search
Back to results

A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study

Primary Purpose

Urologic Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optitip Catheter (LinC Medical)
Foley catheter
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urologic Diseases focused on measuring Catheter, Pilot, Biofilm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Existing patients of Solent NHS Trust for > 3months
  • Capable of giving informed consent
  • Adult men or women (≥18)
  • Planning to be using a long-term catheter for the duration of the study (3 months)
  • Able to attend the clinic on the clinic/research days for catheter changes or have a research nurse visit them at home to do the changes
  • Willing to have the next 2 catheter changes at 4 weekly intervals, which may be different from their usual change interval

Exclusion Criteria:

  • Currently pregnant or planning to become pregnant
  • Lack of capacity to consent
  • Currently taking antibiotics for any reason (not just UTI) - unless the patient is usually on long term prophylactic antibiotics they may continue as long as they do so for the duration of the trial (unless instructed otherwise by a medical professional)
  • Taken antibiotics for any reason in the previous month
  • Has frequent catheter blockage ie. requiring catheter changes usually less than 4 weekly or visits for other catheter related reasons more frequently than 4 weekly
  • Planned bladder washouts of any frequency
  • Suprapubic catheter users
  • Those who need to visit a urology clinic due to complex catheter changes
  • Participation in a related study
  • Using a non-standard catheter e.g. not a Foley design
  • Using an unusual sized catheter - outside the sizes available (12-18F)
  • Unable to complete the assessments in English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    First standard Foley catheter than Optitip catheter

    First Optitip catheter than standard Foley catheter

    Arm Description

    Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Standard Foley catheter Study period 2 = Optitip catheter

    Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Optitip catheter Study period 2 = Standard Foley catheter

    Outcomes

    Primary Outcome Measures

    Number of blockage - accumulation of biofilm
    To compare the accumulation of biofilm on the catheter surface as a marker for the likelihood of blockage following 4 weeks insertion of an Optitip catheter to 4 weeks insertion of a standard Foley catheter. The 2 catheters (Foley and Optitip) will be collected and sent to the laboratory immediately after removal - the insertion period is 4 weeks + up to 7 days.

    Secondary Outcome Measures

    Participant completion of the validated quality of life tool - ICIQ-LTCqol.
    To determine whether there is any difference in patient reported quality of life score after using an Optitip catheter compared with a standard Foley catheter. Catheter function and concern 0-42 score, Lifestyle impact 0-15. Higher score better quality of life.
    Quantify microorganisms in the urine.
    Analysis of CSU for micro-organisms. To determine whether there is any difference in micro-organism in urine samples collected following the use of an Optitip catheter compared to a standard Foley catheter.
    Quantify cytokines in the urine.
    Analysis of CSU for cytokines. To determine whether there is any difference in cytokines in urine samples collected following the use of an Optitip catheter compared to a standard Foley catheter.

    Full Information

    First Posted
    April 21, 2020
    Last Updated
    December 28, 2021
    Sponsor
    University of Southampton
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04688541
    Brief Title
    A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
    Official Title
    A Preliminary Randomised Crossover Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Consequence of COVID-19 pandemic all staff working on this study were moved elsewhere and never returned to complete this work. Full RCT 'CADET' looking into Optitip use now taking place, so this pilot work is no longer required.
    Study Start Date
    April 1, 2020 (Actual)
    Primary Completion Date
    April 1, 2020 (Actual)
    Study Completion Date
    April 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Southampton

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study, long-term catheter patients in the Community setting (both catheter clinic attenders or home catheter changes) will be invited to participate in a randomised cross-over study to compare their standard Foley catheter with the Optitip catheter. The participants will be randomised to Arm A (Standard Foley catheter then Optitip) or Arm B (Optitip then Standard Foley catheter) and will have each catheter inserted for successive periods of 4 weeks (+ up to 7 days). The catheters will be collected following removal and analysed for presence of biofilm; catheter specimens of urine will also be collected to measure detection/quantity microorganisms and cytokines. The quality of life of participants will be assessed at baseline and the end of each study period using a validated quality of life tool for long-term catheter users - the ICIQ-LTCqol.
    Detailed Description
    When normal bladder emptying is not possible due to injury, disease, surgery, or neurological conditions, an indwelling urinary catheter (IUC) may be required. An estimated 90,000 people in the UK require a long-term urinary catheter. Urinary catheters are associated with significant harm and can cause substantial distress. Furthermore, managing frequent catheter-associated problems is a resource intensive burden to the providers of community healthcare services Currently, most patients use the standard Foley catheter design and experience problems that can constrain work and social lives, lead to UTI and pain and substantially reduce quality of life. The Optitip catheter became available on the Drug Tariff in 2017. Unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon. The Optitip therefore has the potential to make important differences to patients by reducing pain/discomfort; reducing blockage frequency and potentially reducing clinical infection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urologic Diseases
    Keywords
    Catheter, Pilot, Biofilm

