Leakage performance of Hybrid incontinence product

• Research type

  Research Study

• Full title

  A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product

• IRAS ID

  327359

• Contact name

  Janice Wiseman

• Contact email

  janice.wiseman1@nhs.net

• Sponsor organisation

  Essity / BSN medical GmbH

• ISRCTN Number

  ISRCTN46745645

• Clinicaltrials.gov Identifier

  NCT00000000

• Clinicaltrials.gov Identifier

  000000000000000, 000000000000

• Duration of Study in the UK

  0 years, 5 months, 29 days

• Research summary

  This clinical investigation is designed to evaluate the clinical performance and safety of a new absorbing hygiene product medical device when used as intended in subjects affected with urinary/ faeces incontinence compared to a reference device representing standard of care in a care home setting. All residents will use their regular device for a 10-day baseline period followed by 13-15 days of investigational device use and the actual and perceived performance of the devices will be compared.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  23/SC/0284

• Date of REC Opinion

  31 Aug 2023

• REC opinion

  Further Information Favourable Opinion