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

Intermittent Urethral Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684941
• Other study ID #: LOF-0034
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: November 19, 2018

Study information

• Verified date: December 2018
• Source: Dentsply International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Urethral Catheterization

Intervention

Device:
• Treatment Period One
LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip
• Treatment Period Two
CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip

Locations

Country	Name	City	State
Sweden	Urologcentrum Borås	Borås
Sweden	Urologkliniken vid Carlanderska AB	Gothenburg
Sweden	Specialistmottagningen i Urologi, Halmstad	Halmstad
Sweden	Urologmottagningen, Centralsjukhuset Karlstad	Karlstad
Sweden	Urologiska kliniken, Urologmottagningen Universitetssjukhuset Örebro	Örebro
Sweden	GHP Urologcentrum Stockholm	Stockholm
Sweden	Uroterapimottagningen, Sjukhuset Torsby	Torsby
Sweden	Urologmottagningen, Akademiska sjukhuset	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Dentsply International	Wellspect HealthCare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two
Secondary	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.	2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Secondary	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.	2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Secondary	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).	2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Secondary	Perception of the catheter's slipperiness, smoothness, flexibility, usability, and resistance, when practicing intermittent self-catheterization with urinary catheters; test vs. control catheter	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 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Secondary	To evaluate subject satisfaction with catheter; test vs. control catheter.	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.	2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
Secondary	Total number of DD/AE/SAE/ADE/SADE/ USADE.	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.	2 weeks in total.