Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheter… (NCT03684941) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.
Sweden60 participantsStarted 2018-08-29
Plain-language summary
This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Provision of informed consent.
* Males, aged 18 years and over.
* Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
* Practice CIC at least 2 times daily.
* Using catheters in the size CH 12 or CH 14, Nelaton tip, and able to use catheter length of 40 cm.
* Experienced users of CIC defined as a minimum of three months on therapy.
* Adults able to read, write and understand information given to them regarding the study.
Exclusion Criteria:
* Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥103 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
* Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
* Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
* Previous enrolment or randomisation of treatment in the present study.
* Simultaneous participation in another clinical study that may impact the primary endpoint.
* Severe non-compliance to protocol as judged by the investigator
What they're measuring
1
Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales
Timeframe: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two