MultICath: A multicentre randomised controlled trial comparing mixed catheter management (combination of multi- and single-use) vs single-use catheter management by intermittent catheter users over 12 months

Not Applicable

• Conditions: rinary tract infection; Urological and Genital Diseases; Urinary tract infection, site not specified

• Registration Number: ISRCTN42028483
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-05
• Last Update Posted: 18 June 2024
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 578

Inclusion Criteria

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

Exclusion Criteria

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
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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

Study & Design

• Study Type: Interventional
• Study Design: Not specified