Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder (TENVESI)

Hopital Nord Franche-Comte

Status: Completed

Conditions: Overactive Bladder

Treatments: Other: Survey

Study type: Observational

Funder types: Other

Identifiers

NCT06484023

2024-01

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

45 participants in 1 patient group

Overactive bladder TENSI+ patients

Description:

Patients monitored for overactive bladder and using the TENSI + device for at least 3 months

Treatment:

Other: Survey