Kidney Stone, Ureteral Stone
Conditions
Keywords
Ureteral stent, Ureteroscopy and lithotripsy, Surveys, Quality of life
Brief 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. 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.
Interventions
OTHERSurveys
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Patients will be informed of the presence or absence of a stent immediately following participants surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in PROMIS Pain Interference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10 | 7-10 days after procedure | 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). |
| Difference in PROMIS Social Roles & Activities | Daily after procedure (10 days or up to stent removal) | 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. |
| Difference in Pain intensity assessment based on the Visual analog scale | Daily after procedure (10 days or up to stent removal) | Participants pain level is selected from 0-10 with a higher score indicating greater pain. |
| Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S) | 7-10 days post procedure and 4 weeks | 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. |
| Count of days off work Patient | Day 7 post procedure and 4 weeks post procedure | — |
| Differences in PROMIS Pain intensity | 7-10 days after procedure | 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. |
| Composite healthcare utilization metric within 30 days (WinRatio) | Up to 30 days after procedure | 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. |
| Abnormal imaging findings within 60 days | within 60 days of procedure | Urological imaging performed within 60 days per surgeon or patient preference. |
| Stone-free rates within 60 days | within 60 days of procedure | X-ray, Ultrasound, computerized tomography (CT) scan, or any combination |
| Differences in PROMIS Pain Interference | 4-6 weeks 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. |
| Count of days off work Caregiver | Day 7 post procedure and 4 weeks post procedure | — |
Countries
United States
Contacts
Primary ContactMUSIC Coordinating Center
Outcome results
None listed