Effect of Antihistamines on Ureteral Stent-Related Symptoms

NCT04726345 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AAAT0219
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Nephrolithiasis

Keywords

Antihistamines; Ureteral stent

Outcome Measures

Primary Outcomes (2)

• USSQ Urinary Symptom Score

  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.

  Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)

• USSQ Body Pain Score

  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, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)

Secondary Outcomes (5)

• Number of Office Phone Calls Due to Urinary Symptoms and Pain

  After stent removal (1-2 weeks after surgery)

• Duration of NSAID Use

  After stent removal (1-2 weeks after surgery)

• Quantity of Narcotic Use

  After stent removal (1-2 weeks after surgery)

• Number of Emergency Department Visits

  After stent removal (1-2 weeks after surgery)

• Number of Drug-related Adverse Effects

  After stent removal (1-2 weeks after surgery)

Study Arms (2)

Fexofenadine

EXPERIMENTAL

Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).

Drug: Fexofenadine Hcl 180Mg Tab

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).

Drug: Placebo

Interventions

Fexofenadine Hcl 180Mg Tab DRUG

Fexofenadine 180mg tablet to be taken orally once a day until stent removal.

Also known as: Fexofenadine

Fexofenadine

Placebo DRUG

Placebo tablet to be taken orally once a day until stent removal.

Also known as: Placebo Tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• Coloplast A/S: collaborator

Study Sites (1)

Columbia University Irving Medical Center/NYP

New York, New York, 10032, United States

Location

Related Publications (8)

• Aboutaleb H, Gawish M. Correlation of Bladder Histopathologic Changes Due to Double-J Stenting to the Period of Stenting: A Preliminary Study. J Endourol. 2017 Jul;31(7):705-710. doi: 10.1089/end.2017.0113. Epub 2017 May 31.

  PMID: 28467731 BACKGROUND

• Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.

  PMID: 12576846 BACKGROUND

• Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.

  PMID: 12576847 BACKGROUND

• Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.

  PMID: 21453351 BACKGROUND

• Lingeman JE, Preminger GM, Goldfischer ER, Krambeck AE; Comfort Study Team. Assessing the impact of ureteral stent design on patient comfort. J Urol. 2009 Jun;181(6):2581-7. doi: 10.1016/j.juro.2009.02.019. Epub 2009 Apr 16.

  PMID: 19375088 BACKGROUND

• Sivalingam S, Streeper NM, Sehgal PD, Sninsky BC, Best SL, Nakada SY. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial. J Urol. 2016 Feb;195(2):385-90. doi: 10.1016/j.juro.2015.08.104. Epub 2015 Sep 21.

  PMID: 26393904 BACKGROUND

• Yilmaz E, Batislam E, Deniz T, Yuvanc E. Histamine 1 receptor antagonist in symptomatic treatment of renal colic accompanied by nausea: two birds with one stone? Urology. 2009 Jan;73(1):32-6. doi: 10.1016/j.urology.2008.08.494. Epub 2008 Oct 11.

  PMID: 18849063 BACKGROUND

• Han DS, Margolin EJ, Movassaghi M, Johnson JP, Chowdhury M, Pingle SR, Schulster ML, Weiner DM, Shah O. Effect of Antihistamine on Ureteral Stent-Related Symptoms: A Double-Blind Randomized Controlled Trial. Urol Pract. 2025 Jul;12(4):415-425. doi: 10.1097/UPJ.0000000000000791. Epub 2025 Feb 12.

  PMID: 39937815 DERIVED

MeSH Terms

Conditions

Nephrolithiasis

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Results Point of Contact

• Title: Ezra J. Margolin, MD
• Organization: Columbia University

ejm2182@cumc.columbia.edu

212-305-0114

Study Officials

• Ojas Shah, MD

  Professor of Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Subjects and the study urologist will be blinded to treatment allocation. Treatment allocation will be known by the investigator performing data analysis, who will not be directly participating in patient care.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: George F. Cahill Professor of Urology

Model Details: Subjects will be randomized in a 1:1 ratio to receive fexofenadine or placebo in addition to the standard of care. A total of 39 subjects will be randomized to each group.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 27, 2021
• Study Start: June 29, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)