Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT04243902
Eligibility Criteria:
Inclusion Criteria:
* IDC-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine
* Independent with catheter care needs (e.g. bag emptying or valve opening)
* Able to transfer from bed to chair, stand and walk short distances unaided
* Able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter)
* Able to provide informed consent (self-report and research nurse assessment)
* Usual medical provider provides confirmation of suitability
Exclusion Criteria:
* End stages of a terminal illness
* Current treatment of urinary tract infection
* Has been advised by a urologist against using a valve on clinical grounds
* Lack of bladder sensation (e.g. unable to sense when bladder needs emptying)
* Previous bladder surgery that could affect the integrity of the bladder
* At known risk of autonomic dysreflexia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04243902
Study Brief:
Protocol Section:
NCT04243902