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.
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.
Johnny Su, MD contact
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77005
Farida Tufail, 713-269-0186, ftufail@houstonmethodist.org
Monica Morgan, MD
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:
- 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:
- randomly receive 20 mg or 4 mg of dexamethasone (20 mg) at the time of surgery
- fill out a questionnaire day 1 and day 2 after surgery
- fill out a medication diary for one week after surgery
- visit the clinic on day 2 after surgery for checkup
- 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.
- Conditions
- Ureteral Stent-Related Symptom
- 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 group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Dexamethasone 20 mg Receives: Drug: Dexamethasone Sodium Phosphate Injection 20 mg |
| Control Arm | Active comparator | Dexamethasone 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.
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)
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
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
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
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
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.
- First posted16 Apr 2025
- Study start10 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent-Related SymptomStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Morgan, The Methodist Hospital Research Institute
- Investigators
- Monica Morgan, MD, Principal investigator, The Methodist Hospital Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for Ureteral STent Symptoms (DUSTS): A Randomized, Double-blinded Controlled Study
- ClinicalTrials.gov ID
- NCT06930690
- Acronym / sponsor ID
- DUSTS / PRO00037902
- Conditions
- Ureteral Stent-Related Symptom
- Keywords
- Ureteral Stent, Nephrolithiasis, Ureteral Stent Discomfort, Ureteral Stent-Related Symptom
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- randomly receive 20 mg or 4 mg of dexamethasone (20 mg) at the time of surgery
- fill out a questionnaire day 1 and day 2 after surgery
- fill out a medication diary for one week after surgery
- visit the clinic on day 2 after surgery for checkup
- visit the clinic on day 4-7 after surgery for check up
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Dexamethasone Sodium Phosphate Injection 20 mgDexamethasone 20 mg |
| Control Arm | Active comparator | Drug: Dexamethasone Sodium Phosphate Injection 4mgDexamethasone 4 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Sodium Phosphate Injection 20 mgdexamethasone 20 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia | Drug | Treatment Arm |
| Dexamethasone Sodium Phosphate Injection 4mgdexamethasone 4 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia | Drug | Control Arm |
Primary outcome
Global Quality of Life Score of Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: Day 2 after surgery
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.
5 secondary outcomes
Urinary Index Score of the USSQ
Time frame: Day 2 after surgery
Pain Index Score of the USSQ
Time frame: Day 2 after surgery
General Health Index Score of the USSQ
Time frame: Day 2 after surgery
Work Performance Index Score of the USSQ
Time frame: Day 2 after surgery
Opioid Use After Surgery
Time frame: From intervention to stent removal at 4-7 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery
Opioid Consumption, Postoperative, Multimodal Analgesia
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Comparison of Ureteral Stent Designs in Children With Kidney Stones
Pediatric Urolithiasis, Ureteral Stent-Related Symptoms
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Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johnny Su, MD contact
Monica Morgan, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 5 Nov 2026.