Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder

Rationale :

Overactive bladder (OAB) is a common condition that can have a major impact on quality of life. Transcutaneous peripheral electrical stimulation therapies are a recognized treatment option, but their mechanisms of action are still not fully understood.

Recent data suggest that their effectiveness may be related to changes in the autonomic nervous system. However, no study has yet evaluated this effect in patients with non-neurogenic overactive bladder. This study aims to better understand the physiological mechanisms involved, improve knowledge about these treatments, and contribute to their better use in clinical practice.

Objectives :

Primary objective:

The primary objective of this study is to evaluate the impact of transcutaneous electrical stimulation therapies on the overall balance of the autonomic nervous system in patients with overactive bladder.

Secondary objectives:

• To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
• To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
• To assess the clinical effectiveness of transcutaneous electrical stimulation on associated pelvic floor dysfunctions, including anal incontinence, constipation, and genitosexual disorders.
• To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.

Study design :

This is a prospective, single-center, observational study conducted in routine clinical practice. It will include female patients with overactive bladder who are receiving transcutaneous peripheral electrical stimulation as part of their usual care.

Study procedure :

After confirmation of the diagnosis of overactive bladder by a specialist physician, patients will be prescribed transcutaneous peripheral electrical stimulation, transcutaneous tibial nerve stimulation (TTNS) or interferential stimulation (IF). They will then be referred to the study investigator for an inclusion visit.

At the initial visit (Week 0), after checking the eligibility criteria and obtaining informed consent, participants will receive pelvic health education and their first electrical stimulation session. Heart rate variability will be recorded using an ECG Holter monitor. Clinical data and study questionnaires will also be collected.

Participants will receive two 72-hour bladder diaries. The first will be completed at the beginning of the study and the second before the final visit.

Treatment will continue for 12 weeks according to the prescribed method: TTNS will be performed at home, IF will be performed in a physiotherapy clinic. A follow-up telephone call will be made at 6 weeks (± 1 week) to assess treatment adherence.

At 12 weeks (± 1 week), participants will attend a final visit. This visit will include an electrical stimulation session with HRV measurement, completion of the follow-up questionnaires, and collection of the final bladder diary.

Data collected at baseline and at 12 weeks will be compared to assess the impact of electrical stimulation therapies on the autonomic nervous system and overactive bladder symptoms.

Inclusion criteria

• Female
• Adult patient aged 18 years or older
• Clinical diagnosis of overactive bladder made by a urologist or gynecologist with no identified cause
• Eligible for transcutaneous tibial nerve stimulation (TTNS) or interferential stimulation (IF) as part of the management of non-neurogenic overactive bladder
• Body mass index (BMI) ≤ 30 kg/m²
• Able to understand and complete the study questionnaires independently
• No objection to participating in the study.

Exclusion criteria

• Neurogenic overactive bladder.
• Local irritative factors, such as bladder stones, bladder tumors, or urinary tract infection.
• Previous treatment with transcutaneous tibial nerve stimulation (TTNS).
• Previous treatment with interferential stimulation (IF).
• Contraindications to electrical stimulation, including: cancer, Pacemaker, Pregnancy, Conductive prosthetic material in the area of stimulation, Heart disease, Epilepsy, Active phlebitis or thrombophlebitis, Skin lesions in the treatment area
• Use of anticholinergic medication during the previous three weeks
• Objection to participating in the study.