Evaluation of a New Catheter Material for Intermittent Catheterization

Wellspect HealthCare

Status: Completed

Conditions: Catheterization (Clean, Intermittent Urinary Catheterization)

Treatments: Device: LoFric PVC; Device: LoFric POBE 2.0

Study type: Interventional

Funder types: Industry

Identifiers

NCT01295281

LOF-0018

Details and patient eligibility

About

The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.

Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.

Enrollment: 107 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Males, aged 18 years and over
• Maintained urethra sensibility
• Practice intermittent self-catheterization at least 2 times daily
• Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
• Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
• Experience of using LoFric catheter within the last 12 months prior to study entry
• Adults able to read, write and understand information given to them regarding the study

Exclusion criteria

• Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
• Known urethral stricture at enrolment as judged by investigator
• Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
• Previous enrolment or randomisation of treatment in the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

107 participants in 2 patient groups

LoFric POBE 2.0 - PVC

Experimental group

Description:

First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC

Treatment:

Device: LoFric POBE 2.0

Device: LoFric PVC

LoFric PVC - POBE 2.0

Experimental group

Description:

First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.

Treatment:

Device: LoFric POBE 2.0

Device: LoFric PVC