Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Clinical Trial Using Sterile Single-use and Reused Polyvinylchloride Catheter For Intermittent Catheterization With Clean Technique In Neurogenic Bladder Due to Spina Bifida
Brief Summary: The objective of the study is to determine whether single-use polyvinylchloride (PVC) catheters reduce urinary tract infections (UTI) compared to reused PVC catheters for patients with neurogenic bladder due to spina bifida that require intermittent catheterization for bladder emptying. The investigators conducted a clinical trial with an 8-week follow-up comparing single-use and reused (washed with soap and water, and stored in a container with benzalkonium chloride or washed with soap and water alone) PVC intermittent catheterization. Evaluations were established on days 0, 7, 14, 28, 42, and 56. Participants reported symptoms and urine culture results, collecting urine samples from a fresh midstream catheter specimen using a sterile technique.


Options:
A: 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
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:

* At least 18 years of age
* Has normal/impaired sensation in the urethra
* Self-catheterises at least 4 times per day
* Has used clean self-intermittent catheterisation for at least 14 days
* Is able to open and prepare the catheters for catheterisation
* Has signed the informed consent before any study related-activities.

Exclusion Criteria:

* Has a symptomatic urinary tract infection as assessed by the investigator
* Is mentally unstable as assessed by the investigator
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: D