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 range18 Years

SexALL

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

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