Suspended

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

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What is being tested

Optitip Catheter (LinC Medical)

+ Foley catheter

Device
Who is being recruted

Urogenital Diseases+2

+ Female Urogenital Diseases and Pregnancy Complications

+ Urologic Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: April 2020
See protocol details

Summary

Principal SponsorUniversity of Southampton
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleA Preliminary Randomised Crossover Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
NCT04688541
Principal SponsorUniversity of Southampton
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

6 inclusion criteria required to participate
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)

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12 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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

Group II

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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