Presented by: David Han MD,MS
Columbia University Irving Medical Center

Introduction

Histamine is a mast cell-derived mediator shown to be involved in ureteral peristalsis as well as bladder contraction, inflammation, and hypersensitivity. Given antihistamine’s use for symptom relief in bladder pain syndrome by potentially blocking mast cell activation, we evaluated the effect of antihistamine medication on ureteral stent-related symptoms.

Materials

We performed a double-blinded randomized controlled trial of adults undergoing unilateral ureteroscopy with stent placement for kidney/ureteral stone treatment. Patients with neurogenic bladder, chronic kidney disease, or urologic malignancy were excluded. Coloplast Imajin® silicone stents were used for all procedures. In addition to non-steroidal anti-inflammatory medications for post-operative pain control, patients were prescribed a 10-day course of either Fexofenadine 180mg oral daily (study arm) or placebo (control). Patients were prescribed breakthrough narcotic analgesia only as needed. Patients completed the Ureteric Stent Symptoms Questionnaire (USSQ) three times: pre-operatively without stent, with stent in situ immediately prior to stent removal, and post-stent at 4- to 6-week follow-up. Higher scores represented increasing symptom severity. The primary outcomes were differences in USSQ urinary symptom and pain scores immediately prior to stent removal, compared using Student’s t-test.

Results

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Of 64 patients (33 control and 31 study arm), mean age was 53 years and majority were men (58%). Mean stone burden (10mm) and mean time to stent removal (11 days) were similar between groups. With stent in situ, there were no differences in urinary symptom or pain scores between study arm and control groups (29 vs. 29, p=0.97 and 16 vs. 17, p=0.63; Figure); additionally, there were no differences between cohorts in any USSQ domain (p>0.05). There were no differences between study and control groups in mean duration of narcotic analgesia use (1 vs. 2 days, p=0.45), mean number of office phone calls for urinary symptoms (0.1 vs. 0.4, p=0.14), or number of Emergency Department visits (3 vs. 3, p=1.00). No patient experienced adverse drug events.

Conclusion

In an interim analysis at over 75% of target accrual, post-operative antihistamines were well-tolerated but did not reduce ureteral stent-related symptoms.

Funding

Coloplast – investigator-initiated trial.

Lead Authors

Ojas Shah, MD
Columbia University Irving Medical Center

Co-Authors

Ezra Margolin, MD
Columbia University Irving Medical Center

Miyad Movassaghi, MD
Columbia University Irving Medical Center

Jeffrey Johnson, MD
Weill Cornell Medical Center

Mahveesh Chowdhury, MPH
Columbia University Irving Medical Center

Srinath-Reddi Pingle, MD,MS
Columbia University Irving Medical Center

Ron Golan, MD
Sansum Clinic Urology

Michael Schulster, MD
Columbia University Irving Medical Center

David Weiner, MD
Columbia University Irving Medical Center