Cook Ureteral Stent Study

Ureteral Stent Study

Sponsors

Lead sponsor: Cook Group Incorporated

Source Cook Group Incorporated
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.

Overall Status Completed
Start Date June 10, 2015
Completion Date June 30, 2017
Primary Completion Date June 16, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patient-reported body pain score 7-days post stent placement
Enrollment 56
Condition
Intervention

Intervention type: Device

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

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

Arm group label: Ureteral Study Stent

Intervention type: Device

Intervention name: Cook Sof-Flex® Double Pigtail Ureteral Stent

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

Arm group label: Ureteral Control Stent

Eligibility

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Chi-Fai Ng Principal Investigator Prince of Wales Hospital
Location
facility
Prince of Wales/Chinese University of Hong Kong
Location Countries

Hong Kong

Verification Date

June 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Ureteral Study Stent

Arm group type: Experimental

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

Arm group label: Ureteral Control Stent

Arm group type: Active Comparator

Description: Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Device Feasibility

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov