NCT04726345

Effect of Antihistamines on Ureteral Stent-Related Symptoms

Completed Phase 2 Results posted Last updated 16 July 2025

What this trial tests

Phase 2 trial testing Fexofenadine Hcl 180Mg Tab in Nephrolithiasis in 78 participants. Completed in 30 June 2024.

Timeline

29 June 2021

Primary endpoint
30 June 2024

30 June 2024

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	78
Start date	29 June 2021
Primary completion	30 June 2024
Estimated completion	30 June 2024
Sites	1 location across United States

Drugs / interventions tested

• Fexofenadine Hcl 180Mg Tab — full drug profile →
• Placebo

Conditions studied

• Nephrolithiasis — all drugs for Nephrolithiasis →

Sponsor

Columbia University

Who can join

Adults 18 to 80, any sex, with Nephrolithiasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

USSQ Urinary Symptom Score Primary · Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)

Ureteric Stent Symptoms Questionnaire (USSQ) is a self-administered questionnaire to evaluate the overall impact of ureteral stents on different aspects of life. Urinary symptom will be assessed at different time points. The urinary symptom section consists of 11 questions. The total score range is 11 to 54 points. Higher scores represent increasing symptom severity.

stent in situ

Group	Value	95% CI
Fexofenadine	28	26 – 31
Placebo	29	26 – 31

follow-up

Group	Value	95% CI
Fexofenadine	16	15 – 18
Placebo	17	15 – 18

USSQ Body Pain Score Primary · Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)

Ureteric Stent Symptoms Questionnaire (USSQ) is a self-administered questionnaire to evaluate the overall impact of ureteral stents on different aspects of life. Body pain will be assessed at different time points. The body pain section consists of 7 questions. The total score range is 0 to 37 points. Higher scores represent increasing pain.

baseline

Group	Value	95% CI
Fexofenadine	11	7 – 14
Placebo	11	8 – 15

stent in situ

Group	Value	95% CI
Fexofenadine	14	10 – 18
Placebo	17	13 – 21

follow-up

Group	Value	95% CI
Fexofenadine	2	0 – 4
Placebo	4	1 – 6

Number of Office Phone Calls Due to Urinary Symptoms and Pain Secondary · After stent removal (1-2 weeks after surgery)

This is to measure the morbidity associated with the indwelling ureteral stent. Urinary symptoms will include urinary frequency, urgency, incontinence, nocturia, incomplete emptying, dysuria, and hematuria. Total number of calls per group are reported.

Group	Value	95% CI
Fexofenadine	5
Placebo	9

Duration of NSAID Use Secondary · After stent removal (1-2 weeks after surgery)

This is to measure morbidity associated with the indwelling ureteral stent. Duration will be reported in days.

Group	Value	95% CI
Fexofenadine	3	± 3
Placebo	3	± 3

Quantity of Narcotic Use Secondary · After stent removal (1-2 weeks after surgery)

This is to measure the morbidity associated with the indwelling ureteral stent. It will be reported in milligram morphine equivalents.

Group	Value	95% CI
Fexofenadine	1	± 5
Placebo	9	± 50

Number of Emergency Department Visits Secondary · After stent removal (1-2 weeks after surgery)

This is to measure morbidity associated with the indwelling ureteral stent. Incidence will be collected at study visit.

Group	Value	95% CI
Fexofenadine	2
Placebo	3

Number of Drug-related Adverse Effects Secondary · After stent removal (1-2 weeks after surgery)

This is to measure the morbidity of the study drug. Incidence will be self-reported by patients.

Group	Value	95% CI
Fexofenadine	1
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Postoperatively, 1-2 weeks after surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fexofenadine

Serious: 0/37 (0%)

Deaths: 0/37

Placebo

Serious: 0/36 (0%)

Deaths: 0/36

Other adverse events (2 terms — click to expand)

Reaction	System	Fexofenadine	Placebo
Dizziness	General disorders	—	—
UTI	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04726345 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.