Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder.

ABSTRACT:

Objectives

To evaluate the efficacy and safety of a non-invasive low-frequency tibial nerve stimulator (TNS-01) vs sham control in relieving the symptoms of overactive bladder (OAB) patients.

Patients

Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly.

Methods

The subjects were 1:1randomized (block randomization with a block size of 4) to either active treatment (TNS-01 group) or sham treatment (sham group). Based on the randomization, the subject will be given either an active or sham device system (systems will only differ in the Instructions for Use and electrode size/shape). During the 12-week study period, all participants underwent three 30-min intervention

SUBMITTER: Zhang Z 

PROVIDER: S-EPMC11748249 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature