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

This study has been terminated.
(pending design changes to the device)
Sponsor:
Collaborator:
Spirus Medical, Inc.
Information provided by:
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00804557
First received: December 5, 2008
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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.


Condition
Urinary Retention
Urinary Catheterization

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: October 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Uro-Ease Spirus Catheter
10 patients randomized to the Uro-Ease Catheter group for 1 week. In clinic, patients will be instructed in the use of the Uro-Ease Catheter. A QOL form will be filled out measuring comfort and ease of use and subsequently after each catheterization. Patients will also record time per catheterization and bladder drainage. Patients will return to Clinic in 1 week to check progress and will then change to a standard, non-helical urinary catheter. Patients will be followed up to 1 month.
Standard Urinary Catheter
10 patients randomized to a Standard Urinary Catheter group for 1 week. In clinic, patients will be instructed in the use of the catheter. A QOL form will be filled out measuring comfort and ease of use and subsequently after each catheterization. Patients will also record time per catheterization and bladder drainage. Patients will return to Clinic in 1 week to check progress and will then change to the UroEase Spirus Catheter. All patients will be followed up to 1 month.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients from Lahey Clinic Urology Service and colleague referrals

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804557

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Spirus Medical, Inc.
Investigators
Principal Investigator: John T. Stoffel, M.D. Lahey Clinic, Inc.
  More Information

Publications:

Responsible Party: John T. Stoffel, M.D., Lahey Clinic, Inc.
ClinicalTrials.gov Identifier: NCT00804557     History of Changes
Other Study ID Numbers: 2008-065
Study First Received: December 5, 2008
Last Updated: May 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Male Urinary Disorders
Urinary catheterization
Urinary retention

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014