WithdrawnNot Applicable

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

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.

0Started 2020-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of blockage - accumulation of biofilm

Timeframe: 4 weeks + up to 7 days.

Trial details

NCT IDNCT04688541

SponsorUniversity of Southampton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-01

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