Evaluation of Residual Urine After Intermittent Catheterisation

Coloplast

Status: Completed

Conditions: Healthy

Treatments: Device: Intermittent catheter; Device: Compact intermittent catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00324233

DK052CC

Details and patient eligibility

About

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Enrollment: 36 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male
• 18 years and above
• A negative urine dip-stick
• Have signed informed written consent to participate

Exclusion criteria

• The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

SC

Active Comparator group

Description:

Speedicath (SC) catheter is a catheter for intermittent catherisation

Treatment:

Device: Intermittent catheter

SCCM

Experimental group

Description:

SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males

Treatment:

Device: Compact intermittent catheter