Clinical trial NCT04688541: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Urologic Diseases
Keywords: Catheter
Pilot
Biofilm
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of blockage - accumulation of biofilm
timeFrame: 4 weeks + up to 7 days.
Secondary outcomes:
measure: Participant completion of the validated quality of life tool - ICIQ-LTCqol.
timeFrame: 56 days (+ up to 14 days)
measure: Quantify microorganisms in the urine.
timeFrame: 56 days (+ up to 14 days)
measure: Quantify cytokines in the urine.
timeFrame: 56 days (+ up to 14 days)
Other outcomes:
Locations:
Study officials:
affiliation: University of Southampton
name: Mandy Fader
role: PRINCIPAL_INVESTIGATOR
References: