The RELIEF™ Ureteral Stent Randomized Controlled Trial

NCT06720740 | Withdrawn FDA Device

• 1 other identifier: 809792
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Kidney Stone

Keywords

ureteral stent

Outcome Measures

Primary Outcomes (1)

• Retrograde urine reflux

  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 Outcomes (1)

• Stent symptoms

  Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively

Study Arms (2)

Standard of Care Ureteral Stent

ACTIVE COMPARATOR

Device: Standard of Care Ureteral Stent

RELIEF Ureteral Stent

EXPERIMENTAL

Device: RELIEF Ureteral Stent

Interventions

RELIEF Ureteral Stent DEVICE

The study intervention is placement of the RELIEF Ureteral Stent

RELIEF Ureteral Stent

Standard of Care Ureteral Stent DEVICE

The control product is the Ascerta stent by Boston Scientific.

Standard of Care Ureteral Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• The Ureteral Stent Company: collaborator

Related Publications (6)

• Chew BH, Knudsen BE, Denstedt JD. The use of stents in contemporary urology. Curr Opin Urol. 2004 Mar;14(2):111-5. doi: 10.1097/00042307-200403000-00011.

  PMID: 15075840 BACKGROUND

• Joshi HB, Okeke A, Newns N, Keeley FX Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002 Apr;59(4):511-6. doi: 10.1016/s0090-4295(01)01644-2.

  PMID: 11927301 BACKGROUND

• Chambade D, Thibault F, Niang L, Lakmichi MA, Gattegno B, Thibault P, Traxer O. [Study of the safety of double J ureteric stents]. Prog Urol. 2006 Sep;16(4):445-9. French.

  PMID: 17069037 BACKGROUND

• Shao Y, Shen ZJ, Zhuo J, Liu HT, Yu SQ, Xia SJ. The influence of ureteral stent on renal pelvic pressure in vivo. Urol Res. 2009 Aug;37(4):221-5. doi: 10.1007/s00240-009-0199-z. Epub 2009 Jun 10.

  PMID: 19513705 BACKGROUND

• Giannarini G, Keeley FX Jr, Valent F, Manassero F, Mogorovich A, Autorino R, Selli C. Predictors of morbidity in patients with indwelling ureteric stents: results of a prospective study using the validated Ureteric Stent Symptoms Questionnaire. BJU Int. 2011 Feb;107(4):648-54. doi: 10.1111/j.1464-410X.2010.09482.x.

  PMID: 20590539 BACKGROUND

• Krebs A, Deane LA, Borin JF, Edwards RA, Sala LG, Khan F, Abdelshehid C, McDougall EM, Clayman RV. The 'buoy' stent: evaluation of a prototype indwelling ureteric stent in a porcine model. BJU Int. 2009 Jul;104(1):88-92. doi: 10.1111/j.1464-410X.2008.08338.x. Epub 2009 Jan 14.

  PMID: 19154469 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Seth K Bechis, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02