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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier de Roubaix

About this trial

The goal of this observational study is to evaluate the impact of Transcutaneous Electrical Nerve Stimulation on the autonomic nervous system in adults women with overactive bladder.

The main question it aims to answer is :

Does Transcutaneous Electrical Nerve Stimulation to treat overactive bladder have an impact on the autonomic nervous system ?

To answer this question, the primary outcome measure will be heart rate variability (HRV) during transcutaneous electrical nerve stimulation therapy

Participants will:

* Receive their first and last sessions of transcutaneous electrical nerve stimulation in the hospital. * Complete questionnaires during their first and last transcutaneous electrical nerve stimulation sessions. * Have their heart rate variability measured during their first and last transcutaneous electrical nerve stimulation sessions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • heart rate variability assement

    Other intervention

    Participants will: * Receive their first and last sessions of transcutaneous electrical nerve stimulation in the hospital. * Complete questionnaires during their first and last transcutaneous electrical nerve stimulation sessions. * Have their heart rate variability measured during their first and last transcutaneous electrical nerve stimulation sessions. These interventions are performed specifically as part of the study and are not part of routine care.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Women with overactive bladder who have been prescribed transcutaneous electrical stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Heart rate variability

The primary outcome measure is the change in SDNN (Standard Deviation of Normal-to-Normal intervals, expressed in ms), a time marker of heart rate variability , between the initial measurement session (Week 0) and the final measurement session (Week 12)

Time frame
Baseline and Week 12

Secondary outcomes

1

To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

Change in the low-frequency power (LF, 0.04-0.15 Hz) of heart rate variability between Week 0 and Week 12, assessed for each of the three evaluation phases: * 1 resting phase * 2 active stimulation * 3 post-stimulation resting phase

Time frame
Baseline and Week 12
2

To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

Change in the High-frequency power (HF, 0.15-0.40 Hz) of heart rate variability between Week 0 and Week 12, assessed for each of the three evaluation phases: * 1 resting phase * 2 active stimulation * 3 post-stimulation resting phase

Time frame
Baseline and Week 12
3

To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

Low Frequency /High Frequency ratio : is calculated by dividing the low-frequency power by the high-frequency power.

Time frame
Baseline and Week 12
4

To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

Root Mean Square of Successive Difference (RMSSD) : it is calculated as the average of the time intervals between successive heartbeats. It is expressed in milliseconds (ms).

Time frame
Baseline and Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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