Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04243902
Status:
WITHDRAWN
Last Update Posted:
2023-10-06
First Post:
2019-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial
Sponsor:
University of Southampton
Organization:
Study Overview
Official Title:
Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants met all the inclusion criteria required within the recruitment time period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 245818 | OTHER | IRAS | View |