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Randomized controlled trial of intravesical electrical stimulation for underactive bladder
Limin Liao1,2, Han Deng1,2, 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.
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.
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