Renal Stone, Ureteral Stone
Conditions
Keywords
Ureteral stent, Ureteroscopy, Lithotripsy
Brief summary
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.
Interventions
DEVICESilicone (Coloplast Imajin Hydro) ureteral stent
During the end of the standard of care ureteroscopy the silicone stent will be placed.
DEVICENon-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.
Sponsors
Coloplast A/S
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Renal stone defined as only renal location of stone(s). * Ureteral stone defined as ureteral only or ureteral and renal stone(s). * 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
* Known planned secondary or staged procedure * Presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney) * Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder) * Presence of any indwelling ureteral stent prior to ureteroscopy * Presence of any indwelling nephrostomy tube prior to ureteroscopy * Ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery * Renal stone located in calyceal diverticulum * No indication for stent placement (e.g. spontaneous passage) * Bladder stone location. * Pregnancy or lactation * Known allergic reactions to polyurethane or silicone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after 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 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days | Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery. | 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. |
| Change in NIH LURN SI-10 Scores at 4 to 6 Weeks | : 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. | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks | Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after 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 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. |
| Abnormal Imaging Findings Within 60 Days | up to 60 days | Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit. |
| Stone-free Rates Within 60 Days | up to 60 days | Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging. |
| Composite Healthcare Utilization Metric Within 30 Days (WinRatio) | up to 30 days | 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 |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks | Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 110 |
| 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. | 109 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No longer met eligibility criteria | 3 | 1 |
Baseline characteristics
| Characteristic | Silicone (Coloplast Imajin Hydro) Ureteral Stent | Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Total |
|---|---|---|---|
| Age, Continuous | 58 years | 59 years | 59 years |
| LURN SI-10 Baseline Measures | 8 units on a scale | 7 units on a scale | 7 units on a scale |
| PROMIS Pain Intensity | 51.4 units on a scale | 54.8 units on a scale | 54.8 units on a scale |
| PROMIS Pain Interference | 56.1 units on a scale | 59.1 units on a scale | 57.1 units on a scale |
| Race/Ethnicity, Customized African American | 4 Participants | 8 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasion | 95 Participants | 94 Participants | 189 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 101 Participants | 100 Participants | 201 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown/refused | 9 Participants | 7 Participants | 16 Participants |
| Race/Ethnicity, Customized Unknown/Refused | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 59 Participants | 57 Participants | 116 Participants |
| Sex: Female, Male Male | 51 Participants | 52 Participants | 103 Participants |
| Stone Location Renal Only | 59 Participants | 59 Participants | 118 Participants |
| Stone Location Ureter/Ureter + Renal | 48 Participants | 49 Participants | 97 Participants |
| Stone Location Withdrawn due to ineligibility | 3 Participants | 1 Participants | 4 Participants |
| Stone Size | 8 mm | 9 mm | 9 mm |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 108 |
| other Total, other adverse events | 11 / 107 | 10 / 108 |
| serious Total, serious adverse events | 3 / 107 | 2 / 108 |
Outcome results
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.
Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Population: Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days | 4.28 T-score |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days | 2.92 T-score |
p-value: 0.26Regression, Linear
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.
Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Population: Participants were only included in the analysis if they completed both the baseline survey and the follow-up survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days | 4.62 T-Score |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days | 3.24 T-Score |
p-value: 0.57Regression, Linear
Secondary
Abnormal Imaging Findings Within 60 Days
Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit.
Time frame: up to 60 days
Population: Only includes participants who received imaging (CT, US, and/or KUB) and were assessed for hydronephrosis within 60 days of URS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Abnormal Imaging Findings Within 60 Days | 7 Participants |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Abnormal Imaging Findings Within 60 Days | 6 Participants |
p-value: 0.44Chi-squared
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.
Time frame: Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Population: Participants were only included in the analysis if they completed both the baseline survey and the day 7-10 follow-up survey
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days | 2.53 units on a scale |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days | 2.90 units on a scale |
p-value: 0.5Mixed Models Analysis
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.
Time frame: : 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.
Population: Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Change in NIH LURN SI-10 Scores at 4 to 6 Weeks | -2.54 units on a scale |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Change in NIH LURN SI-10 Scores at 4 to 6 Weeks | -3.23 units on a scale |
p-value: 0.8Mixed Models Analysis
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.
Time frame: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Population: Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks | -6.60 T-Score |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks | -9.93 T-Score |
p-value: 0.58Regression, Linear
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.
Time frame: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Population: Participants were only analyzed for this outcome if the completed the baseline, 7-10 day, and 4-6 week questionnaires
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks | -6.38 T-Score |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks | -8.08 T-Score |
p-value: 0.72Regression, Linear
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
Time frame: up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Composite Healthcare Utilization Metric Within 30 Days (WinRatio) | 0 units on a scale |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Composite Healthcare Utilization Metric Within 30 Days (WinRatio) | 0 units on a scale |
p-value: 0.25WinRatio, unmatched unstratified
Secondary
Stone-free Rates Within 60 Days
Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging.
Time frame: up to 60 days
Population: Only includes participants who received imaging (CT, US, and/or KUB) within 60 days of URS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silicone (Coloplast Imajin Hydro) Ureteral Stent | Stone-free Rates Within 60 Days | 33 Participants |
| Non-silicone (Polyurethane/Percuflex) Ureteral Stent (Any Manufacturer). | Stone-free Rates Within 60 Days | 32 Participants |
p-value: 0.85Chi-squared