Kidney StoneACCENTNCT07297953
Access Sheath and Stent Trial
A study testing Surveys in people with Kidney Stone and Ureteral Stone, run by University of Michigan at 1 site in United States.
Trial summary
The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy. Participants that consent for the study will complete baseline PRO questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Ureteral Stone
- What is being tested?
- Surveys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to Oct 2026
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing ureteral stent (pre-stented)
- Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
- Renal stone defined as only renal location of stone(s)
- Ureteral stone defined as ureteral only location of stone(s)
Show all 9Show fewer
- Ureteral and renal stone(s)
- No evidence of significant ureteral injury on intra-operative assessment (Post-Ureteroscopy Lesion Scale (PULS) Grade 0 or 1)
- Ability and willingness to complete and adhere to survey questions and responses throughout study duration.
Who cannot join
- Pregnancy
- Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
- Evidence of ureteral stricture
- Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
- Known planned secondary or staged procedure
- Indwelling nephrostomy tube
- Bilateral ureteroscopy
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
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Elaina Shoemaker, 734-232-4906, esekulos@med.umich.edu
Kurshid Ghani, MS, FRCS
About this study
Official title: Access Sheath and stENT Trial
The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy.
Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size left to the discretion of the surgeon. At the end of the procedure, the urologist will evaluate the ureter for iatrogenic injury, and the ureter will be graded using the Post Ureteroscopic Lesion Scale (PULS). Patients assessed with PULS 0 and PULS 1 will meet 2nd stage eligibility and will be randomized 1:1 to either stent omission or stent placement. When a stent is placed, the stent type and decision to leave a string (tether) will be at the operating urologist's discretion.
Read more
Hypothesis:
- stent omission arm will be non-inferior to stent placement in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity, and have lower 30-day healthcare utilization.
- Conditions
- Kidney Stone, Ureteral Stone
- Being tested
- Surveys
- Keywords
- Ureteral stent, Ureteroscopy and lithotripsy, Surveys, Quality of life
- Medical subject headings
- Kidney Calculi, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.
| Study group | Role | What they receive |
|---|---|---|
| Stent omission arm | Other | Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease. Receives: Other: Surveys |
| Stent placement arm | Other | Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease. Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in PROMIS Pain Interference
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The scores range from 6-30 with a higher score indicating greater interference.
Measured: Baseline (before procedure), 7-10 days after procedure
Secondary outcomes (13)
Differences in PROMIS Pain intensity
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The scores range from 3-15 with a higher score indicating greater pain intensity.
Measured: 7-10 days after procedure
Differences in PROMIS Pain intensity
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The scores range from 3-15 with a higher score indicating greater pain intensity.
Measured: 4-6 weeks after procedure
Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother).
Measured: 7-10 days after procedure
Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10
The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother).
Measured: 4-6 weeks after procedure
Difference in PROMIS Social Roles & Activities
This is one question from the PROMIS that participants select from Never (5) to Always (1) whether there is trouble doing all of participant's usual work. A lower score indicates more trouble.
Measured: Daily after procedure (10 days or up to stent removal)
Difference in Pain intensity assessment based on the Visual analog scale
Participants pain level is selected from 0-10 with a higher score indicating greater pain.
Measured: Daily after procedure (10 days or up to stent removal)
Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S)
This is a 6-item questionnaire that participants complete regarding the satisfaction with treatment. The range of scores for each question is between 0-5, with a range of score between 0-24 with a higher score indicating greater satisfaction.
Measured: 7-10 days post procedure and 4 weeks
Count of days off work Patient
Measured: Day 7 post procedure and 4 weeks post procedure
Count of days off work Caregiver
Measured: Day 7 post procedure and 4 weeks post procedure
Composite healthcare utilization metric within 30 days (WinRatio)
WinRatio composite healthcare utilization score ranges from 1 to 6 based on each participants highest level of healthcare utilization, with higher score indicating a worse outcome: 6) Hospitalization and ICU care; 5) Unplanned hospitalization; 4) Additional OR or Interventional Radiology procedure 3) Emergency department visit; 2) Ambulatory encounter: clinic visit or diagnostic outpatient testing; 1) Ambulatory encounter: phone call or electronic medical record.
