Test of new single-use intermittent micro-hole zone catheter in males
Research type
Research Study
Full title
CP334 A confirmatory, multi-centre, randomised, open label, controlled study confirming performance of a single-use intermittent micro-hole zone catheter in a population of adult male intermittent catheter users.
IRAS ID
312954
Contact name
Nikesh Thiruchelvam
Contact email
Sponsor organisation
Coloplast A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 12 days
Research summary
Coloplast is in the process of developing a new intermittent micro-hole zone catheter for males, to ensure thorough bladder emptying without the need for repositioning and with minimal urethral and bladder trauma
The aim of this investigation is to assess performance of this new micro-hole zone catheter.
The investigation will be conducted from March 2022 to August 2022, enrolling 72 subjects with equal split in DK, UK, DE and FR. In UK we expect up to 4 sites in total. Once enrolled the subjects will be in the study approximately 9 weeks.
During the investigation the subjects will be asked to come for up to 4 visits in the clinic where they will undergo several assessments (emptying of bladder, ultrasound measure of residual urine, stix) and answer a number of questionnaires. Between the visits they will have two periods of 4 weeks each, where the subject will use their own catheter for 4 weeks and the test catheter for 4 weeks in random order. After ended study procedures at visit 4, the subject will be completed.
The home setting group will only have remote visits, hence, they stay in their home. They will have up to 4 visits and undergo a limited number of assessments (hematuria, questionnaires). At visit 4 they will be completed in the study.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0097
Date of REC Opinion
4 Jul 2022
REC opinion
Further Information Favourable Opinion