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

Not Applicable

Completed

Conditions: Ureteral Obstruction

Interventions: Device: RELIEF Stent

Registration Number: NCT03266770

Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RELIEF stent placement	RELIEF Stent	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Bladder Irritation Symptoms (e.g. Frequency, Urgency, Nocturia, Urine Leakage...) Associated With the RELIEF Stent.	24 hours post op	Ureteral Stent Symptoms Questionnaire (USSQ Scale) will be used to evaluate bladder irritation symptoms at 24 hours post op. The USSQ produces a score of 19 to 220 or above where a higher score means more or worse symptoms.
Change in Loin Pain Scores From Baseline	Baseline, Day 30	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. The VAS produces a score of 0 to 10 where a higher score means more or worse symptoms.

Secondary Outcome Measures

Name	Time	Method
Incidence of RELIEF Stent-Related Adverse Events	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.