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OpenTrials
Completed

NCT Number: NCT06484023

Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder

Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice. TENSI+ medical device is a treatment for overactive bladder. It is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. Discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. The aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients treated for overactive bladder
  • Patients using the TENSI+ for at least 3 months

Exclusion criteria

  • Neurological disease that may explain overactive bladder
  • Patient having received anticholinergic drug treatment during neurostimulation.
  • Have one or more contraindications to wearing the device: pacemaker, defibrillator, wearing a mechanical implant near the electrode placement area, ankle joint problems, damaged skin, cognitive impairment.

Treatment and study plan

Survey

Other

quality of life questionnaire

Primary outcomes

  1. Assessment of quality of life in patients who received treatment correctly treatment with TENSI +

    Time frame: Comparison before/after 3 month at least of TENS use

    Comparison of patients' quality of life with the OAB-q questionnaire after the installation of this therapy with patients' quality of life before the introduction of this therapy

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

Place and Efficacy of Treatment With Posterior Tibial Transcutaneous Neurostimulation in Women With Idiopathic Overactive Bladder

Acronym: TENVESI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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