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

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Dentsply

Status

Completed

Conditions

Intermittent Urethral Catheterization

Treatments

Device: Treatment Period Two
Device: Treatment Period One

Study type

Interventional

Funder types

Industry

Identifiers

NCT03684941
LOF-0034

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Treatment Period One
Experimental group
Description:
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.
Treatment:
Device: Treatment Period One
Treatment Period Two
Active Comparator group
Description:
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.
Treatment:
Device: Treatment Period Two

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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