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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Urologic Diseases
• Intervention / Treatment: Device: Optitip Catheter (LinC Medical); Device: Foley catheter

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First standard Foley catheter than 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 = Standard Foley catheter Study period 2 = Optitip catheter	Device: Optitip Catheter (LinC Medical); 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.; Device: Foley catheter; Foley catheter
Active Comparator: First Optitip catheter than standard Foley 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	Device: Optitip Catheter (LinC Medical); 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.; Device: Foley catheter; Foley catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks + up to 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	56 days (+ up to 14 days)
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.	56 days (+ up to 14 days)
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.	56 days (+ up to 14 days)

Collaborators and Investigators

• Sponsor: University of Southampton
• Investigators: Principal Investigator: Mandy Fader, University of Southampton

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Biofilm; Catheter; Pilot
• Additional Relevant MeSH Terms: Urologic Diseases
• Other Study ID Numbers: ERGO 53798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD 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.

Drug and device information, study documents

• 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