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Effect of Antihistamines on Ureteral Stent-Related Symptoms

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04726345
Enrollment
78
Registered
2021-01-27
Start date
2021-06-29
Completion date
2024-06-30
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrolithiasis

Keywords

Antihistamines, Ureteral stent

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.

Interventions

DRUGFexofenadine Hcl 180Mg Tab

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

DRUGPlacebo

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

Sponsors

Coloplast A/S
CollaboratorINDUSTRY
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
USSQ Urinary Symptom ScoreBaseline, 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.
USSQ Body Pain ScoreBaseline, 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.

Secondary

MeasureTime frameDescription
Quantity of Narcotic UseAfter 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 Office Phone Calls Due to Urinary Symptoms and PainAfter 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.
Number of Emergency Department VisitsAfter 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 EffectsAfter stent removal (1-2 weeks after surgery)This is to measure the morbidity of the study drug. Incidence will be self-reported by patients.
Duration of NSAID UseAfter stent removal (1-2 weeks after surgery)This is to measure morbidity associated with the indwelling ureteral stent. Duration will be reported in days.

Countries

United States

Participant flow

Participants by arm

ArmCount
Fexofenadine
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
37
Placebo
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
36
Total73

Baseline characteristics

CharacteristicFexofenadinePlaceboTotal
Age, Continuous53 years
STANDARD_DEVIATION 11
52 years
STANDARD_DEVIATION 15
53 years
STANDARD_DEVIATION 13
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants13 Participants31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants23 Participants42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Black
3 Participants3 Participants6 Participants
Race/Ethnicity, Customized
Hispanic or Latino
18 Participants13 Participants31 Participants
Race/Ethnicity, Customized
White
15 Participants20 Participants35 Participants
Region of Enrollment
United States
37 Participants36 Participants73 Participants
Sex: Female, Male
Female
14 Participants15 Participants29 Participants
Sex: Female, Male
Male
23 Participants21 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 36
other
Total, other adverse events
2 / 370 / 36
serious
Total, serious adverse events
0 / 370 / 36

Outcome results

Primary

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.

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

Population: 2 participants (1 in each Arm) were lost to follow-up

ArmMeasureGroupValue (MEAN)
FexofenadineUSSQ Body Pain Scorebaseline11 score on a scale
FexofenadineUSSQ Body Pain Scorestent in situ14 score on a scale
FexofenadineUSSQ Body Pain Scorefollow-up2 score on a scale
PlaceboUSSQ Body Pain Scorefollow-up4 score on a scale
PlaceboUSSQ Body Pain Scorebaseline11 score on a scale
PlaceboUSSQ Body Pain Scorestent in situ17 score on a scale
Primary

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.

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

Population: 2 participants (1 in each Arm) were lost to follow-up

ArmMeasureGroupValue (MEAN)
FexofenadineUSSQ Urinary Symptom Scorestent in situ28 score on a scale
FexofenadineUSSQ Urinary Symptom Scorefollow-up16 score on a scale
PlaceboUSSQ Urinary Symptom Scorefollow-up17 score on a scale
PlaceboUSSQ Urinary Symptom Scorestent in situ29 score on a scale
Secondary

Duration of NSAID Use

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

Time frame: After stent removal (1-2 weeks after surgery)

ArmMeasureValue (MEAN)Dispersion
FexofenadineDuration of NSAID Use3 daysStandard Deviation 3
PlaceboDuration of NSAID Use3 daysStandard Deviation 3
Secondary

Number of Drug-related Adverse Effects

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

Time frame: After stent removal (1-2 weeks after surgery)

ArmMeasureValue (NUMBER)
FexofenadineNumber of Drug-related Adverse Effects1 drug-related adverse effect
PlaceboNumber of Drug-related Adverse Effects0 drug-related adverse effect
Secondary

Number of Emergency Department Visits

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

Time frame: After stent removal (1-2 weeks after surgery)

ArmMeasureValue (NUMBER)
FexofenadineNumber of Emergency Department Visits2 emergency department visits
PlaceboNumber of Emergency Department Visits3 emergency department visits
Secondary

Number of Office Phone Calls Due to Urinary Symptoms and Pain

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.

Time frame: After stent removal (1-2 weeks after surgery)

ArmMeasureValue (NUMBER)
FexofenadineNumber of Office Phone Calls Due to Urinary Symptoms and Pain5 office phone calls
PlaceboNumber of Office Phone Calls Due to Urinary Symptoms and Pain9 office phone calls
Secondary

Quantity of Narcotic Use

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

Time frame: After stent removal (1-2 weeks after surgery)

ArmMeasureValue (MEAN)Dispersion
FexofenadineQuantity of Narcotic Use1 milligram morphine equivalentsStandard Deviation 5
PlaceboQuantity of Narcotic Use9 milligram morphine equivalentsStandard Deviation 50

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026