Ureteral Obstruction Clinical Trial
Official title:
The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux and Distal Coil Bladder Position
Verified date | January 2024 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 12, 2022 |
Est. primary completion date | December 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. doi: 10.1016/s0090-4295(01)01644-2. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 hours post op | |
Primary | 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. | Baseline, Day 30 | |
Secondary | 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. | 0-30 days. |
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