Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-29

Study Completion Date

2018-11-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Intermittent Urethral Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Period One

LoFric, hydrophilic urinary catheter for single use. The study device is based on commercially available hydrophilic urinary catheters for intermittent catheterization, but with a different coating process than the comparator. Treatment Period One will last 1 week.

Group Type EXPERIMENTAL

Treatment Period One

Intervention Type DEVICE

LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

Treatment Period Two

CE-marked LoFric®, hydrophilic urinary catheter for single use. The comparator product is today commercially available and produced by WHC. Treatment Period Two will last 1 week.

Group Type ACTIVE_COMPARATOR

Treatment Period Two

Intervention Type DEVICE

CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

Interventions

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Treatment Period One

LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

Intervention Type DEVICE

Treatment Period Two

CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No