NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-invasive neuromodulation NESA(NNG): NESA is a non-invasive monitoring device, which emits low frequency (1.3-14.28 Hz, depending on the programme), low intensity (0.1-0.9 mA), low voltage (±3 V) ultra low currents, and therefore imperceptible to the patient. It is based on neuromodulation of the autonomic nervous system.

Non-invasive Neuromodulation Posterior Tibial (NTPG): NTPG is an electrotherapy using a device called NEUROTRAC MYOPLUS PRO (brand name) to perform non-invasive TENS-type electrotherapy with biphasic currents.

Study summary

Introduction: Overactive bladder (OAB) is a common condition characterized by urinary urgency, frequency, and, in some cases, urge incontinence. Non-invasive neuromodulation has emerged as an effective therapeutic option by modulating the neural pathways involved in bladder control. This approach offers a promising alternative for patients who do not respond to conventional treatments.

Objectives: To evaluate the effect of non-invasive NESA neuromodulation compared to posterior tibial stimulation in patients with overactive bladder.

compared to posterior tibial stimulation, with same-day exercises and patient education on quality of life, symptoms, discomfort and sleep.

day of the session and patient education on quality of life, symptoms, discomfort and sleep.

Methods: Twenty-four patients (24 women), aged 38-85 years with overactive bladder will be included in this experimental clinical trial study. Each patient will attend ten sessions two days a week. Patient life quality will be measured using SF-36, sleep quality with the Pittsburgh questionnaire, perception of urinari incontinence (UI) symptoms and patient quality of life with the ICIQ-SF questionnaire. All these variables will be measured before, immediately after the ten sessions and at two months after the end of treatment.

Ethic: The study was approved by the ethics committee of the University of Valencia, and all participants will be given an informed consent form.

Eligibility

Primary outcome measure(s)

• SF-36 questionnaire — Before treatment, immediately after the treatment is finished and at two months later (follow-up)
  The SF-36 is a 36-question survey that assesses health-related quality of life, measuring eight key domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. It's a widely used tool in clinical practice and research for evaluating health status and assessing the impact of interventions.

Trial sites (1)