Clinical trial NCT03684941: Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.
Official title: Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization - A Prospective, Blinded, Randomized, Cross-over, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Urethral Catheterization
Lead sponsor: Dentsply Sirona Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wellspect HealthCare
First posted: 2018-09-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Tolerability of practicing CIC by using two urinary catheters produced with different coating processes measuring change over time by means of subjective assessment scales
timeFrame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two
Secondary outcomes:
measure: Tolerability with regards to perceived pain, when using two different urinary catheters; test vs control catheter.
timeFrame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
measure: Tolerability with regards to presence of bleeding, when using two different urinary catheters; test vs control catheter
timeFrame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
measure: Tolerability with regards to perceived "other discomfort", when using two different urinary catheters; test vs. control catheter
timeFrame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
measure: Perception of the catheter's slipperiness, smoothness, flexibility, usability, and resistance, when practicing intermittent self-catheterization with urinary catheters; test vs. control catheter
timeFrame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
measure: To evaluate subject satisfaction with catheter; test vs. control catheter.
timeFrame: 2 weeks in total. 1 week Treatment Period One/1 week Treatment Period Two. Safety variables spontaneously reported during whole study period
measure: Total number of DD/AE/SAE/ADE/SADE/ USADE.
timeFrame: 2 weeks in total.
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Urologcentrum Borås
city: Gothenburg
country: Sweden
facility: Urologkliniken vid Carlanderska AB
city: Halmstad
country: Sweden
facility: Specialistmottagningen i Urologi, Halmstad
city: Karlstad
country: Sweden
facility: Urologmottagningen, Centralsjukhuset Karlstad
city: Stockholm
country: Sweden
facility: GHP Urologcentrum Stockholm
city: Torsby
country: Sweden
facility: Uroterapimottagningen, Sjukhuset Torsby
city: Uppsala
country: Sweden
facility: Urologmottagningen, Akademiska sjukhuset
city: Örebro
country: Sweden
facility: Urologiska kliniken, Urologmottagningen Universitetssjukhuset Örebro
Study officials:
References: