Clinical trial NCT00804557: Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization
Official title: Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urinary Retention
Urinary Catheterization
Keywords: Male Urinary Disorders
Urinary catheterization
Urinary retention
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: Spirus Medical, Inc.
First posted: 2008-12-09
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients from Lahey Clinic Urology Service and colleague referrals

Brief summary: To evaluate the ease of use and comfort of a new urinary catheter, the Uro-Ease, as used in the Clean Intermittent Catheterization (CIC)process.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male patients
* Urinary retention defined as \>150cc retained in bladder on post void residual

Exclusion Criteria:

* Female patients
* Known urethral stricture
* Active symptomatic Urinary Tract Infection
* History of pelvic fracture or urethral disruption
* History of previous urethroplasty(urethral reconstructive surgery)
* Known Latex allergy
* Unable to physically perform CIC
* Unable to provide follow up
* Unable to give consent
* Currently taking chronic narcotic pain medication

Primary outcomes:
measure: To determine whether the design of the Uro-Ease Catheter device allows for easier, more comfortable clean intermittent self-catheterization (CIC) while maintaining safe bladder drainage. Using Visual Analog Scales and Timed procedure logs
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: John T. Stoffel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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