NCT07019597

NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Daniel David Álamo Arce · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Dysfunction

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: Spain