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

Abstract

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 < .01). ISRD group presented an important reduction (two episodes after ISRD use) on number of UTIs (P < .01) and diaper use, and significant improvement on bladder capacity (80 mL of the average improvement) (P < .01) and compliance (P = .01). Among all registered serious adverse effects, ISRD presented with lower proportion. Conclusions The new device has shown to be a safe and promising alternative for adequate emptying of the neurogenic bladder in female patients. Our study has a limitation that is related to a limited period of observation.