A new bladder‐emptying method in females with neurogenic bladder: A randomized, phase II trial

Aim To evaluate the performance of the new device compared with clean intermittent catheterization (CIC). Methods From March 2015 to March 2018, patients who were admitted to the urologic outpatient clinic. A new intraurethral self‐retaining device (ISRD) was made of medical grade silicone and it wa...

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Bibliographic Details
Published in:Neurourology and urodynamics 2019-08, Vol.38 (6), p.1721-1727
Main Authors: Calisto, Fernanda C. F. S., Vilar, Fabio O., Lustosa, Eugênio S., Calisto, Sérgio L. S., Schots, Heron O., Lima, Salvador V. C.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Anti-Infective Agents, Local - therapeutic use
Bladder
Catheterization
Catheters
Child
clean intermittent catheterization
Equipment and Supplies
Female
Humans
Incontinence Pads - statistics & numerical data
Intermittent Urethral Catheterization
Middle Aged
neurogenic bladder
new device
Patient Compliance
Patients
Prospective Studies
Quality of Life
Side effects
Silicones
Treatment Outcome
Urinary Bladder, Neurogenic - complications
Urinary Bladder, Neurogenic - psychology
Urinary Bladder, Neurogenic - rehabilitation
Urinary Catheterization
Urinary tract
Urinary tract infections
Urinary Tract Infections - epidemiology
Urinary Tract Infections - etiology
Urination
Urodynamics
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Summary:Aim To evaluate the performance of the new device compared with clean intermittent catheterization (CIC). Methods From March 2015 to March 2018, patients who were admitted to the urologic outpatient clinic. A new intraurethral self‐retaining device (ISRD) was made of medical grade silicone and it was inspired by similar catheters that use sliding disks to adjust or fix tubes used to drain the bladder. Patients were randomized into two groups (experimental group [GI]‐ISRD vs control group [GII]‐CIC). The evaluation was performed at the time of enrollment and 6 months after treatment. Intervention was initiated from the antisepsis of the perineal region and subsequent introduction of the device through the external urethral meatus. The primary outcome was quality of life (QOL). Urinary tract infections (UTIs) episodes, data on urodynamic parameters, adverse effects and number of diapers per day. Results A total of 177 subjects were analyzed. We found a significant improvement on QOL analysis in the ISRD group (P 
ISSN:0733-2467
1520-6777
DOI:10.1002/nau.24048