Migration of Intraureteral Stents Compared to Conventional Double-J Stents.

NCT04763837 | Withdrawn FDA Device

• 1 other identifier: 20.0563
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if stents placed with only one loop in the kidney move more than stents placed with a loop in both the kidney and a bladder. Participants in this study will undergo placement of a stent into the ureter that drains urine from the kidney into the bladder. The stent will be placed in 1 of 2 ways: either with only a loop of the stent is left in the kidney or in the regular manner where a loop of the stent is left in both the kidney and in the bladder. The position of the stent will be measured at the time of placement. When the stent is removed, the position of the stent will be measured prior to pulling the stent.

Conditions

Urologic Diseases; Urological System Complication of Procedure

Keywords

urology; ureteral stent

Outcome Measures

Primary Outcomes (1)

• Stent migration

  The distance that the stent migrates into the bladder or into the kidney.

  12 months

Secondary Outcomes (1)

• Patient comfort level

  12 months

Study Arms (2)

Intraureteral stent group

EXPERIMENTAL

Patients assigned to this group will undergo placement of an intraureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in only in the kidney and NOT in the bladder. This group will be the experimental group.

Device: Intraureteral stent

Conventional Double-J stent

ACTIVE COMPARATOR

Patients assigned to this group will undergo placement of a double-J ureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in both the kidney and the bladder. This group will serve as the control.

Device: Conventional Double-J stent

Interventions

Intraureteral stent DEVICE

This intervention involves the placement of an intraureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube only in the kidney and NOT in the bladder. The distal end of the tube will stay in the ureter just proximal to the opening to the bladder.

Also known as: Polaris™ Loop Ureteral Stent - Boston Scientific

Intraureteral stent group

Conventional Double-J stent DEVICE

This intervention involves the placement of a conventional double-J stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in both the kidney and in the bladder.

Conventional Double-J stent

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Those undergoing ureteral stent placement for nephrolithiasis, hydronephrosis, and urological cancer.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Louisville: lead

Related Publications (5)

• Finney RP. Experience with new double J ureteral catheter stent. 1978. J Urol. 2002 Feb;167(2 Pt 2):1135-8; discussion 1139. doi: 10.1016/s0022-5347(02)80361-5. No abstract available.

  PMID: 11905888 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

• Pollard SG, Macfarlane R. Symptoms arising from Double-J ureteral stents. J Urol. 1988 Jan;139(1):37-8. doi: 10.1016/s0022-5347(17)42282-8.

  PMID: 2961892 BACKGROUND

• Yoshida T, Inoue T, Taguchi M, Matsuzaki T, Murota T, Kinoshita H, Matsuda T. Efficacy and Safety of Complete Intraureteral Stent Placement versus Conventional Stent Placement in Relieving Ureteral Stent Related Symptoms: A Randomized, Prospective, Single Blind, Multicenter Clinical Trial. J Urol. 2019 Jul;202(1):164-170. doi: 10.1097/JU.0000000000000196. Epub 2019 Jun 7.

  PMID: 30829132 BACKGROUND

• Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.

  PMID: 12576846 BACKGROUND

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Kellen B Choi, DO, FACOS

  Associate Professor, University of Louisville Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will not be informed of which type of ureteral stent will be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor

Model Details: This study will be a prospective, randomized controlled, single-blinded trial. The subjects will include up to 140 patients (about 70 subjects per group) from ages 1-100 years old that are to undergo stent placement for nephrolithiasis, hydronephrosis, and urological cancer. They will be randomized to one of two groups: intraureteral stent or conventional double-J stent. Upon removal of the stent, migration distance will be measured via fluoroscopy using a calibrated x-ray system.

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 21, 2021
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 29, 2022

Record last verified: 2022-04