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

niversity of Southampton0 个研究点目标入组 578 人开始时间: 2019年9月5日最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•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

发起方

niversity of Southampton