N/A
N=24
The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position
Ureteral Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT03266770 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Incidence of Bladder Irritation Symptoms (e.g. Frequency, Urgency, Nocturia, Urine Leakage...) Associated With the RELIEF Stent. — 51.95 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RELIEF Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Bladder Irritation Symptoms (e.g. Frequency, Urgency, Nocturia, Urine Leakage...) Associated With the RELIEF Stent. |
51.95 | — |
| PRIMARY Change in Loin Pain Scores From Baseline |
1.33; 1.22 | 0.83 |
| SECONDARY Incidence of RELIEF Stent-Related Adverse Events |
3 | — |
Summary
Traditional ureteral stents are commonly used in renal and ureteral procedures, and their use is associated with many morbidities which can affect patients' quality of life. However, replacement of the distal portion of the stent with a thin material may reduce bladder irritative symptoms and allow the ureterovesical junction to coapt---thereby, reducing urinary reflux. The hypothesis is that the RELIEF stent will offer the same function of traditional ureteral stents with the added benefits of minimizing urinary reflux and reducing irritative bladder symptoms.
Eligibility Criteria
Inclusion Criteria
- Ureteral stone of 5-25 mm measured on plain abdomen X-ray KUB (Kidney Ureter Bladder) or CT (computed tomography).
- Upper or middle third ureteral stricture.
Exclusion Criteria
- Patients with distal ureteral obstruction
- Patients with urinary reflux
- Patients requiring bilateral surgical stone management procedure
- Intraoperative exclusion: Based on the urologist's discretion, if trauma has been induced to the distal ureter due to ureteroscopy maneuvers, these patients will be excluded.
Data sourced from ClinicalTrials.gov (NCT03266770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.