Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-29

Study Completion Date

2024-06-17

Brief Summary

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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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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Overactive bladder TENSI+ patients

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

Survey

Intervention Type OTHER

quality of life questionnaire

Interventions

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Survey

quality of life questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No