A non-inferiority randomised controlled trial to compare mixed (multi/single-use) catheter management with single-use catheter management by intermittent catheter users over 12 months
Urinary tract infection
Current intervention as of 22/07/2022: The researchers hope to recruit 578 participants who are carrying out intermittent catheterisation from around the UK. 50% of these participants will be randomised to using single-use catheters (usual care) with the other half randomised to the mixed-use strategy whereby participants will use a combination of single-use and multi-use catheters for 12 months. Participants in the mixed-use arm will use a reusable silicone catheter which CE marked for reuse for some of their intermittent catheterisation. ). Randomisation will be administered centrally by a secure web-based randomisation system. Permuted random blocks of variable length will be used to allocate participants 1:1 to the mixed-use and single-use only groups. Participants who consent and are randomised to the trial will be asked to complete a series of questionnaires about their catheter use and any urinary tract infections (UTIs) experienced over the course of the trial in addition to their general health. Participants will also be required to provide regular urine specimens at specific time points and anytime the participant suspects a UTI. Schedule of Events Visit 1- Screening and baseline (face to face visit): - Written informed consent from participant taken by appropriately delegated member of the research team. - Eligibility confirmed and documented. - Baseline activities completed- patient medical history taken, concomitant medication, baseline and randomisation CRF completed, Barthel index calculated and EQ-5D-5L completed. -Urine sample taken and sent to central laboratory - Participant randomisation to single-use IC or mixed-use IC strategy. Revisions to the protocol have been made, to minimise face-to-face contact - the patient can choose to receive the informed consent form by post, the kit is then posted to the participant and instructions/guidance are given, and monthly contacts carried out, by phone or videoconference. Two-week learning period: Pa
1. Adult men and women aged ≥18 years 2. Currently using IC (via the urethra), performed by self or sole carer 3. Patients who have been IC users for at least 6 weeks 4. Patients where IC planned to continue for >12 months and 2 weeks 5. Able and willing to adhere to a 12‐month follow up period 6. Patient has provided written informed consent for participation in the trial prior to any trial specific procedures
Current exclusion criteria as of 22/07/2022: 1. Aged <18 years 2. Use of IC for self- dilatation of urethral stricture without bladder drainage 3. Non-urethral route for catheterisation e.g. Mitrofanoff 4. Use of less than one catheter per day or seven per week 5. External, non-sole carer required for IC (i.e. where sterile technique and catheter is required e.g. visiting community nurse performs IC) 6. Inability to give informed consent or have primary outcome information collected 7. Employee or relation of employee of a manufacturer or distributor of IC catheters 8. Women who report they are pregnant or who plan to become pregnant during the trial 9. Participation in another trial 10. Patients in the terminal stage of an illness _____ Previous exclusion criteria: 1. Age < 18 years 2. Use of IC for self- dilatation of urethral stricture without bladder drainage 3. Non-urethral route for catheterisation e.g. Mitrofanoff 4. External, non-sole carer required for IC (i.e. where sterile technique and catheter is required e.g. visiting community nurse performs IC) 5. Inability to give informed consent or have primary outcome information collected 6. Employee or relation of employee of a manufacturer or distributor of IC catheters 7. Women who report they are pregnant or who plan to become pregnant during the trial 8. Participation in another trial 9. Patients in the terminal stage of an illness