An interventional study of RELIEF Stent in Ureteral Obstruction, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
Among 11 studies in Ureteral Obstruction with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Ureteral Obstruction · United States.
Among the 11 studies in Ureteral Obstruction with a site in United States, this one is one of 2 that started in 2021, is one of 4 with no phase, and was the 8th registered.
33 studies on the registry are indexed under Ureteral Obstruction; 5 are open to participants now.
Browse Ureteral Obstruction studies →1 of the 11 studies in Ureteral Obstruction with a site in United States is open now. Recruiting first, the newest first:
University of Virginia · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1 Ureteral Obstruction studies recruiting now, 1 (100%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2021.
This study's enrollment of 24 is below the median of 83 across 22 interventional studies indexed under Ureteral Obstruction.
Median enrollment 42 across the 8 interventional studies, 64 across the 3 observational. Of the 9 that completed or were terminated, 5 (56%) have results posted.
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1 of 11 have an industry lead sponsor. The 10 most frequent:
University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
University Hospitals Cleveland Medical Center has 1 study filed under Ureteral Obstruction — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Ureteral Obstruction with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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).
Incidence of Bladder Irritation Symptoms (e.g. Frequency, Urgency, Nocturia, Urine Leakage...) Associated With the RELIEF Stent.
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.
Time frame: 24 hours post op
Change in Loin Pain Scores From Baseline
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.
Time frame: Baseline, Day 30
Incidence of RELIEF Stent-Related Adverse Events
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.
Time frame: 0-30 days.
| Milestone | RELIEF Stent Placement |
|---|---|
| Started | 24 |
| Completed | 19 |
| Not completed | 5 |
| Withdrew: Physician decision | 3 |
| Withdrew: Insufficient study supplies | 1 |
| Withdrew: Adverse event | 1 |
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.
| Units on a scale | RELIEF Stent Placement |
|---|---|
| Incidence of Bladder Irritation Symptoms (e.g. Frequency, Urgency, Nocturia, Urine Leakage...) Associated With the RELIEF Stent. | 51.95 ± 18.2 |
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.
| units on a scale | RELIEF Stent Placement |
|---|---|
| Baseline | 1.33 ± 2.69 |
| 30 days | 1.22 ± 2.11 |
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.
| Adverse Events | RELIEF Stent Placement |
|---|---|
| Incidence of RELIEF Stent-Related Adverse Events | 3 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RELIEF Stent Placement | 0/24 (0%) | 0/24 (0%) | 3/24 (12.5%) |
| Event | RELIEF Stent Placement |
|---|---|
| PainRenal and urinary disorders | 2/24 |
| HematuriaRenal and urinary disorders | 1/24 |
| Age, Categorical(Participants) | RELIEF Stent Placement |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 9 |
| Sex: Female, Male(Participants) | RELIEF Stent Placement |
|---|---|
| Female | 11 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | RELIEF Stent Placement |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | RELIEF Stent Placement |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers
Ran from Jun 2021 to primary completion in Dec 2022, 17 months.
Results were first posted in Feb 2024, 1 year 1 month after primary completion.
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