Ureteral Stent Study

NCT03043612 | Completed

• 1 other identifier: 13-15
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis.

Conditions

Urolithiasis

Keywords

Ureteroscopy for urolithiasis

Outcome Measures

Primary Outcomes (1)

• Patient-reported body pain score

  Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms

  7-days post stent placement

Study Arms (2)

Ureteral Study Stent

EXPERIMENTAL

Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication

Device: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin

Ureteral Control Stent

ACTIVE COMPARATOR

Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent

Device: Cook Sof-Flex® Double Pigtail Ureteral Stent

Interventions

Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin DEVICE

Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis

Ureteral Study Stent

Cook Sof-Flex® Double Pigtail Ureteral Stent DEVICE

Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis

Ureteral Control Stent

Eligibility Criteria

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

You may qualify if:

• Patient is undergoing ureteroscopy for urolithiasis in which temporary ureteral stenting is indicated

You may not qualify if:

• Patient is unwilling or unable to sign and date the informed consent
• Patient is unwilling to comply with the follow-up study schedule
• Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
• Patient is currently taking anti-cholinergic or other anti-spasm medications
• Patient is currently taking sildenafil, tadalafil, or vardenafil
• Patient has a known sensitivity to alpha-blocker medications
• Patient is currently undergoing chemotherapy or radiation therapy
• Patient has an active urinary tract infection
• Patient is in chronic renal failure, on hemodialysis, or on chronic peritoneal dialysis
• Patient requires bilateral shock wave lithotripsy, bilateral stents, or has bilateral symptomatic kidney stones
• Patient has had a ureteral stent within the past three months in either ureter
• Patient is unable to accurately detect or report bladder function or pain
• Patient has chronic pain

Sponsors & Collaborators

• Cook Group Incorporated: lead

Study Sites (1)

Prince of Wales/Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Chi-Fai Ng

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 6, 2017
• Study Start: June 10, 2015
• Primary Completion: June 16, 2017
• Study Completion: June 30, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)