The RELIEF™ Ureteral Stent Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Kidney Stone

• Registration Number: NCT06720740
• Lead Sponsor: University of California, San Diego

Brief Summary

Assessment of the backwards flow of urine from the bladder into the ureter (retrograde urine reflux) after placement of the RELIEF® Ureteral Stent using imaging of the bladder after filling it with contrast and assigning a urinary reflux grade. Randomized controlled trial for evaluation of the stent placement and the adequacy of short term drainage (defined as the presence of the stent in the ureter and the lack of surgical or standard of care double J stent to treat symptoms associated with the stent itself on the stented side during the first 48 hours).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-25
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Has capacity to consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Persons, 18 years of age or older
• Male or female subjects with confirmed ureteral and/or renal stones or strictures documented via abdomen X-ray KUB (kidney ureter bladder) or CT (computed tomography)

Exclusion Criteria

• Distal ureteral obstruction where suture portion of stent may be placed
• Urinary reflux (assessed by pre-stent cystogram)
• Pregnancy or lactation
• Patients requiring bilateral surgical stone management procedure
• Infected stones
• Patients where 24cm or 26cm stent lengths are not suitable
• Ureteral structure in distal third of ureter
• Intraoperative exclusion: based on urologist's discretion, if trauma has been induced to the distal ureter due to ureteroscopy maneuvers, exclude these patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Retrograde urine reflux	At time of stent placement - Day 0, and through study completion - an average of 12 weeks post-operatively	Assessment of retrograde urine reflux after placement of a ureteral stent using cystography after contrast gravity-filling of the bladder and assigning a urinary reflux grade based on standard scoring.

Secondary Outcome Measures

Name	Time	Method
Stent symptoms	Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively	Assessment of stent symptoms (incidence, relationship to device, severity) attributed to the ureteral stent; Reporting the Ureteral Stent Symptoms Questionnaire (USSQ) before stent placement, after placement at day 3, prior to removal and post removal; Visualization of distal coil floating in bladder (Y/N) after stent placement