European Registry Study of Tensi Device for Managing Overactive Bladder Using Transcutaneous Posterior Tibial Nerve Stimulation

What this Trial Is About

Researchers are collecting data on Tensi, a newly released medical device that uses transcutaneous-posterior tibial nerve stimulation TC-pTNS to manage overactive bladder OAB. Preliminary studies have indicated that this device has a favorable safety and efficacy profile. This registry study aims to gather information on how well the device works, its safety, and factors that may predict success in everyday clinical use over one year. Participants will use the Tensi device in a real-world clinical setting. The study will observe patients over a total period of one year to monitor their responses to the device. There are no additional treatment groups or placebo controls as this is an observational study focused on the devices use in current practice. Participants will be assessed at the start, 3 months, and 12 months to measure subjective improvement and quality of life. Patient-reported outcome measures PROMs will be collected at these time points along with voiding diaries. The study will monitor safety and adherence through these assessments over the year-long participation.

Tensi+ European Registry