Effect of Antihistamines on Ureteral Stent-Related Symptoms

NCT ID: NCT04726345

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-29
• Study Completion Date: 2024-06-30

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.

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.

Conditions

Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Fexofenadine

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

Group Type: EXPERIMENTAL

Fexofenadine Hcl 180Mg Tab

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Fexofenadine Hcl 180Mg Tab

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Fexofenadine; Placebo Tablet

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Ojas Shah

George F. Cahill Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ojas Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Urology

Locations

Columbia University Irving Medical Center/NYP

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28467731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12576846 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12576847 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21453351 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19375088 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26393904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18849063 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39937815 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAT0219

Identifier Type: -

Identifier Source: org_study_id