Access Sheath and Stent Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Surveys
Other interventionSurveys 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.
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: Stent omission armOther 1 intervention
Group B: Stent placement armOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (before procedure), 7-10 days after procedureSecondary outcomes
1
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.
Time frame
7-10 days after procedure2
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.
Time frame
4-6 weeks after procedure3
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).
Time frame
7-10 days after procedure4
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).
Time frame
4-6 weeks after procedureSponsors and contacts
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Source ClinicalTrials.gov