UreteroscopyPhase 4NCT07223580
A Study Of Corticosteroid On Postoperative Pain After Ureteroscopy For Urinary Calculi
A Phase 4 study testing Corticosteroid in people with Ureteroscopy and Post Operative Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate if corticosteroid (prednisone) after ureteroscopy and placement of the stent will help alleviate postoperative pain control in addition to other normal postoperative pain medications Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteroscopy, Post Operative Pain
- What is being tested?
- Corticosteroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to 1 Dec 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen or pelvis) and who elect for definitive treatment via ureteroscopy with placement of ureteral stent.
- Age 18 years or older
- Patients of either gender
- Patients of all ethnic backgrounds
- Cable of giving informed consent
- Capable and willing to fulfill the requirements of the study.
Who cannot join
- History of chronic pain
- Chronic use of opioids or other pain medication (>12 weeks)
- Known allergies to corticosteroids.
- Known or suspected pregnancy
- Inability to give informed consent or unable to meet requirements of the study for any reason.
- Bilateral ureteroscopy
- Current Corticosteroid Use
- Diabetic patients who are insulin dependent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rev V. Vilasan Shylaja contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Rev V. Vilasan Shylaja, 480-574-1466
Karen L. Stern, MD
About this study
Official title: Evaluating The Role Of Corticosteroids In Post-Ureteroscopy Recovery For Urinary Calculi
The purpose of this research is to evaluate if corticosteroid (prednisone) after ureteroscopy and placement of the stent will help alleviate postoperative pain control in addition to other normal postoperative pain medications
- Conditions
- Ureteroscopy, Post Operative Pain
- Being tested
- Corticosteroid, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called Prednisone
In addition to the standard of care postoperative ureteroscopy medication, participants will be given prednisone 25 mg orally, once a day for 5 days post-surgery.
PlaceboOther
In addition to the standard of care postoperative ureteroscopy medication, participants will be given a placebo pill orally, once a day for 5 days post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care plus Corticosteroid | Experimental | Participants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg. Receives: Drug: Corticosteroid |
| Standard of Care | Placebo comparator | Participants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale Pain Score
Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.
Measured: Baseline, Day 1 (Post-operatively), Day 2, Day 3
Secondary outcomes (4)
Number of times non-opioid analgesics medication used
Total number of times participants used non-opioid analgesics medication
Measured: 3 days
Cumulative usage of non-opioid analgesics medication
Total use of non-opioid analgesics medication of any kind, reported in mg
Measured: 3 days
Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score
The Wisconsin Stone Quality of Life (WISQOL) questionnaire is a 29 item survey that assesses quality of life for participants with kidney stones and covers four domains: social impact, emotional impact, stone-related symptom impact, and vitality. Questions are answered on a 5-point Likert scale, (1 = Very true, 5 = Not at all true), with a total maximum score of 140. Higher scores indicate a better quality of life.
Measured: Day 2 (Post-operatively), Day 3
Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score
The Canadian Endourology Group Stent Symptom Score (CEGSSS) is a 11-item questionnaire that assesses ureteral stent symptoms through three domains: urination, pain, and quality of life. Scoring is based on participant responses to the individual questions, with higher scores indicating a greater symptom burden.
Measured: Day 1 (Post-operatively), Day 2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start23 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreteroscopyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen L. Stern, Mayo Clinic
- Investigators
- Karen L. Stern, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223580
- Sponsor's protocol ID
- 25-003416
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Role Of Corticosteroids In Post-Ureteroscopy Recovery For Urinary Calculi
- ClinicalTrials.gov ID
- NCT07223580
- Acronym / sponsor ID
- 25-003416
- Conditions
- Ureteroscopy, Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Nov 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 research is to evaluate if corticosteroid (prednisone) after ureteroscopy and placement of the stent will help alleviate postoperative pain control in addition to other normal postoperative pain medications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care plus Corticosteroid | Experimental | Drug: CorticosteroidParticipants will receive standard of care postoperative ureteroscopy medication, with the addition of prednisone 25 mg. |
| Standard of Care | Placebo comparator | Other: PlaceboParticipants will receive standard of care postoperative ureteroscopy medication, with the addition of a placebo pill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen or pelvis) and who elect for definitive treatment via ureteroscopy with placement of ureteral stent.
- Age 18 years or older
- Patients of either gender
- Patients of all ethnic backgrounds
- Cable of giving informed consent
Key exclusion criteria (8 listed)
- History of chronic pain
- Chronic use of opioids or other pain medication (>12 weeks)
- Known allergies to corticosteroids.
- Known or suspected pregnancy
- Inability to give informed consent or unable to meet requirements of the study for any reason.
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 |
|---|---|---|
| CorticosteroidAlso: PrednisoneIn addition to the standard of care postoperative ureteroscopy medication, participants will be given prednisone 25 mg orally, once a day for 5 days post-surgery. | Drug | Standard of care plus Corticosteroid |
| PlaceboIn addition to the standard of care postoperative ureteroscopy medication, participants will be given a placebo pill orally, once a day for 5 days post-surgery. | Other | Standard of Care |
Primary outcome
Change in Visual Analog Scale Pain Score
Time frame: Baseline, Day 1 (Post-operatively), Day 2, Day 3
Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.
4 secondary outcomes
Number of times non-opioid analgesics medication used
Time frame: 3 days
Cumulative usage of non-opioid analgesics medication
Time frame: 3 days
Change in Wisconsin Stone Quality of Life Questionnaire (WISQOL) score
Time frame: Day 2 (Post-operatively), Day 3
Change in Canadian Endourology Group Stent Symptom Score (CEGSSS) score
Time frame: Day 1 (Post-operatively), Day 2, Day 3
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 3 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rev V. Vilasan Shylaja contact
Karen L. Stern, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid in people with Ureteroscopy and Post Operative Pain, run by Mayo Clinic 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 6 inclusion and 8 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 3 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Rev V. Vilasan Shylaja (480-574-1466), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale Pain Score (time frame: Baseline, Day 1 (Post-operatively), Day 2, Day 3). 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 3 Feb 2026.