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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent omission arm | Other | Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease. |
|
| Stent placement arm | Other | Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (before procedure), 7-10 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7-10 days after procedure |
| Differences in PROMIS Pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MUSIC Coordinating Center | Contact | 734-232-4906 | esekulos@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Khurshid Ghani, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Patients will be informed of the presence or absence of a stent immediately following participants surgery.
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. |
| 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). | 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). | 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. | 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. | 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. | 7-10 days post procedure and 4 weeks |
| Count of days off work Patient | Day 7 post procedure and 4 weeks post procedure |
| Count of days off work Caregiver | 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. | Up to 30 days after procedure |
| Abnormal imaging findings within 60 days | Urological imaging performed within 60 days per surgeon or patient preference. | within 60 days of procedure |
| Stone-free rates within 60 days | X-ray, Ultrasound, computerized tomography (CT) scan, or any combination | 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. | 4-6 weeks after procedure |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014515 | Ureteral Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |