The RELIEF™ Ureteral Stent – Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position

Overview

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.

Full Title of Study: “The RELIEF™ Ureteral Stent – Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

Detailed Description

Traditional ureteral stents are commonly used in practice to relieve renal obstruction or as a scaffold to promote healing after endoscopic or open/ laparoscopic surgeries involving the ureter. However, there are many morbidities associated with stent placement either due to bladder irritation or backflow of urine to the kidney. The most commonly reported symptoms include urgency, urinary frequency, dysuria, incontinence, hematuria, suprapubic discomfort, and fever due to urinary tract infections and flank pain, which can occur in up to 80% of stented patients. Sometimes, the symptoms are poorly tolerated and can negatively affect patients' quality of life. Shao et al have studied the relationship between bladder filling and the renal pelvic pressure (RPP) in stented patients, which revealed that RPP increased mildly during bladder filling and increased dramatically during voiding, indicating urinary reflux, and thus encouraging early stent removal. Another study showed that patients with stents whose distal coils cross the midline are at higher risk of post-stenting morbidities. Replacement of the distal portion of the ureteral stent with a thin material may reduce bladder irritative symptoms and allow the ureterovesical junction to coapt, thereby eliminating urinary reflux. The Ureteral Stent Company, LLC (USC) is developing the RELIEF™ Ureteral Stent, a single use, disposable ureteral stent (US) device that will provide the traditional function of allowing the passage of urine from the kidney to the bladder with new design enhancements to improve patient care: – A low-profile tether through the intramural ureter segment, minimizing the potential of urinary reflux – Polymeric solid distal coil that minimizes the potential for coil positioning on the trigone, reducing the potential for associated bladder spasms and pain. It is hypothesized that the RELIEF stent will offer the same function of traditional ureteral stents with the added benefits of minimizing the urinary reflux and reducing irritative bladder symptoms.

Interventions

  • Device: RELIEF Stent
    • The RELIEF stent will be placed under cystoscopy. The stent with pusher will be placed over the guidewire and inserted. The pusher will be positioned, the guidewire will be removed, and the pusher will be retracted. The position of the stent will be confirmed by x-ray (C-arm).

Arms, Groups and Cohorts

  • Other: RELIEF stent placement
    • After meeting the inclusion criteria and being consented, patients will have the RELIEF stent inserted in the ureter during cystoscopy per standard of care for ureteral stent placement.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of bladder irritation symptoms (e.g. frequency, urgency, nocturia, urine leakage…) associated with the RELIEF Stent.
    • Time Frame: 0-30 days.
    • Ureteral Stent Symptoms Questionnaire (USSQ Scale) will be used to evaluate bladder irritation symptoms.
  • Change in loin pain scores from baseline
    • Time Frame: At 30 days.
    • The 1-10 Visual Analog Scale part of the Ureteral Stent Symptoms Questionnaire (USSQ Scale) will be used to evaluate the change of loin pain from baseline.

Secondary Measures

  • Incidence of RELIEF Stent-Related Adverse Events
    • Time Frame: 0-30 days.
    • Assessment of adverse events (incidence, relationship to device, severity) attributed to the RELIEF stent compared to established adverse event rates from published clinical studies and FDA reported events of conventional ureteral stents.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospitals Cleveland Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kyle Scarberry, Assistant Professor, Urology – University Hospitals Cleveland Medical Center
  • Overall Official(s)
    • Kyle Scarberry, MD, Principal Investigator, University Hospitals Cleveland Medical Center
  • Overall Contact(s)
    • Rosemary Brewka, MS, 216-844-1446, Rosemary.Brewka@uhhospitals.org

References

Chew BH, Knudsen BE, Denstedt JD. The use of stents in contemporary urology. Curr Opin Urol. 2004 Mar;14(2):111-5. Review.

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.

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.

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.

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.

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.

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