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| Name | Class |
|---|---|
| Coloplast A/S | INDUSTRY |
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This multi-center trial is being completed to compare patient outcomes related to the Imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy.
Eligible participants will be enrolled and randomly assigned to receive the Imajin silicone stent or a non-silicone stent. In addition, the participants will complete questionnaires and have follow-up information collected (approximately 60 days after surgery).
The trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone (Coloplast Imajin Hydro) ureteral stent | Experimental |
| |
| Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer). | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone (Coloplast Imajin Hydro) ureteral stent | Device | During the end of the standard of care ureteroscopy the silicone stent will be placed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days | 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 sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery. | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days | 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 sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 7-10 days after surgery. | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks | 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 sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery. |
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Inclusion Criteria:
Stated willingness to comply with all study procedures and availability for the duration of the study
Diagnosed with unilateral renal and/or ureteral stones with the largest less than or equal to (≤)2.0 cm in size measured on abdominal x-ray, Ultrasound or computerized tomography (CT) scan
Planned unilateral ureteroscopy with stent placement without stent string.
Ability to take oral medication.
Ability and willingness to complete and adhere to survey questions and responses throughout study duration.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khurshid Ghani, MD, MS, FRCS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Ann Arbor | Michigan | 48109 | United States | ||
| Michigan Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38545762 | Derived | Becker REN, DiBianco JM, Higgins AM, Konheim J, Kleer E, Leavitt D, King A, Kachroo N, Majdalany SE, Gandham D, Fernandez Moncaleano G, Conrado B, Shoemaker E, Daignault-Newton S, Dauw CA, Ghani KR. Daily Ecological Momentary Assessments of Pain and Ability to Work After Ureteroscopy and Stenting. J Endourol. 2024 Jun;38(6):545-551. doi: 10.1089/end.2023.0625. |
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For the purposes of this trial, enrollment was defined as those who were randomized, remained eligible prior to stent placement, and received the study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silicone (Coloplast Imajin Hydro) Ureteral Stent | Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed. |
| FG001 | Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2025 |
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| Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer) | Device | During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed. |
|
| Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks | 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 sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery. | Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. |
| Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days | 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). Change is defined as the difference in LURN SI-10 total score from baseline to 7-10 days after surgery. | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. |
| Change in NIH LURN SI-10 Scores at 4 to 6 Weeks | 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). Change is defined as the difference in LURN SI-10 total score from baseline to 4-6 weeks after surgery. | : Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. |
| Composite Healthcare Utilization Metric Within 30 Days (WinRatio) | WinRatio composite healthcare utilization score ranges from 0 to 5 based on each participants highest level of healthcare utilization, with higher score indicating a worse outcome: 0=no HCU, 1=phone call or EMR message, 2=office visit, 3= Emergency Department visit, 4=Unplanned Hospitalization, 5=Hospitalization with ICU care | up to 30 days |
| Abnormal Imaging Findings Within 60 Days | Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit. | up to 60 days |
| Stone-free Rates Within 60 Days | Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging. | up to 60 days |
| Brighton |
| Michigan |
| 48116 |
| United States |
| Chelsea Hospital (Saint Joseph Mercy) | Chelsea | Michigan | 48118 | United States |
| Henry Ford Macomb Hospital | Clinton Township | Michigan | 48038 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Ascension Hospital (Comprehensive Urology) | Novi | Michigan | 48374 | United States |
| William Beaumont Hospital (Michigan Institute of Urology) | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital (Michigan Institute of Urology) | Troy | Michigan | 48085 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital) | Ypsilanti | Michigan | 48197 | United States |
Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Silicone (Coloplast Imajin Hydro) Ureteral Stent | Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed. |
| BG001 | Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Stone Location | Kidney stone location for renal only versus ureteral | Count of Participants | Participants |
| |||||||||||||||
| Stone Size | Size of stone in millimeters | Median | Inter-Quartile Range | mm |
| ||||||||||||||
| 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 sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery. | *missing baseline PROMIS Pain Intensity due to non-response. | Median | Inter-Quartile Range | units on a scale |
| |||||||||||||
| 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 sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 7-10 days after surgery. | *missing baseline PROMIS Pain Interference due to non-response | Median | Inter-Quartile Range | units on a scale |
| |||||||||||||
