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

May 5, 2011 updated by: Lahey Clinic
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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Outpatients from Lahey Clinic Urology Service and colleague referrals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahey Clinic

Collaborators

Spirus Medical, Inc.

Investigators

  • Principal Investigator: John T. Stoffel, M.D., Lahey Clinic, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (ESTIMATE)

December 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2011

Last Update Submitted That Met QC Criteria

May 5, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Retention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe