Bladder Scan of Residual Urine With New Catheter

Study Overview
=================
Brief Summary
-----------------
Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.

Detailed Description
-----------------
See brief summary

Official Title
-----------------
A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Test Catheter - SpeediCath Compact Male
* Device: SpeediCath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male IC user able to self-catheterise Subject has used hydrophilic-coated ICs for at least 1 month Subject is at least 18 years old. Subject has provided informed consent. Exclusion Criteria: Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease). Subject has known abnormalities in the lower urinary tract.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SpeediCath catheter<br>Standard treatment | Device: SpeediCath<br>* Catheter for intermittent catheterisation<br>* Other names: Test catheter;|
| Experimental: Test product<br> | Device: Test Catheter - SpeediCath Compact Male<br>* Compact catheter for intermittent catheterisation<br>* Other names: Test catheter;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Residual Urine Volume | Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation | 3 catheterisations on 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) |  | Study period | 
| Median Absolute RU Volume |  | 3 catheterisations on 1 day |