| LURN SI-10 Baseline Measures | 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). Change is defined as the difference in LURN SI-10 total score from baseline to 7-10 days after surgery. | *missing baseline LURN SI-10 due to non-response. | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days | 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 sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery. | Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey | Posted | Mean | 97.5% Confidence Interval | T-score | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. |
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| Primary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days | 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 sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 7-10 days after surgery. | Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey. | Posted | Mean | 97.5% Confidence Interval | T-Score | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. |
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| Secondary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks | 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 sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery. | Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires | Posted | Mean | 95% Confidence Interval | T-Score | Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. |
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| Secondary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks | 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 sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 4-6 weeks after surgery. | Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires | Posted | Mean | 95% Confidence Interval | T-Score | Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. |
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| Secondary | Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days | 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). Change is defined as the difference in LURN SI-10 total score from baseline to 7-10 days after surgery. | Participants were only included in the analysis if they completed both the baseline survey and the day 7-10 follow-up survey | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. |
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| Secondary | Change in NIH LURN SI-10 Scores at 4 to 6 Weeks | 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). Change is defined as the difference in LURN SI-10 total score from baseline to 4-6 weeks after surgery. | Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires | Posted | Mean | 95% Confidence Interval | units on a scale | : Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. |
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| Secondary | Composite Healthcare Utilization Metric Within 30 Days (WinRatio) | WinRatio composite healthcare utilization score ranges from 0 to 5 based on each participants highest level of healthcare utilization, with higher score indicating a worse outcome: 0=no HCU, 1=phone call or EMR message, 2=office visit, 3= Emergency Department visit, 4=Unplanned Hospitalization, 5=Hospitalization with ICU care | Posted | Median | Inter-Quartile Range | units on a scale | up to 30 days |
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| Secondary | Abnormal Imaging Findings Within 60 Days | Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit. | Only includes participants who received imaging (CT, US, and/or KUB) and were assessed for hydronephrosis within 60 days of URS | Posted | Count of Participants | Participants | up to 60 days |
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| Secondary | Stone-free Rates Within 60 Days | Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging. | Only includes participants who received imaging (CT, US, and/or KUB) within 60 days of URS | Posted | Count of Participants | Participants | up to 60 days |
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Up to 60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silicone (Coloplast Imajin Hydro) Ureteral Stent | Silicone (Coloplast Imajin Hydro) ureteral stent: During the end of the standard of care ureteroscopy the silicone stent will be placed. | 0 | 107 | 3 | 107 | 11 | 107 |
| EG001 | Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer): During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed. | 0 | 108 | 2 | 108 | 10 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Renal and urinary disorders | Systematic Assessment |
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| Urinary Tract Infection (UTI) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Cystitis | Renal and urinary disorders | Systematic Assessment |
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| Flank Pain | Renal and urinary disorders | Systematic Assessment |
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| Nausea | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginitis | Reproductive system and breast disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Infected and obstructing ureteral stone with AKI | Renal and urinary disorders | Systematic Assessment |
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| Stent Displacement | Renal and urinary disorders | Systematic Assessment |
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| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
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| Flank Pain | Renal and urinary disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Fever | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Renal and Urinary Disorders |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Fall resulting in arthroplasty | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| COVID | General disorders | Systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| PE without acure cor pulmonale | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Obstructing Stone Fragment on Opposite Side | Renal and urinary disorders | Systematic Assessment |
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| Diarrhea and dehydration | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Khurshid Ghani, MD | University of Michigan | 734-763-2797 | kghani@med.umich.edu |
| Sep 12, 2025 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D014515 | Ureteral Diseases |
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