Automatic Catheter Valve Acceptability Evaluation
Research type
Research Study
Full title
Automatic Catheter Valve acceptability Evaluation
IRAS ID
286781
Contact name
Kelly Spencer
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS FT
ISRCTN Number
ISRCTN20193337
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
Considerable evidence exists to show the benefits of cycling the bladder, that is, allowing the bladder to fill and empty on a regular basis as opposed to the bladder remaining constantly empty, draining directly into a bag. Proven benefits include the maintenance of bladder capacity, reduced catheter blockages, earlier return of normal bladder function in patients presenting with urinary retention and development of fewer bladder stones. Patients with manual dexterity currently utilise a flip-flow valve to achieve this end. In essence, once the bladder feels full or after a set time period, they manually release the flip valve until the bladder is empty and then close the valve when finished. Patients who lack the ability to use a manual valve or who need constant supervision to release the valve need an alternative option.
This study is to evaluate the safety and usability of an, in-house fabricated, automatic catheter valve prototype for patients fitted with a Foley urinary catheter. The valve prototype will drain the users bladder every 2 hours via their catheter. The study will be carried out on 3 patients who are existing catheter users, one prototype valve each. The study will last for 6 hours while these patients will be continuously monitored and supported during this period. User feedback will be collected via a short questionnaire. The specific questions to address include safety, functionality, comfort and patient acceptability.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0245
Date of REC Opinion
5 Oct 2020
REC opinion
Further Information Favourable Opinion