Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT04243902
Brief Summary:
The fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.
Detailed Description:
The objective of this study is to assess preliminary safety, effectiveness, reliability, comfort and user acceptability of the valve with adults who have a long-term IDC and the feasibility of undertaking future community-based evaluation.
To do this the investigators will
* determine if the valve functions reliably i.e. automatically opens to drain urine within acceptable individual bladder volumes with a range of patients;
* determine if the valve functions effectively i.e. allows for the complete bladder emptying (\< 100ml post void residual) during rest and daily activities;
* determine if the process of filling and automatic draining is comfortable and acceptable for participants;
* collect preliminary data on the potential for bioburden/biofilm following in human use of the valve;
* assess the feasibility of undertaking a future randomised control trial of the valve.
Group 1 - The investigators will test the valve with participants (n=8) who currently use a standard manual valve (without leg-bag).This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation.
Group 2- The Investigators will test the valve with participants (n=8) who currently use a drainage bag with free drainage.
The data collection process and study procedures will be identical for both groups.
After use(in both groups), the valves will be examined microbiologically in the University of Southampton laboratory to detect bioburden and/or biofilm to ascertain a baseline for future studies.
Study:
NCT04243902
Study Brief:
Protocol Section:
NCT04243902