Ureter Obstruction
Conditions
Brief summary
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
Detailed description
A multi-center registry study to obtain post-market clinical data on safety and effectiveness of the Boston Scientific Ureteral and Urinary Diversion Stents
Interventions
DEVICEBoston Scientific Ureteral Stents, Urinary Diversion Stent
A BSC Ureteral Stent is an implantable device that is used to restore flow of urine from the kidney to the bladder in obstructed ureters. A BSC Urinary Diversion Stent is an implantable device that is used to restore flow of urine from the kidney.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
(for all Ureteral stent types except Urinary Diversion Stents): * Subject is undergoing placement of a Boston Scientific Ureteral Stent * Subject anatomy is appropriate to accommodate a stent size available in the study * Subject is able to accurately detect and report bladder function and pain * Subject is willing and able to: * Complete patient QoL questionnaire at specified time points (for subjects aged ≥ 18 years) * Return for all follow-up visits Inclusion Criteria (for Urinary Diversion Stents): * Subject is undergoing placement of a Boston Scientific Urinary Diversion Stent(s) * The anatomical features of the involved renal collecting system are known by either prior or concurrent urography or axial CT imaging * Subject is willing and able to return for all follow-up visits
Exclusion criteria
(for Ureteral stents and Urinary Diversion Stents): * Subjects who meet any of the contraindications per individual stent DFU * Subjects receiving different stent type in case of bilateral/multiple stenting * Subjects with an indwelling ureteral stent(s) not planned to be removed prior to/or concurrently with the study stent implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Implanted Stents Meeting the Technical Success Criteria | 2 months to 15 Months | Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters. |
| Primary Safety Endpoint | 2 months to 15 Months | Any Serious Adverse Device Effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - Patient-Reported Outcomes | Change From Index Procedure to Stent Removal Visit; Change From Index Procedure to Post Stent Removal Visit Stent Removal: Typically, within 2 weeks to < 365 days from Index Procedure Post-Stent Removal: Typically, 3 - 12 weeks from Stent Removal | Measurement System Patient Reported Outcomes Measurement Information System (PROMIS®) for subjects ≥18 years * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity 3a, score range for the change from Index procedure is -41.1 to 41.1 * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference 6b, score range for the change from Index procedure is -37.3 to 37.3 Higher PROMIS score means worse quality of life |
| Stent Migration | 2 months to 15 Months | Stent Migration: Confirmed via imaging |
Countries
Canada, France, Japan, United States
Contacts
PRINCIPAL_INVESTIGATORAmy Krambeck
Northwestern University
PRINCIPAL_INVESTIGATORMichael Borofsky
University of Minnesota
Participant flow
Recruitment details
Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study.
Pre-assignment details
This section is not applicable.
Participants by arm
| Arm | Count |
|---|---|
| Boston Scientific Ureteral Stents - Tria Subjects were treated with Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. | 215 |
| Boston Scientific Ureteral Stents - Non-Tria Subjects were treated with non-Tria Boston Scientific Ureteral Stent(s). Subjects were generally recruited from physician's practice and met the indications for a ureteral stent implant per the IFU/DFU. Any subject who intended to receive BSC Ureteral Stent(s) as part of their standard of care and was willing to provide a written informed consent was approached and considered for enrollment in the study. | 144 |
| Total | 359 |
Baseline characteristics
| Characteristic | Boston Scientific Ureteral Stents - Non-Tria | Boston Scientific Ureteral Stents - Tria | Total |
|---|---|---|---|
| Age, Continuous | 60.0 years | 57.2 years | 58.4 years |
| Quality of Life Endpoint - Patient-Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a | 43.15 units on a scale | 44.34 units on a scale | 43.86 units on a scale |
| Quality of Life Endpoint - Patient-Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6b | 53.85 units on a scale | 55.09 units on a scale | 54.59 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 18 participants | 29 participants | 47 participants |
| Region of Enrollment France | 28 participants | 0 participants | 28 participants |
| Region of Enrollment Japan | 0 participants | 20 participants | 20 participants |
| Region of Enrollment United States | 98 participants | 166 participants | 264 participants |
| Sex: Female, Male Female | 58 Participants | 99 Participants | 157 Participants |
| Sex: Female, Male Male | 86 Participants | 116 Participants | 202 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 215 | 0 / 144 |
| other Total, other adverse events | 57 / 215 | 40 / 144 |
| serious Total, serious adverse events | 9 / 215 | 5 / 144 |
Outcome results
Primary
Percentage of Implanted Stents Meeting the Technical Success Criteria
Technical success was defined as: a stented kidney drains (to bladder) during the planned indwell time with no re-intervention due to obstruction of the stented ureters.
