Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06484023

Acronym

TENVESI

Enrollment

Registered

2024-07-03

Start date

2024-03-29

Completion date

2024-06-17

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

neurostimulation

Brief summary

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.

Interventions

OTHERSurvey

quality of life questionnaire

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of quality of life in patients who received treatment correctly treatment with TENSI +	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026