Effect of Antihistamines on Ureteral Stent-Related Symptoms
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|ClinicalTrials.gov Identifier: NCT04726345|
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : February 8, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Nephrolithiasis||Drug: Fexofenadine Hcl 180Mg Tab Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||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.|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Antihistamines on Ureteral Stent-Related Symptoms: Randomized Controlled Trial|
|Actual Study Start Date :||June 29, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
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 Name: Fexofenadine
Placebo Comparator: Placebo
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
Placebo tablet to be taken orally once a day until stent removal.
Other Name: Placebo Tablet
- Change in USSQ urinary symptom score [ Time Frame: At time of initial visit (prior to surgery - baseline), at time of stent removal (1-2 weeks after surgery), at time of follow-up (4-6 weeks after stent removal) ]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 11 questions. A sum of the total score can range from 11 to 54 points. High score indicates worse outcome.
- Change in USSQ body pain score [ Time Frame: At time of initial visit (prior to surgery - baseline), at time of stent removal (1-2 weeks after surgery), at time of follow-up (4-6 weeks after stent removal) ]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 7 questions. A sum of the total score can range from 6 to 37 points. High score indicates worse outcome.
- Number of office phone calls due to urinary symptoms and pain [ Time Frame: At time of 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.
- Duration of NSAID use [ Time Frame: At time of stent removal (1-2 weeks after surgery) ]This is to measure morbidity associated with the indwelling ureteral stent. Duration will be reported in days.
- Quantity of narcotic use [ Time Frame: At time of 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.
- Number of emergency department visits [ Time Frame: At time of 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.
- Number of drug-related adverse effects [ Time Frame: At time of stent removal (1-2 weeks after surgery) ]This is to measure the morbidity of the study drug. Incidence will be self-reported by patients.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726345
|Contact: Ezra J. Margolin, MDfirstname.lastname@example.org|
|United States, New York|
|Columbia University Irving Medical Center/NYP||Recruiting|
|New York, New York, United States, 10032|
|Contact: Ezra J. Margolin, MD 212-305-0114 email@example.com|
|Principal Investigator:||Ojas Shah, MD||Professor of Urology|
|Responsible Party:||Ojas Shah, George F. Cahill Professor of Urology, Columbia University|
|Other Study ID Numbers:||
|First Posted:||January 27, 2021 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Pathological Conditions, Anatomical
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Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs