Status:
WITHDRAWN
A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
Lead Sponsor:
University of Southampton
Conditions:
Urologic Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 req...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04688541
Start Date
April 1 2020
End Date
April 1 2020
Last Update
January 14 2022
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