The RELIEF™ Ureteral Stent Randomized Controlled Trial

February 10, 2026 updated by: Seth Bechis, University of California, San Diego

The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care Ureteral Stent
Device: Standard of Care Ureteral Stent
The control product is the Ascerta stent by Boston Scientific.
Experimental: RELIEF Ureteral Stent
Device: RELIEF Ureteral Stent
The study intervention is placement of the RELIEF Ureteral Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrograde urine reflux
Time Frame: 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.
At time of stent placement - Day 0, and through study completion - an average of 12 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent symptoms
Time Frame: 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
Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

The Ureteral Stent Company

Investigators

  • Principal Investigator: Seth K Bechis, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 809792

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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