RecruitingNot ApplicableNCT07019597

NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

Non-invasive NESA Neuromodulation Versus Transcutaneous Posterior Tibial Nerve Stimulation for the Treatment of Overactive Bladder


Sponsor

Daniel David Álamo Arce

Enrollment

25 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Non-invasive Neuromodulation Posterior Tibial (NTPG) and a medical device called Non-invasive neuromodulation NESA(NNG) for people with bladder dysfunction. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENon-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.

DEVICENon-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.


Locations(1)

University of Valencia

Valencia, Spain

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NCT07019597


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