Ureteral Stent-Related SymptomNCT06979583
Impact of Ureteral Stent and Sheaths Size on Post-Operative Pain
A study testing 4.8 Fr Ureteral stents and 7 Fr Ureteral stents in people with Ureteral Stent-Related Symptom and Retrograde Intra-renal Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if post-operative stent size impacts stent-related pain and discomfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stent-Related Symptom, Retrograde Intra-renal Surgery
- What is being tested?
- 4.8 Fr Ureteral stents and 7 Fr Ureteral stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Jul 2027
- Phase
- Interventional
- 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 undergoing a retrograde intra-renal surgery (RIRS) (only patients undergoing the procedure for stone treatment will be included) who will require post-operative indwelling ureteral stent placement on a string at the conclusion of the procedure.
Who cannot join
- Patients with intra-operative ureteral injury who will require ureteral stent for extended time (more than 10 days, in that case a stent without a string will be used).
- Patient undergoing ureteroscopy for any indication other than stone extraction.
- Patients who are currently pregnant as determined by clinical presurgical screening.
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Impact of Ureteral Stent Size on the Management of Post Ureteroscopy Pain: a Randomized Single Blind Trial
The purpose of this study is to determine if post-operative stent size impacts stent-related pain and discomfort.
- Being tested
- 4.8 Fr Ureteral stents, 7 Fr Ureteral stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4.8 Fr Ureteral stentsDevice
After surgery, patients will have the Boston Scientific 4.8 Fr ureteral stent placed.
7 Fr Ureteral stentsDevice
After surgery, patients will have the Bard 7 Fr ureteral stent placed.
| Study group | Role | What they receive |
|---|---|---|
| Group A: 4.8 Fr Ureteral stents | Experimental | Not described Receives: Device: 4.8 Fr Ureteral stents |
| Group B: 7 Fr Ureteral stents | Experimental | Not described Receives: Device: 7 Fr Ureteral stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string
Post-operatively, patient will be contacted by study coordinators every day until stent is removed (usually 7-14 days after the surgery) to scale their stent pain on a scale from 1-5 as following: No pain: 1; Mild pain with no need for additional medication: 2; Mild pain with need for additional medication (anticholinergics): 3; Moderate stent pain (requiring narcotics): 4; Severe stent pain (requiring ER visit): 5.
Measured: Starting post-operatively, daily, until stent is removed (estimated 7-14 days)
Secondary outcomes (1)
Volume of post-operative correspondence between patients and medical system.
Total number of communications received from patient post-operatively.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study startMar 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 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 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan A. Cooper, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979583
- Sponsor's protocol ID
- 24-009000
- Status last verified
- Sep 2026
- First submitted
- 13 May 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ureteral Stent Size on the Management of Post Ureteroscopy Pain: a Randomized Single Blind Trial
- ClinicalTrials.gov ID
- NCT06979583
- Acronym / sponsor ID
- 24-009000
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 May 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 is to determine if post-operative stent size impacts stent-related pain and discomfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 4.8 Fr Ureteral stents | Experimental | Device: 4.8 Fr Ureteral stents |
| Group B: 7 Fr Ureteral stents | Experimental | Device: 7 Fr Ureteral stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a retrograde intra-renal surgery (RIRS) (only patients undergoing the procedure for stone treatment will be included) who will require post-operative indwelling ureteral stent placement on a string at the conclusion of the procedure.
Key exclusion criteria (3 listed)
- Patients with intra-operative ureteral injury who will require ureteral stent for extended time (more than 10 days, in that case a stent without a string will be used).
- Patient undergoing ureteroscopy for any indication other than stone extraction.
- Patients who are currently pregnant as determined by clinical presurgical screening.
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 |
|---|---|---|
| 4.8 Fr Ureteral stentsAfter surgery, patients will have the Boston Scientific 4.8 Fr ureteral stent placed. | Device | Group A: 4.8 Fr Ureteral stents |
| 7 Fr Ureteral stentsAfter surgery, patients will have the Bard 7 Fr ureteral stent placed. | Device | Group B: 7 Fr Ureteral stents |
Primary outcome
Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string
Time frame: Starting post-operatively, daily, until stent is removed (estimated 7-14 days)
Post-operatively, patient will be contacted by study coordinators every day until stent is removed (usually 7-14 days after the surgery) to scale their stent pain on a scale from 1-5 as following: No pain: 1; Mild pain with no need for additional medication: 2; Mild pain with need for additional medication (anticholinergics): 3; Moderate stent pain (requiring narcotics): 4; Severe stent pain (requiring ER visit): 5.
1 secondary outcome
Volume of post-operative correspondence between patients and medical system.
Time frame: 14 days
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 21 Sep 2026.
- 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.
Meghan A. Cooper, DO 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 study testing 4.8 Fr Ureteral stents and 7 Fr Ureteral stents in people with Ureteral Stent-Related Symptom and Retrograde Intra-renal Surgery, 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 21 Sep 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string (time frame: Starting post-operatively, daily, until stent is removed (estimated 7-14 days)). 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 21 Sep 2026.