Effect of Antihistamines on Ureteral Stent-Related Symptoms

July 14, 2025 updated by: Ojas Shah, Columbia University

Effect of Antihistamines on Ureteral Stent-Related Symptoms: Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 injury. These stents are routinely utilized after urologic procedures for the treatment of urolithiasis and are generally kept in place for 1-2 weeks following the procedure. Despite their advantages, indwelling ureteral stents cause discomfort and reduce patient quality of life. These symptoms are partially attributed to local irritation to the ureter and bladder. Bothersome stent-related symptoms include urinary urgency, frequency, flank pain, hematuria, dysuria, sexual side effects, and emotional distress. The majority of patients with ureteral stents experience symptoms post-operatively.

Several studies have indicated that agents such as antimuscarinics or alpha-1 adrenergic receptor antagonists may improve stent-related symptoms. The indications for anticholinergic medications are based on blocking involuntary bladder muscle contraction; however, the efficacy of these drugs is still controversial. Furthermore, these medications have potential adverse side effects.

Antihistamines also show potential in alleviating stent-related symptoms. Multiple in vitro studies have shown H1 receptor activity involved both in ureteral peristalsis and in bladder contraction. Both first- and second-generation H1 antagonists have shown activity in the urinary tract. In clinical practice, antihistamines are commonly utilized in the management of bladder pain caused by interstitial cystitis. Additionally, a randomized controlled trial found efficacy of antihistamines for pain management in the setting of renal colic from obstructing ureteral stones. There is novel evidence that in patients with indwelling stents, there are inflammatory changes in the bladder with an associated eosinophilic reaction. Eosinophilic cystitis is commonly associated with bladder irritation or allergy, and these findings point to a novel paradigm of treating patients with antihistamines. To our knowledge, no studies have evaluated the efficacy of antihistamines for managing stent-related symptoms.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center/NYP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fexofenadine
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
Drug: Fexofenadine Hcl 180Mg Tab
Fexofenadine 180mg tablet to be taken orally once a day until stent removal.
Other Names:
  • Fexofenadine
Placebo Comparator: Placebo
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
Drug: Placebo
Placebo tablet to be taken orally once a day until stent removal.
Other Names:
  • Placebo Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
USSQ Urinary Symptom Score
Time Frame: 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.
Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)
USSQ Body Pain Score
Time Frame: 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, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Office Phone Calls Due to Urinary Symptoms and Pain
Time Frame: 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.
After stent removal (1-2 weeks after surgery)
Duration of NSAID Use
Time Frame: 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.
After stent removal (1-2 weeks after surgery)
Quantity of Narcotic Use
Time Frame: 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.
After stent removal (1-2 weeks after surgery)
Number of Emergency Department Visits
Time Frame: 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.
After stent removal (1-2 weeks after surgery)
Number of Drug-related Adverse Effects
Time Frame: 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.
After stent removal (1-2 weeks after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Coloplast A/S

Investigators

  • Principal Investigator: Ojas Shah, MD, Professor of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2021

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT0219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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