Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder

Completed

• Conditions: Overactive Bladder
• Interventions: Other: Survey

• Registration Number: NCT06484023
• Lead Sponsor: Hopital Nord Franche-Comte

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-29
• Primary Completion: 2024-04-26
• Status Verified: 2024-06
• Study Completion: 2024-06-17
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overactive bladder TENSI+ patients	Survey	Patients monitored for overactive bladder and using the TENSI + device for at least 3 months

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Nord Franche-Comté; 🇫🇷 Trevenans, France