CP268PE
Research type
Research Study
Full title
Product evaluation of SpeediCath Flex’s ability to - and ease of - navigation in normal to difficult male urehtral anatomy.
IRAS ID
206990
Contact name
Adele Brodie
Contact email
Sponsor organisation
Coloplast A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 23 days
Research summary
The study is a product evaluation with a new CE-marked catheter, the aim is to achieve feedback in regards to handling and satisfaction on Speed-iCath® Flex catheter. Potential claims regarding insertion and ease of insertion will be examined.\nDesign of the Product Evaluation \nColoplast wishes to evaluate SpeediCath® Flex in two different populations – Tiemann users and Vapro us-ers. Therefore, the evaluation is divided into two parts, hereafter called product evaluation A and B. \nIn product evaluation A, 50 Vapro nelaton users (straight or pocket) will be included and in product evaluation B, 75 Tiemann/coudé users will be included.\nPopulation\nThe population consists of male IC users who comply with the following inclusion and do not comply with the exclusion criteria:\n1.\tMale ≥18 years\n2.\tHas used intermittent self-catheterisation for at least 3 months \n3.\tHas normal or slightly reduced hand mobility \n4.\tHas used Vapro Nelaton (A) or Tiemann (B) catheters for at least 10 days \n5.\tUse catheter size CH12 or CH14 (must use same size during product evaluation)\n\nExclusion criteria for both Product evaluation A and B:\n1.\tCurrently receiving treatment for a urinary tract infection \n2.\tCurrently receiving chemotherapy\n \nTest product\nSpeediCath® Flex (CE-marked) is a ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation. The device is for single use only. The catheter contains a flexible tip that facilitates passage through the sphincter in the urethra and the catheter is shielded by a sleeve, which serves as protection from the users hands during insertion.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0219
Date of REC Opinion
27 May 2016
REC opinion
Favourable Opinion