Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects
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.


Options:
A: Inclusion Criteria:

1. Subject is a male IC user able to self-catheterise
2. Subject has used hydrophilic-coated ICs for at least 1 month
3. Subject is at least 18 years old.
4. Subject has provided informed consent.

Exclusion Criteria:

1. 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).
2. Subject has known abnormalities in the lower urinary tract.
B: Inclusion Criteria:

* Is at least 18 years of age
* Has given written informed consent
* Has neurogenic bladder dysfunction
* Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
* Is able to self-catheterise
* Is able to use SpeediCath® compact catheters
* If spinal cord injury subject, injury must have occurred more than 12 months ago
* Covered by Social security system

Exclusion Criteria:

* Has used SpeediCath® compact catheters (not including screening for this investigation)
* Is admitted to rehabilitation centre
* Subjects using primarily catheter sets
* Is pregnant or breast-feeding
C: Inclusion Criteria:

* is male and at least 18 years of age
* is self-catheterizing at least 3 times a day
* has been performing catheterizations for at least 2 months
* wheelchair bound
* is able to use a size 12 or 14 French straight catheter
* is willing and able to follow the study protocol and Investigator's instructions
* is, in the opinion of the Investigator, qualified to participate

Exclusion Criteria:

* has cognitive impairments that preclude completion of study protocol
* cannot communicate as determined by the Investigator
* has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
* has a symptomatic urinary tract infection determined by interview
* has a retracted penis
* has participated in a study during the previous 30 days involving catheterization
* has been diagnosed with an enlarged prostate
* has urethral strictures, false passages, or urethral obstruction
D: Inclusion Criteria:

* age ≥ 2 years,
* diagnosis of spina bifida,
* had self-IC or performed by a trained person ≥ 3 months using reused PVC catheter (1 per week) with clean technique,
* able to read and understand informed consent

Exclusion Criteria:

* other causes of neurogenic bladder,
* symptomatic UTI at the time of initial evaluation,
* inconsistent IC,
* indwelling catheter,
* allergy to PVC,
* urethral pathology (ie stricture, false passage, hypospadias)
* rejection to participate in trial

Answer: A