Measured: Up to 30 days after procedure
Abnormal imaging findings within 60 days
Urological imaging performed within 60 days per surgeon or patient preference.
Measured: within 60 days of procedure
Stone-free rates within 60 days
X-ray, Ultrasound, computerized tomography (CT) scan, or any combination
Measured: within 60 days of procedure
Differences in PROMIS Pain Interference
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The scores range from 6-30 with a higher score indicating greater interference.
Measured: 4-6 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start24 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khurshid Ghani, University of Michigan
- Investigators
- Khurshid Ghani, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297953
- Sponsor's protocol ID
- HUM00264257
- Acronym
- ACCENT
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access Sheath and stENT Trial
- ClinicalTrials.gov ID
- NCT07297953
- Acronym / sponsor ID
- ACCENT / HUM00264257
- Conditions
- Kidney Stone, Ureteral Stone
- Keywords
- Ureteral stent, Ureteroscopy and lithotripsy, Surveys, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Dec 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 study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy.
Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size left to the discretion of the surgeon. At the end of the procedure, the urologist will evaluate the ureter for iatrogenic injury, and the ureter will be graded using the Post Ureteroscopic Lesion Scale (PULS). Patients assessed with PULS 0 and PULS 1 will meet 2nd stage eligibility and will be randomized 1:1 to either stent omission or stent placement. When a stent is placed, the stent type and decision to leave a string (tether) will be at the operating urologist's discretion.
Hypothesis:
- stent omission arm will be non-inferior to stent placement in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity, and have lower 30-day healthcare utilization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent omission arm | Other | Other: SurveysParticipants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease. |
| Stent placement arm | Other | Other: SurveysParticipants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing ureteral stent (pre-stented)
- Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
- Renal stone defined as only renal location of stone(s)
Key exclusion criteria (7 listed)
- Pregnancy
- Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
- Evidence of ureteral stricture
- Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
- Known planned secondary or staged procedure
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 |
|---|---|---|
| SurveysSurveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information. | Other | Stent omission arm, Stent placement arm |
Primary outcome
Differences in PROMIS Pain Interference
Time frame: Baseline (before procedure), 7-10 days after procedure
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The scores range from 6-30 with a higher score indicating greater interference.
13 secondary outcomes
Differences in PROMIS Pain intensity
Time frame: 7-10 days after procedure
Differences in PROMIS Pain intensity
Time frame: 4-6 weeks after procedure
Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10
Time frame: 7-10 days after procedure
Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10
Time frame: 4-6 weeks after procedure
Difference in PROMIS Social Roles & Activities
Time frame: Daily after procedure (10 days or up to stent removal)
Difference in Pain intensity assessment based on the Visual analog scale
Time frame: Daily after procedure (10 days or up to stent removal)
Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S)
Time frame: 7-10 days post procedure and 4 weeks
Count of days off work Patient
Time frame: Day 7 post procedure and 4 weeks post procedure
Count of days off work Caregiver
Time frame: Day 7 post procedure and 4 weeks post procedure
Composite healthcare utilization metric within 30 days (WinRatio)
Time frame: Up to 30 days after procedure
Abnormal imaging findings within 60 days
Time frame: within 60 days of procedure
Stone-free rates within 60 days
Time frame: within 60 days of procedure
Differences in PROMIS Pain Interference
Time frame: 4-6 weeks after procedure
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 22 Dec 2025.
- 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.
Khurshid Ghani, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys in people with Kidney Stone and Ureteral Stone, run by University of Michigan 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 9 inclusion and 7 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 22 Dec 2025. 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?
Contact MUSIC Coordinating Center (734-232-4906, esekulos@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in PROMIS Pain Interference (time frame: Baseline (before procedure), 7-10 days after procedure). 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 22 Dec 2025.