Ureteral ObstructionNCT03266770
The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position
A study testing RELIEF Stent in people with Ureteral Obstruction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Obstruction
- What is being tested?
- RELIEF Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Ureteral Obstruction
- Being tested
- RELIEF Stent
- Keywords
- ureteral stent
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELIEF StentDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| RELIEF stent placement | Other | 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. Receives: Device: RELIEF Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Day 30
Secondary outcomes (1)
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.
Measured: 0-30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start15 Jun 2021
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ureteral ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Scarberry, MD, University Hospitals Cleveland Medical Center
- Investigators
- Kyle Scarberry, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266770
- Sponsor's protocol ID
- 04-17-30
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2017
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers
Publications
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.
PubMed 15075840Joshi 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.
PubMed 11927301Chambade 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.
PubMed 17069037Shao 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.
PubMed 19513705Giannarini 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.
PubMed 20590539Krebs 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.
PubMed 19154469
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position
- ClinicalTrials.gov ID
- NCT03266770
- Acronym / sponsor ID
- 04-17-30
- Conditions
- Ureteral Obstruction
- Keywords
- ureteral stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RELIEF stent placement | Other | Device: RELIEF StentAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELIEF StentThe 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). | Device | RELIEF stent placement |
Primary outcome
Incidence of Bladder Irritation Symptoms (e.g. Frequency, Urgency, Nocturia, Urine Leakage...) Associated With the RELIEF Stent.
Time frame: 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
Time frame: 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.
1 secondary outcome
Incidence of RELIEF Stent-Related Adverse Events
Time frame: 0-30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15075840Chew 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.
- Background: PubMed 11927301Joshi 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.
- Background: PubMed 17069037Chambade 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.
- Background: PubMed 19513705Shao 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.
- Background: PubMed 20590539Giannarini 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.
- Background: PubMed 19154469Krebs 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Scarberry, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELIEF Stent in people with Ureteral Obstruction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Bladder Irritation Symptoms (e.g. Frequency, Urgency, Nocturia, Urine Leakage...) Associated With the RELIEF Stent. (time frame: 24 hours post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266770, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.