Phase 2
N=78
Effect of Antihistamines on Ureteral Stent-Related Symptoms
Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT04726345 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: USSQ Urinary Symptom Score — 28; 29; 16; 17 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fexofenadine Hcl 180Mg Tab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY USSQ Urinary Symptom Score |
28; 29; 16; 17 | — |
| PRIMARY USSQ Body Pain Score |
11; 11; 14; 17; 2; 4 | — |
| SECONDARY Number of Office Phone Calls Due to Urinary Symptoms and Pain |
5; 9 | — |
| SECONDARY Duration of NSAID Use |
3; 3 | — |
| SECONDARY Quantity of Narcotic Use |
1; 9 | — |
| SECONDARY Number of Emergency Department Visits |
2; 3 | — |
| SECONDARY Number of Drug-related Adverse Effects |
1; 0 | — |
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 ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones. Eligible patients will be randomly and divided into two groups in a 1:1 ratio. Group A will receive fexofenadine 180 mg once daily in addition to standard of care treatment. Group B will receive placebo in addition to standard of care treatment. The routine standard of care treatment will consist of oral non-steroidal anti-inflammatory drugs (NSAIDs).
The primary outcomes of the study are the Ureteral Stent Symptom Questionnaire (USSQ) urinary symptom score and pain score. Secondary outcomes include (i) number of office phone calls due to urinary symptoms; (ii) duration of analgesic use; (iii) duration and quantity of narcotic use; (iv) number of emergency department visits; (v) drug-related adverse effects; (vi) other domains of the USSQ.
Eligibility Criteria
Inclusion Criteria
- Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04726345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.