Health TrialsbyHealthPanel

Dexamethasone for Ureteral STent Symptoms (DUSTS)

ConditionUreteral Stent-Related Symptom
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Methodist Hospital Research Institute

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Dexamethasone Sodium Phosphate Injection 4mg

    Drug

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

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.

Time frame
Day 2 after surgery

Secondary outcomes

1

Urinary Index Score of the USSQ

This 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.

Time frame
Day 2 after surgery
2

Pain Index Score of the USSQ

This 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.

Time frame
Day 2 after surgery
3

General Health Index Score of the USSQ

This 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.

Time frame
Day 2 after surgery
4

Work Performance Index Score of the USSQ

This 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.

Time frame
Day 2 after surgery

Other outcomes

1

Incidence of steroid-related adverse events

Incidence of the steroid-induced hyperglycemia (SIHG) as defined as random blood glucose ≥200 mg/dL and hyperglycemia-related adverse events including diabetic ketoacidosis (DKA) and hyperosmolar syndrome (HHS)

Time frame
Within 30 days
2

Incidence of UTIs

Incidence of symptomatic urinary tract infections (UTIs)

Time frame
Within 30 days
3

Number of ER visit or hospital admission

Number of unplanned emergency room visit or hospital admission

Time frame
Within 30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov
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