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Ureteral Stent-Related SymptomPhase 1/2DUSTSNCT06930690

Dexamethasone for Ureteral STent Symptoms (DUSTS)

A Phase 1/2 study testing Dexamethasone Sodium Phosphate Injection 20 mg and Dexamethasone Sodium Phosphate Injection 4mg in people with Ureteral Stent-Related Symptom, run by The Methodist Hospital Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ureteral Stent-Related Symptom
What is being tested?
Dexamethasone Sodium Phosphate Injection 20 mg and Dexamethasone Sodium Phosphate Injection 4mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
10 Jun 2026to Apr 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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
  • Patients with cognitive impairments or untreated psychiatric illness

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Houston Methodist Hospital

    Houston, Texas, 77005

    Farida Tufail, 713-269-0186, ftufail@houstonmethodist.org

    Monica Morgan, MD

    Recruiting

Other trials in United States

About this study

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

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
Read more

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
Read the 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.

Being tested
Dexamethasone Sodium Phosphate Injection 20 mg, Dexamethasone Sodium Phosphate Injection 4mg
Keywords
Ureteral Stent, Nephrolithiasis, Ureteral Stent Discomfort, Ureteral Stent-Related Symptom
Medical subject headings
Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone Sodium Phosphate Injection 20 mgDrug

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

  • Dexamethasone Sodium Phosphate Injection 4mgDrug

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

Study groups in NCT06930690
Study groupRoleWhat they receive
Treatment ArmExperimentalDexamethasone 20 mg
Receives: Drug: Dexamethasone Sodium Phosphate Injection 20 mg
Control ArmActive comparatorDexamethasone 4 mg
Receives: Drug: Dexamethasone Sodium Phosphate Injection 4mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 2 after surgery

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Day 2 after surgery

  5. Opioid Use After Surgery

    The amount of of prescribed opioid (in morphine equivalent dose) used during the time subjects have their stent in situ

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2025
  2. Study start10 Jun 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06930690
Sponsor's protocol ID
PRO00037902
Acronym
DUSTS
Status last verified
Oct 2026
First submitted
9 Apr 2025
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dexamethasone Sodium Phosphate Injection 20 mg and Dexamethasone Sodium Phosphate Injection 4mg in people with Ureteral Stent-Related Symptom, run by The Methodist Hospital Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Farida Tufail (713-269-0186, ftufail@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Quality of Life Score of Ureteral Stent Symptom Questionnaire (USSQ) (time frame: Day 2 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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