Randomized controlled trial of intravesical electrical stimulation for underactive bladder

Abstract

To evaluate the efficacy and safety of intravesical electrical stimulation (IVES) performed with a novel device in patients with underactive bladder (UAB). Patients and MethodsThis was a multicentre, prospective, single-blind, randomized controlled clinical trial of patients with UAB in China. Eligible patients were randomly assigned in a 1:1 ratio to receive conventional IVES (n = 38) or IVES with an open circuit (n = 38). The primary efficacy measure was change from baseline in post-void residual urine volume (PVR) after 4 weeks of treatment. Secondary efficacy measures included changes in maximum urinary flow rate (Q max ), bladder voiding efficiency (BVE), number of 24-h clean intermittent catheterization (CIC) procedures, and Patient Perception of Bladder Condition-Scale (PPBC-S) and American Urological Association Symptom Index Quality of Life (AUA-SI-QoL) scores from baseline after 4 weeks of treatment. Adverse events (AEs) were monitored throughout the trial. ResultsIn the full analysis set (FAS), the mean (SD) PVR changes in the trial and control groups at 4 weeks were À97.1 (107.5) mL and À10.5 (86.7) mL, respectively (P < 0.01). Similar results were obtained in the per-protocol set (PPS): À102.9 (100.0) mL vs 0.7 (82.5) mL (P < 0.01). In the FAS and PPS, Q max improved significantly at 4 weeks (P = 0.04 and P = 0.03). In the FAS and PPS, BVE was significantly improved at 4 weeks in the two groups (P < 0.01 and P < 0.01), whereas no significant differences in the number of 24-h CIC procedures, PPBC-S score or AUA-SI-QoL score were observed between the groups. Six possible therapy-related AEs occurred in six patients (four in the trial group and two in the control group; P = 0.67), all of which were urinary tract infections. No severe AEs were reported. ConclusionsThe results of this clinical study strongly demonstrate that UAB patients benefit from this novel IVES device. More research is needed to validate the clinical utility of this device.

Efficacy in Using Urodynamic Parameters of Intravesical Electrical Stimulation for Detrusor Underactivity

“…Compared to the findings of this study, which demonstrated no statistically significant changes in the ND group, previous studies conducted by Liao et al 10 and Deng et al 11 showed positive effects in patients who might have problems in impulse transmission that involve the micturition reflex pathway, such as those with spinal cord injury, spinal canal stenosis, and postoperative lumbar disc herniation.…”

“…Improvements in urinary flow, post-voiding residual, voiding efficiency, and first sensation volume during the bladder filling phase were observed in the evaluation of urodynamic parameters following the IVES procedure. 10 , 11 In this study, we evaluate the efficacy of IVES by comparing urodynamic parameters before and after the IVES procedure. In previous studies, efficacy assessment was done by observing clinical changes in clean intermittent catheterization (CIC) status and subjective assessments of quality of life.…”

Intravesical Electrical Stimulation Improves Abnormal Prefrontal Brain Activity in Patients With Underactive Bladder: A Possible Central Mechanism

“…Subsequently, patients with UAB received IVES treatments using an FES-D1 stimulator and a DJ-A01 stimulating electrode (General Stim, Inc., Hangzhou, Zhejiang, China) ( Fig. 1 ) [ 19 ]. For the IVES procedure, a sterile, disposable 12F transurethral catheter with a DJ-A01 stimulating electrode was inserted into the bladder, which was then filled with 150 mL of body-temperature (37°C) sterile saline.…”

Intravesikale Behandlungsoptionen in der Neuro-Urologie – eine Übersicht

“…Die IVES wird zumeist in Therapiezyklen von 5 aufeinanderfolgenden Tagen für 3-4 Wochen angewendet [47]. Die Therapiedauer einer einzelnen Anwendung dauert zumeist 90 Minuten [43], es werden aber auch kürzere Therapiesitzungen durchgeführt [47].…”