Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities

Table 7

Adverse events related to the procedure/device.

Adverse events^i	n/N (%)	Events
Asymptomatic bacteriuria	25/107 (23.36%)	29
Pain	10/107 (9.35%)	10
Urinary urgency	8/107 (7.48%)	8
Urinary frequency	6/107 (5.61%)	6
Dysuria	6/107 (5.61%)	6
Voiding difficulty	6/107 (5.61%)	6
Hematuria	5/107 (4.67%)	5
Urinary incontinence	4/107 (3.74%)	5
Urinary retention	4/107 (3.74%)	5
Symptomatic urinary tract infection^ii	4/107 (3.74%)	6
Penile pain	3/107 (2.80%)	3
Residual urine	3/107 (2.80%)	3

Display of adverse events reported by 2% or more of all enrolled patients by MedDRA preferred code. (i) The following AEs were reported by less than 2% of the patients: urinalysis abnormal (2/107; 1.9%), bladder discomfort (1/107; 0.9%), calculus urinary bladder (1/107; 0.9%), cloudy urine (1/107; 0.9%), nocturia (1/107; 0.9%), painful erection (1/107; 0.9%), postvoid dribbling (1/107; 0.9%), and pus cells in urine (1/107; 0.9%). (ii) Symptomatic UTI definition based on then current CDC guidance. Urinary Tract Infection (Catheter-Associated Urinary Tract Infection (CAUTI) and Non-Catheter-Associated Urinary Tract Infection (UTI)) and Other Urinary System Infection (USI)) Events, January 2015.