Time frame: 2 months to 15 Months
Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. Number of units analyzed are stents implanted for more than 12 hours. Results were summarized by Tria and Non-Tria separately. Performance goal was 85% for Tria stone management.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Boston Scientific Ureteral Stents - Tria | Percentage of Implanted Stents Meeting the Technical Success Criteria | Technical Success Criteria Met | 242 Stent Implanted |
| Boston Scientific Ureteral Stents - Tria | Percentage of Implanted Stents Meeting the Technical Success Criteria | Technical Success Criteria Not Met | 4 Stent Implanted |
| Boston Scientific Ureteral Stents - Non-Tria | Percentage of Implanted Stents Meeting the Technical Success Criteria | Technical Success Criteria Met | 158 Stent Implanted |
| Boston Scientific Ureteral Stents - Non-Tria | Percentage of Implanted Stents Meeting the Technical Success Criteria | Technical Success Criteria Not Met | 2 Stent Implanted |
95% CI: [0.948, 0.995]
Primary
Primary Safety Endpoint
Any Serious Adverse Device Effects
Time frame: 2 months to 15 Months
Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boston Scientific Ureteral Stents - Tria | Primary Safety Endpoint | SADE Experienced | 2 Participants |
| Boston Scientific Ureteral Stents - Tria | Primary Safety Endpoint | No SADEs Experienced | 213 Participants |
| Boston Scientific Ureteral Stents - Non-Tria | Primary Safety Endpoint | SADE Experienced | 3 Participants |
| Boston Scientific Ureteral Stents - Non-Tria | Primary Safety Endpoint | No SADEs Experienced | 141 Participants |
Secondary
Quality of Life - Patient-Reported Outcomes
Measurement System Patient Reported Outcomes Measurement Information System (PROMIS®) for subjects ≥18 years * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity 3a, score range for the change from Index procedure is -41.1 to 41.1 * Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference 6b, score range for the change from Index procedure is -37.3 to 37.3 Higher PROMIS score means worse quality of life
Time frame: Change From Index Procedure to Stent Removal Visit; Change From Index Procedure to Post Stent Removal Visit Stent Removal: Typically, within 2 weeks to < 365 days from Index Procedure Post-Stent Removal: Typically, 3 - 12 weeks from Stent Removal
Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Boston Scientific Ureteral Stents - Tria | Quality of Life - Patient-Reported Outcomes | Pain Intensity Score Change From Index Procedure to Stent Removal Visit | -1.83 score on a scale |
| Boston Scientific Ureteral Stents - Tria | Quality of Life - Patient-Reported Outcomes | Pain Intensity Score Change From Index Procedure to Post Stent Removal Visit | -9.51 score on a scale |
| Boston Scientific Ureteral Stents - Tria | Quality of Life - Patient-Reported Outcomes | Pain Interference Score Change From Index Procedure to Stent Removal Visit | -2.76 score on a scale |
| Boston Scientific Ureteral Stents - Tria | Quality of Life - Patient-Reported Outcomes | Pain Interference Score Change From Index Procedure to Post Stent Removal Visit | -10.99 score on a scale |
| Boston Scientific Ureteral Stents - Non-Tria | Quality of Life - Patient-Reported Outcomes | Pain Interference Score Change From Index Procedure to Post Stent Removal Visit | -11.14 score on a scale |
| Boston Scientific Ureteral Stents - Non-Tria | Quality of Life - Patient-Reported Outcomes | Pain Intensity Score Change From Index Procedure to Stent Removal Visit | 2.04 score on a scale |
| Boston Scientific Ureteral Stents - Non-Tria | Quality of Life - Patient-Reported Outcomes | Pain Interference Score Change From Index Procedure to Stent Removal Visit | 2.25 score on a scale |
| Boston Scientific Ureteral Stents - Non-Tria | Quality of Life - Patient-Reported Outcomes | Pain Intensity Score Change From Index Procedure to Post Stent Removal Visit | -10.79 score on a scale |
Secondary
Stent Migration
Stent Migration: Confirmed via imaging
Time frame: 2 months to 15 Months
Population: Subjects who provided consent and for whom a Boston Scientific stent placement procedure was initiated were included. Number of units analyzed are for all stents implanted.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Boston Scientific Ureteral Stents - Tria | Stent Migration | Stent Migration | 3 Stent Implanted |
| Boston Scientific Ureteral Stents - Tria | Stent Migration | No Stent Migration | 260 Stent Implanted |
| Boston Scientific Ureteral Stents - Non-Tria | Stent Migration | No Stent Migration | 163 Stent Implanted |
| Boston Scientific Ureteral Stents - Non-Tria | Stent Migration | Stent Migration | 2 Stent Implanted |