Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder
Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder
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 randomized parallel 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) PVC intermittent catheterization. Evaluations were
 established at 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 sterile
 technique.
The investigators performed a randomized 2-arm trial at University Hospital "Dr. José
 Eleuterio González", a third level hospital in Monterrey, Mexico. The study population were
 patients with spina bifida treated in University Hospital. Participants and parents were
 offered optional entrance to the study.

 Sample size was calculated considering a total of 165 active patients with spina bifida
 treated in University Hospital, using a power of 80%, an expected difference of 50% between
 arms, and alpha level set at 0.05. The sample size calculated was 83 subjects, using methods
 for correlated binary data and repeated measures.

 Subjects were randomized into 2 groups: Group 1 was assigned to use a single-use PVC
 catheter. Group 2 was assigned to use the standard practice modality, a reused PVC catheter.
 Both groups were instructed to use sterile water-soluble lubricant in each catheterization.
 In the reused catheter group, after catheterization, PVC catheter was washed with water and
 soap, and stored in a container with 0.5% benzalkonium chloride. Each catheter was programmed
 to last a week. Patients and parents were instructed to use clean technique by hand washing
 with water and soup, and penis/vulva cleansing with antiseptic wipes. Researchers reinforced
 the intermittent bladder catheterization technique before the trial. All participants were
 provided with written informed consent.

 Both groups had a follow-up of 8 weeks. Urine cultures were programmed at days 0, 7, 14, 28,
 42 and 56. Researchers collected all urine samples from a fresh midstream catheter specimen
 using sterile technique. At each appointment urine culture results were evaluated, and if
 symptoms of UTI were present (temperature greater than 38.3 ° C, turbidity or odorous),
 antibiotic therapy according to antimicrobial susceptibility. Side effects related to bladder
 catheterization (hematuria, urethral stenosis, false way) were also evaluated. Patients with
 UTI were treated with antibiotics adjusted to the urine culture and were instructed to
 continue catheterization.

 A clinical record format was used in all programmed appointments recording urine culture
 results, demographics, pharmacologic therapy, urological comorbidities, and urodynamic
 characteristics. Personal information related to participants identity was not recorded.

 Subjects were randomized into block sizes of 6 using a computer generated list. Blinding
 process was impossible due to the nature of intervention therapy.
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