is not a standard approach for managing stent-related symptoms. This anti-inflammatory effect can improve comfort and potentially avoid more invasive procedures. ^{6 7 8 9 10}

What is the purpose of this 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 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

Research Team

Monica Morgan, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Indwelling ureteral stents: evaluation of quality of life to aid outcome analysis. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Comparation of intraureteral stent and conventional stent at different stages: a systematic review with meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Outcomes of stenting after uncomplicated ureteroscopy: systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Patients' Experiences With the Removal of a Ureteral Stent: Insights From In-depth Interviews With Participants in the USDRN STENTS Qualitative Cohort Study. [2023]

6. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Retained fragmented double J ureteric stent: A report of four cases with review of the literature. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

The role of solifenacin, as monotherapy or combination with tamsulosin in ureteral stent-related symptoms: a systematic review and meta-analysis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of ureteral stent diameter on symptoms and tolerability. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Use of dexamethasone for ureteric obstruction in advanced prostate cancer: percutaneous nephrostomies can be avoided. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Malignant ureteric obstruction relieved by dexamethasone. [2019]