To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be the improvement value of overactive bladder symptom score (OABSS) after 12-week treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
109
The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.
Beijing Hospital
Beijing, Beijing Municipality, China
West China Hospital
Chengdu, China
Nan Fang Hospital
Guangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The change of overactive bladder symptom score (OABSS) after 12-week treatment compared with baseline
OABSS is evaluated via 3-day voiding diary and urinary voiding events of the previous week at week 0, 4, 8 and 12 after treatment. Evaluate OABSS improvement from baseline after 12 weeks of treatment and compared between the Treatment and the Control groups
Time frame: 12 weeks
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Shanghai Fifth People's Hospital
Shanghai, China
Shanghai General Hospital
Shanghai, China
The First Affiliated Hospital of XI'AN JiaoTong University
Xi'an, China