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

Table 1

Study activities.

Activity	Screening, catheter cessation, enrollment, 1st Spanner placement	Follow-up visit after 1^st month of Spanner use	Follow-up visit after 2^nd month of Spanner use	Follow-up visit after 3^rd month of Spanner use	Follow-up phone call
Informed consent	●
Medical history^i, physical, digital rectal exam	●
Concomitant medication assessment	●	●	●	●
Urinalysis	●	●	●	●
Catheterization assessment	●				●
Cystoscopy	●			●
Eligibility assessment	●
Study enrollment	●
Surveyor measurement	●
Stent placement	●	●	●
Stent removal		●	●	●
Adverse event assessment^i, ii	●	●	●	●	●
Uroflowmetry and post void residual	●	●	●	●
Satisfaction questionnaire	●	●	●	●
Serum creatinine	●	●	●	●
International prostate symptom score including quality of life^iii		●	●	●
End of study					●

List of study activities conducted at each visit. Visit 1 included consent, assessment of selection criteria, enrollment, placement of first stent, and measurement of PVR with The Spanner in situ. The Spanner was exchanged at each of the next three study visits for a total of 90 days of stent use. Study ended after the final follow-up phone call to assess patient safety. (i) Medical History coded to MedDRA System Organ Class. AEs and SAEs were coded to preferred terms. (ii) Symptomatic UTI definition based on the 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. (iii) Symptom Assessment based on AUA Symptom Score/IPSS as published by Barry et al. [11] and by Cockett et al. [12].