Urinary tract infection Urological and Genital Diseases Urinary tract infection, site not specified
Conditions
Interventions
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 randomis
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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 _____ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/10/2024: The occurrence of at least one episode of Microbiologically Confirmed Symptomatic Urinary Tract Infection with Help-seeking/Self-help behaviour (MCS-UTI+HS) over the 12-month follow-up period, defined by the following criteria: 1. Presence of Symptoms: At least one new or worsening sign or symptom from the trial symptom set or other symptoms reported by the participant 2. Help-seeking/Self-help Behaviour: The participant seeks help and/or treatment from a GP, researcher, or other healthcare professional, or implements their self-help strategy (e.g., increasing fluid intake, self-administration of antibiotics) 3. Microbiological Confirmation: A single catheter urine specimen during a symptomatic episode shows ?103 colony-forming units (cfu)/mL of ?1 bacterial species, either before or after starting antibiotic treatment. _____ Previous primary outcome measure as of 22/07/2022 to 18/10/2024: 1. At least one episode over the 12-month follow-up period of Microbiologically Confirmed Symptomatic Urinary Tract Infection with Help-seeking behaviour (MC SH-UTI) defined as: 1.1. Presence of at least one sign or symptom (S; new or worsening; listed on the trial symptom set or other symptoms reported by the participant) AND 1.2. Help-seeking behaviour (i.e. participant seeks help and/or treatment from GP/researcher or other HCP or implements own self-help strategy e.g. increase fluid intake, self-administration of antibiotics) AND 1.3. 10(3) colony-forming units (cfu)/mL of =1 bacterial species in a single catheter urine specimen taken during a symptomatic episode before or after starting antibiotic treatment _____ Previous primary outcome measure: At least one episode over the 12 month follow-up period of Microbiologically Confirmed Symptomatic Urinary Tract Infection with Help-seeking behaviour (MC S UTI + H) defined as - Presence of at least one sign or symptom (S; new or worsening; listed on the trial symptom set or other | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/07/2022: 1. The number of MC SH-UTI over the 12-month follow-up measured as an incidence rate 2. At least one episode over the 6-month follow-up period of microbiologically confirmed symptomatic urinary tract infection with help-seeking behaviour (MC SH-UTI) as defined for the primary outcome 3. The number of MC SH-UTI over the first 6 months of follow-up measured as an incidence rate 4. Antibiotic use: Rate per month of prescription of antibiotics for presumed S-UTI (with or without meeting MC SH-UTI definition above) during the 12-month period as reported by the monthly questionnaire. This will also be examined over the first 6 months of follow-up. 5. Haematuria: Rate per month and proportion of 6-monthly urine samples meeting criteria of micro haematuria defined as >10/ml RBC as reported from routine urine sample during the 12-month follow-up. This will also be examined over the first 6 months of follow-up. 6. Urethral bleeding: Rate per month of visible urethral bleeding during 12-month follow-up period as reported via monthly questionnaire. This will also be examined over the first 6 months of follow-up. 7. User quality of life (QoL): QoL recorded by ISC-Q (Pinder tool) at 6 and 12 months. The Pinder tool reports on single-use catheter only. A modified version for reporting on multi-use catheters will be used for mixed-use strategy. A weighted average of the two score completions will be used for the intervention (mixed-use) group: the weights will reflect the proportion of time catheters were used as single and multi-use. 8. Health status recorded by the EQ-5D-5L questionnaire 9. Proportion of participants expressing preference for one or other catheter management strategy (mixed or single-use only) in the intervention arm at 6 and 12 months as measured by the 6-month and end-of-study (EoS) questionnaire 10. Costs of managing multi-use catheters versus single-use only. Measured by prescription of catheters, support | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed