Trial Outcomes & Findings for Effect of Antihistamines on Ureteral Stent-Related Symptoms (NCT NCT04726345)
NCT ID: NCT04726345
Last Updated: 2025-07-16
Results Overview
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.
COMPLETED
PHASE2
78 participants
Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)
2025-07-16
Participant Flow
Participant milestones
| Measure |
Fexofenadine
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
Baseline Analysis
STARTED
|
39
|
39
|
|
Baseline Analysis
COMPLETED
|
37
|
36
|
|
Baseline Analysis
NOT COMPLETED
|
2
|
3
|
|
Stent in Situ
STARTED
|
37
|
36
|
|
Stent in Situ
COMPLETED
|
35
|
36
|
|
Stent in Situ
NOT COMPLETED
|
2
|
0
|
|
Post-stent Removal Follow-up (4-6 Weeks)
STARTED
|
35
|
36
|
|
Post-stent Removal Follow-up (4-6 Weeks)
COMPLETED
|
34
|
35
|
|
Post-stent Removal Follow-up (4-6 Weeks)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Antihistamines on Ureteral Stent-Related Symptoms
Baseline characteristics by cohort
| Measure |
Fexofenadine
n=37 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 11 • n=5 Participants
|
52 years
STANDARD_DEVIATION 15 • n=7 Participants
|
53 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Fexofenadine
n=35 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
USSQ Urinary Symptom Score
stent in situ
|
28 score on a scale
Interval 26.0 to 31.0
|
29 score on a scale
Interval 26.0 to 31.0
|
|
USSQ Urinary Symptom Score
follow-up
|
16 score on a scale
Interval 15.0 to 18.0
|
17 score on a scale
Interval 15.0 to 18.0
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Fexofenadine
n=35 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
USSQ Body Pain Score
baseline
|
11 score on a scale
Interval 7.0 to 14.0
|
11 score on a scale
Interval 8.0 to 15.0
|
|
USSQ Body Pain Score
stent in situ
|
14 score on a scale
Interval 10.0 to 18.0
|
17 score on a scale
Interval 13.0 to 21.0
|
|
USSQ Body Pain Score
follow-up
|
2 score on a scale
Interval 0.0 to 4.0
|
4 score on a scale
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fexofenadine
n=37 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
Number of Office Phone Calls Due to Urinary Symptoms and Pain
|
5 office phone calls
|
9 office phone calls
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fexofenadine
n=37 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
Duration of NSAID Use
|
3 days
Standard Deviation 3
|
3 days
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fexofenadine
n=37 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
Quantity of Narcotic Use
|
1 milligram morphine equivalents
Standard Deviation 5
|
9 milligram morphine equivalents
Standard Deviation 50
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fexofenadine
n=37 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
Number of Emergency Department Visits
|
2 emergency department visits
|
3 emergency department visits
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fexofenadine
n=37 Participants
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 Participants
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
Number of Drug-related Adverse Effects
|
1 drug-related adverse effect
|
0 drug-related adverse effect
|
Adverse Events
Fexofenadine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fexofenadine
n=37 participants at risk
Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs).
|
Placebo
n=36 participants at risk
Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs).
|
|---|---|---|
|
General disorders
Dizziness
|
2.7%
1/37 • Postoperatively, 1-2 weeks after surgery
|
0.00%
0/36 • Postoperatively, 1-2 weeks after surgery
|
|
Infections and infestations
UTI
|
2.7%
1/37 • Postoperatively, 1-2 weeks after surgery
|
0.00%
0/36 • Postoperatively, 1-2 weeks after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place