NCT04688541

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urologic Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-04-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2020-12-30
• Last updated: 2022-01-14