Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03266770
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2017-08-17
Brief Title:
The RELIEF Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
The RELIEF Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None