Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization

Urinary retention can occur among men with Benign Prostatic Hypertrophy(BPH) or Neurologic
co-morbidities.

Many of these men are treated with Clean Intermittent Catheterization(CIC. For some, this
can be a time consuming and often painful process due to difficulty with catheter insertion
and manipulation, which may result in urethral injury or non-compliance.

The blunt nose of a standard catheter can meet significant resistance at the external
sphincter or within the prostate urethra. Spirus Medical has developed a urinary catheter,
Uro-Ease, with a rounded helical thread formed on the surface of its distal end for use in
CIC.

This study is to determine whether the design of the Uro-Ease catheter allows for easier
Clean Intermittent self-Catheterization(CIC) while maintaining safe bladder drainage.

This is a prospective randomized study with two phases.

Phase 1: Observational, 5 patients. In this phase, five patients meeting the inclusion
criteria will be consented from the Urology Clinic. Participating Urology nurses who have
been previously trained in the utilization of the Spirus Catheter, will perform the initial
CIC on the patient with a 12 Fr Spirus Catheter(choice of 2 different flexibilities). The
study nurse will document time per catheterization and effective drainage of bladder. Before
leaving the clinic, patient's will be instructed in the use of the Spirus Catheter and
demonstrate efficacy with using the Spirus Catheter. Patients will then fill out VAS Forms
for ease and comfort of catheter insertion and after each subsequent catheterization.
Patients will also record, for 3 consecutive days, time it takes for catheterization and
time to drain the bladder . Patients will return to clinic in 1 week to return VAS forms and
documentation. A follow-up phone call will be made to the patient in month to check on
patient's status.

All patients will be instructed to call clinic, nurse or on-call-urologist for any report of
urethral trauma, which will be evaluated with flexible cystoscopy. These reports will be
reviewed and documented.

Phase 2: Randomized crossover trial, 20 patients. After successful completion of Phase 1,
patients will be randomized into 2 groups-10 patients will first be randomized into the
Spirus Catheter Group and 10 patients into the Standard 12 FR Bard Catheter Group.(Coude' or
straight catheters may be utilized for standard group) As in Phase 1, all patients will
receive CIC instruction for self-catheterization, specific to the selected catheter and can
demonstrate efficacy with CIC using selected catheter, before they leave the clinic.
Patients will then fill out VAS forms for catheter insertion ease and comfort and after each
subsequent catheterization. Patient will also record time per catheterization and bladder
drainage for 3 consecutive days. Patients will return to the clinic in 1 week for a progress
report, return VAS forms and reports. At this time the patient will be switch over to the
alternate catheter group for 1 week.

All patients will be instructed to call clinic, nurse or on-call-urologist for any report of
urethral trauma, defined as blood on catheter or per meatus. Any occurence of urethral
trauma will be evaluated with flexible cystoscopy. These reports will be reviewed and
documented.

All patients will be followed up to one month to check on the patient's status.