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Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

2014-08-27 03:13:01 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.

Description

Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.

Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.

40 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Spinal Cord Injury

Intervention

Intermittent catheter CP063CC, SpeediCath

Location

Rigshospitalet, dep. 2112
Copenhagen
Denmark
2100

Status

Completed

Source

Coloplast A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:01-0400

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Medical and Biotech [MESH] Definitions

Repair of the damaged neuron function after SPINAL CORD INJURY or SPINAL CORD DISEASES.

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Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.

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