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

Dentsply International60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Intermittent Urethral Catheterization

Interventions

Treatment Period OneDEVICE

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

Treatment Period TwoDEVICE

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Urologcentrum Borås

Borås, Sweden

Urologkliniken vid Carlanderska AB

Gothenburg, Sweden

Specialistmottagningen i Urologi, Halmstad

Halmstad, Sweden

Urologmottagningen, Centralsjukhuset Karlstad

Karlstad, Sweden

Outcomes

Primary Outcomes

Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales

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.

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

Secondary Outcomes

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

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.

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

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

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.

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

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

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).

Data from ClinicalTrials.gov

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