T-DOC® 5 Fr Pediatric Clinical Investigation

A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects

A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects

Inclusion Criteria:

• Male and Female (Children and infants, 12 years of age and younger)
• Subjects who are scheduled and normally indicated for urodynamics testing, for any medically necessary reason as per the physician.

Exclusion Criteria:

• Subjects who suffer from bladder infections (not including subjects with asymptomatic bacteruria)
• Subjects with urethral strictures
• Subjects who require the use of a suprapubic catheter