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

NCT03684941 | Completed

• 1 other identifier: LOF-0034
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

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.

Conditions

Intermittent Urethral Catheterization

Outcome Measures

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

  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 Outcomes (6)

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

  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

  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

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

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

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

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

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

Study Arms (2)

Treatment Period One

EXPERIMENTAL

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.

Device: Treatment Period One

Treatment Period Two

ACTIVE COMPARATOR

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.

Device: Treatment Period Two

Interventions

Treatment Period One DEVICE

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

Treatment Period One

Treatment Period Two DEVICE

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

Treatment Period Two

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dentsply International: lead
• Wellspect HealthCare: collaborator

Study Sites (8)

Urologcentrum Borås

Borås, 503 32, Sweden

Location

Urologkliniken vid Carlanderska AB

Gothenburg, 405 45, Sweden

Location

Specialistmottagningen i Urologi, Halmstad

Halmstad, 302 46, Sweden

Location

Urologmottagningen, Centralsjukhuset Karlstad

Karlstad, 651 85, Sweden

Location

Urologiska kliniken, Urologmottagningen Universitetssjukhuset Örebro

Örebro, 701 85, Sweden

Location

GHP Urologcentrum Stockholm

Stockholm, 117 94, Sweden

Location

Uroterapimottagningen, Sjukhuset Torsby

Torsby, 685 34, Sweden

Location

Urologmottagningen, Akademiska sjukhuset

Uppsala, 751 85, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 26, 2018
• Study Start: August 29, 2018
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

SE (8)