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

NCT03266770 | Completed Results DMC FDA Device

• 1 other identifier: 04-17-30
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Obstruction

Keywords

ureteral stent

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Incidence of RELIEF Stent-Related Adverse Events

  0-30 days.

Study Arms (1)

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.

Device: RELIEF Stent

Interventions

RELIEF Stent DEVICE

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).

RELIEF stent placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with distal ureteral obstruction
• Patients with urinary reflux
• Patients requiring bilateral surgical stone management procedure

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (6)

• 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.

  PMID: 15075840 BACKGROUND

• 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.

  PMID: 11927301 BACKGROUND

• 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.

  PMID: 17069037 BACKGROUND

• 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.

  PMID: 19513705 BACKGROUND

• 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.

  PMID: 20590539 BACKGROUND

• 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.

  PMID: 19154469 BACKGROUND

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Kyle Scarberry
• Organization: University Hospitals Cleveland Medical Center

Kyle.Scarberry@UHhospitals.org

(216)844-3009

Study Officials

• Kyle Scarberry, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Urology

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 30, 2017
• Study Start: June 15, 2021
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)