Urolithiasis Clinical Trial
Official title:
Cook Ureteral Stent Study
Verified date | June 2017 |
Source | Cook Group Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 16, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales/Chinese University of Hong Kong | Sha Tin |
Lead Sponsor | Collaborator |
---|---|
Cook Group Incorporated |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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