Status:
COMPLETED
Effect of Antihistamines on Ureteral Stent-Related Symptoms
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Coloplast A/S
Conditions:
Nephrolithiasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscop...
Detailed Description
Ureteral stents treat ureteral obstruction, allow for passive dilation of the ureter, maintain urine flow to the bladder, and aid in the recovery of the ureter after endoscopic surgery or ureteral inj...
Eligibility Criteria
Inclusion
- Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones
Exclusion
- Preoperative use of antihistamines, beta-3 agonists, anticholinergics, corticosteroids, and chronic opioid analgesic use
- Preoperative indwelling ureteral stent at the time of treatment
- Neurogenic bladder, ureteral stricture, interstitial cystitis, or chronic prostatitis
- Pregnancy or breastfeeding
- Planned bilateral ureteroscopy
- Solitary or transplanted kidney
- Hypersensitivity to antihistamines
- Severe renal disease (glomerular filtration rate (GFR) \< 10 ml/min or on dialysis)
- Significant deviation in operative plan (ureteral stent not deemed necessary, incidental urologic malignancy, tandem ureteral stent placement, second-stage procedure required)
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04726345
Start Date
June 29 2021
End Date
June 30 2024
Last Update
July 16 2025
Active Locations (1)
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1
Columbia University Irving Medical Center/NYP
New York, New York, United States, 10032