NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
NCT07019597 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-06-13
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
- 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.
Sponsors & Collaborators
-
Daniel David Álamo Arce
lead OTHER
Principal Investigators
-
Paloma Blasco-Sonora, Physical Therapy · University of Valencia
-
Laura FUENTES-APARICIO, PhD. Physical Therapy · University of Valencia
-
Raquel Medina-Ramírez, PhD. Physical Therapy · University of Las Palmas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2025-08-01
- Completion
- 2025-09-01
Countries
- Spain
Study Locations
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