Clinical trial NCT06720740: The RELIEF™ Ureteral Stent Randomized Controlled Trial
Official title: The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: ureteral stent
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: The Ureteral Stent Company
First posted: 2024-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Retrograde urine reflux
timeFrame: At time of stent placement - Day 0, and through study completion - an average of 12 weeks post-operatively
Secondary outcomes:
measure: Stent symptoms
timeFrame: Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Seth K Bechis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.