CClinicalTrials.gg
CompletedNCT06484023TENVESIUpdated Jul 3, 2024

Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder

An observational study in Overactive Bladder, sponsored by Hopital Nord Franche-Comte. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Hopital Nord Franche-Comte · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Overactive Bladder

Keywords

  • neurostimulation
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 45 is below the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Hopital Nord Franche-Comte is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • Overactive bladder TENSI+ patients

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

    Other: Survey

Interventions

  • OtherSurvey

    quality of life questionnaire

06

What researchers measure

Primary outcomes

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

    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

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

07

Study locations

1 site
  • Hôpital Nord Franche-Comté
    Trevenans, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06484023
Lead sponsor
Hopital Nord Franche-Comte
Responsible party
Sponsor
First posted
Jul 3, 2024
Start date
Mar 29, 2024
Primary completion
Apr 26, 2024
Completion
Jun 17, 2024
Last update
Jul 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion