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Breathing-controlled Electrical Stimulation BreEStim for Management of Neuropathic Pain and Spasticity

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Published on: January 10, 2013

Randomized controlled trial of intravesical electrical stimulation for underactive bladder.

Limin Liao^1,2, Han Deng^1,2, Guoqing Chen¹

¹Department of Urology, China Rehabilitation Research Centre, Rehabilitation School of Capital Medical University, Beijing, China.

BJU International

|September 9, 2022

Summary

This study shows a novel intravesical electrical stimulation (IVES) device significantly improved bladder function in underactive bladder (UAB) patients. The device demonstrated safety, with minimal adverse events, warranting further clinical utility research.

Keywords:

bladder voiding efficiency clinical trial intravesical electrical stimulation post-void residual urine underactive bladder

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Area of Science:

Urology
Medical Devices
Clinical Trials

Background:

Underactive bladder (UAB) poses a significant challenge in urological care.
Current treatment options for UAB have limitations, necessitating novel therapeutic approaches.

Purpose of the Study:

To assess the efficacy and safety of a new intravesical electrical stimulation (IVES) device for treating UAB.
To compare the novel IVES device against conventional IVES in a randomized controlled trial.

Main Methods:

A multicenter, prospective, single-blind, randomized controlled trial was conducted with 76 UAB patients in China.
Patients were randomized 1:1 to receive conventional IVES or IVES with an open circuit device for 4 weeks.
Primary endpoint: change in post-void residual urine volume (PVR); Secondary endpoints: maximum urinary flow rate (Qmax), bladder voiding efficiency (BVE), clean intermittent catheterization (CIC) frequency, and quality of life scores.

Main Results:

The novel IVES device group showed a statistically significant reduction in PVR compared to the control group (P < 0.01).
Significant improvements in Qmax (P=0.04) and BVE (P<0.01) were observed in the novel IVES group.
No significant differences were found in CIC frequency or quality of life scores between groups. Therapy-related adverse events were infrequent and mild, primarily urinary tract infections.

Conclusions:

The novel IVES device is effective and safe for improving bladder function in patients with UAB.
Further research is recommended to validate the clinical utility and long-term outcomes of this innovative device.