Randomized controlled trial of intravesical electrical stimulation for underactive bladder

Limin Liao; Han Deng; Guoqing Chen; Hui Chen; Maping Huang; Keji Xie; Xinghua Wei; Zhihui Xu; Banggao Huang; Tie Chong; Qi Chen; He Xiao; Zhongming Huang; Haihong Jiang; Huafang Jing

doi:10.1111/bju.15885

Randomized controlled trial of intravesical electrical stimulation for underactive bladder

BJU Int. 2023 Mar;131(3):321-329. doi: 10.1111/bju.15885. Epub 2022 Oct 2.

Authors

Limin Liao^{1

2}, Han Deng^{1

2}, Guoqing Chen¹, Hui Chen³, Maping Huang³, Keji Xie⁴, Xinghua Wei⁴, Zhihui Xu⁵, Banggao Huang⁵, Tie Chong⁶, Qi Chen⁶, He Xiao⁷, Zhongming Huang⁷, Haihong Jiang⁸, Huafang Jing¹

Affiliations

¹ Department of Urology, China Rehabilitation Research Centre, Rehabilitation School of Capital Medical University, Beijing, China.
² University of Health and Rehabilitation Sciences, Qingdao, Shandong, China.
³ Guangdong Work Injury Rehabilitation Hospital, Guangzhou, Guangdong, China.
⁴ Guangzhou First People's Hospital, Guangzhou, Guangdong, China.
⁵ Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.
⁶ The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China.
⁷ Peking Union Medical College Hospital, Beijing, China.
⁸ The 1st Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.

PMID: 36084065
DOI: 10.1111/bju.15885

Abstract

Aim: To evaluate the efficacy and safety of intravesical electrical stimulation (IVES) performed with a novel device in patients with underactive bladder (UAB).

Patients and methods: This 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.

Results: In the full analysis set (FAS), the mean (sd) PVR changes in the trial and control groups at 4 weeks were -97.1 (107.5) mL and -10.5 (86.7) mL, respectively (P < 0.01). Similar results were obtained in the per-protocol set (PPS): -102.9 (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.

Conclusions: The 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.

Keywords: bladder voiding efficiency; clinical trial; intravesical electrical stimulation; post-void residual urine; underactive bladder.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Electric Stimulation
Humans
Prospective Studies
Quality of Life
Single-Blind Method
Treatment Outcome
Urinary Bladder Diseases*
Urinary Bladder, Underactive*

Abstract

Publication types

MeSH terms

Grants and funding