Place and Efficacy of Treatment With Posterior Tibial Transcutaneous Neurostimulation in Women With Idiopathic Overactive Bladder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Nord Franche-Comte
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Assessment of quality of life in patients who received treatment correctly treatment with TENSI +
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported