Intermittent Catheterization in Spinal Cord Injured Men

Coloplast

Status: Terminated

Conditions: Spinal Cord Injuries

Treatments: Device: SelfCath (comparator); Device: Product B SelfCath and urine bag, Conveen Contour; Device: Product A SelfCath and urine bag, Conveen Security+

Study type: Interventional

Funder types: Industry

Identifiers

NCT02230540

CP250

Details and patient eligibility

About

The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.

Enrollment: 8 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has given written informed consent
• Is at least 18 years of age and has full legal capacity
• Is a male
• Has an Spinal Cord Injury diagnosis

Exclusion criteria

• Participating in other interventional clinical investigations or have previously participated in this investigation
• Known hypersensitivity toward any of the test products
• Serious abdominal scars
• Symptoms of urinary tract infections

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Sequence A

Experimental group

Description:

Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions. Measurement of residual urine at different positions.

Treatment:

Device: SelfCath (comparator)

Device: Product A SelfCath and urine bag, Conveen Security+

Sequence B

Experimental group

Description:

Based on results from sequence A, sequence B may or may not be initiated. Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product B in different positions. Measurement of residual urine at different positions.

Treatment:

Device: SelfCath (comparator)

Device: Product B SelfCath and urine bag, Conveen Contour