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NCT Number: NCT03684941

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

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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Key information

Conditions

Intermittent Urethral Catheterization

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urologcentrum Borås, Borås, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment Period One

Device

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

Treatment Period Two

Device

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

Primary outcomes

  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

    Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two

    The primary objective of this study is to compare the subjects' tolerability of practising CIC by using two urinary catheters produced with different coating processes by means of subjective assessment scales.

Secondary outcomes

  1. Tolerability with regards to perceived pain, when using two different urinary catheters; test vs control catheter.

    Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period

    AE/SAE/ADE/SADE reporting/PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

  2. Tolerability with regards to presence of bleeding, when using two different urinary catheters; test vs control catheter

    Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period

    AE/SAE/ADE/SADE reporting /PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

  3. Tolerability with regards to perceived "other discomfort", when using two different urinary catheters; test vs. control catheter

    Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period

    PRO variables. Frequency of "other discomfort" (yes/ no) will be assessed in patient questionnaire. The frequency of "other discomfort" will be compared between the treatments. "Other discomfort" will be further specified using 5 graded scale (as for the other variables on the 5 graded scale the difference between the treatments will be calculated for each subject).

  4. Perception of the catheter's slipperiness, smoothness, flexibility, usability, and resistance, when practicing intermittent self-catheterization with urinary catheters; test vs. control catheter

    Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period

    PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

  5. To evaluate subject satisfaction with catheter; test vs. control catheter.

    Time frame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period

    PRO variables. Assessed in patient questionnaire for each subject. A 5 graded scale will be used to determine the satisfaction. The difference between the treatments will be calculated for each subject.

  6. Total number of DD/AE/SAE/ADE/SADE/ USADE.

    Time frame: 2 weeks in total.

    Total number of DD/AE/SAE/ADE/SADE/ USADE observed by the study personnel or spontaneously reported from subject will be calculated. The frequency of DD/AE/SAE/ADE/SADE/ USADE will be calculated for each treatment group.

Sponsors and collaborators

Lead sponsor

Dentsply International

Industry

Collaborators

  • Wellspect HealthCare

Registry information

Official study title

Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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