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    First standard Foley catheter than Optitip catheter
    Arm Type
    Active Comparator
    Arm Description
    Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Standard Foley catheter Study period 2 = Optitip catheter
    Arm Title
    First Optitip catheter than standard Foley catheter
    Arm Type
    Active Comparator
    Arm Description
    Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Optitip catheter Study period 2 = Standard Foley catheter
    Intervention Type
    Device
    Intervention Name(s)
    Optitip Catheter (LinC Medical)
    Intervention Description
    The Optitip catheter, unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon.
    Intervention Type
    Device
    Intervention Name(s)
    Foley catheter
    Intervention Description
    Foley catheter
    Primary Outcome Measure Information:
    Title
    Number of blockage - accumulation of biofilm
    Description
    To compare the accumulation of biofilm on the catheter surface as a marker for the likelihood of blockage following 4 weeks insertion of an Optitip catheter to 4 weeks insertion of a standard Foley catheter. The 2 catheters (Foley and Optitip) will be collected and sent to the laboratory immediately after removal - the insertion period is 4 weeks + up to 7 days.
    Time Frame
    4 weeks + up to 7 days.
    Secondary Outcome Measure Information:
    Title
    Participant completion of the validated quality of life tool - ICIQ-LTCqol.
    Description
    To determine whether there is any difference in patient reported quality of life score after using an Optitip catheter compared with a standard Foley catheter. Catheter function and concern 0-42 score, Lifestyle impact 0-15. Higher score better quality of life.
    Time Frame
    56 days (+ up to 14 days)
    Title
    Quantify microorganisms in the urine.
    Description
    Analysis of CSU for micro-organisms. To determine whether there is any difference in micro-organism in urine samples collected following the use of an Optitip catheter compared to a standard Foley catheter.
    Time Frame
    56 days (+ up to 14 days)
    Title
    Quantify cytokines in the urine.
    Description
    Analysis of CSU for cytokines. To determine whether there is any difference in cytokines in urine samples collected following the use of an Optitip catheter compared to a standard Foley catheter.
    Time Frame
    56 days (+ up to 14 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Existing patients of Solent NHS Trust for > 3months Capable of giving informed consent Adult men or women (≥18) Planning to be using a long-term catheter for the duration of the study (3 months) Able to attend the clinic on the clinic/research days for catheter changes or have a research nurse visit them at home to do the changes Willing to have the next 2 catheter changes at 4 weekly intervals, which may be different from their usual change interval Exclusion Criteria: Currently pregnant or planning to become pregnant Lack of capacity to consent Currently taking antibiotics for any reason (not just UTI) - unless the patient is usually on long term prophylactic antibiotics they may continue as long as they do so for the duration of the trial (unless instructed otherwise by a medical professional) Taken antibiotics for any reason in the previous month Has frequent catheter blockage ie. requiring catheter changes usually less than 4 weekly or visits for other catheter related reasons more frequently than 4 weekly Planned bladder washouts of any frequency Suprapubic catheter users Those who need to visit a urology clinic due to complex catheter changes Participation in a related study Using a non-standard catheter e.g. not a Foley design Using an unusual sized catheter - outside the sizes available (12-18F) Unable to complete the assessments in English
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mandy Fader
    Organizational Affiliation
    University of Southampton
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    At all times throughout the study, confidentiality will be observed by all parties. All data shall be secured against unauthorised access whilst privacy and confidentiality of information about each participant shall be preserved in reports and any publication. Each participant will be assigned a unique identification number at the time of enrolment. The investigator will maintain a confidential study enrolment list. This will contain the unique assigned identification number and name. The investigator bears the responsibility of keeping this list confidential.

    Learn more about this trial

    A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study

    We'll reach out to this number within 24 hrs