NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation (NesaTibial)

Daniel David Álamo Arce

Status: Enrolling

Conditions: Bladder Dysfunction

Treatments: Device: Non-invasive neuromodulation NESA(NNG); Device: Non-invasive Neuromodulation Posterior Tibial (NTPG)

Study type: Interventional

Funder types: Other

Identifiers

NCT07019597

NesaTibial

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum criteria for a primary diagnosis of overactive bladder who have or have not received active/alternative treatments for this pathology.
• Patients with previous pharmacological treatments that have not obtained an adequate clinical response.
• Patients whose cognitive abilities are competent to participate in the study and are able to complete the study questionnaires and have given written consent to participate in the study.
• Without further contraindications for electrotherapy treatment such as serious use of pacemakers, pregnancy, internal bleeding, poor skin condition (ulcerations, wounds...) and/or phobia of electricity.

Exclusion criteria

• Presence of urinary fistula.
• Infections in the last 12 months.
• Haematuria during the trial period.
• Pregnancy or plans to become pregnant during the study.
• Pathology of the central or peripheral nervous system (multiple sclerosis, Parkinson's disease, etc.).
• Uncontrolled diabetes.
• Currently treated with Botox injections for the bladder or within the last year.
• Current treatment with interstim or currently implanted interstim device.
• Bladder outlet obstruction.
• Urinary retention.
• Treatment with more than two antidepressants and/or multiple benzodiazepines, as well as antiepileptics.
• Contraindications for electrotherapy treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Group1: Non-invasive neuromodulation NESA (NNG group)

Experimental group

Description:

Group 1: Non-invasive NESA® Neuromodulation (NNG) using NESA (Applied superficial stimulation, acronym in spanish) device with same-day exercise and education by providing common, non-individualised written instructions, such as dietary and social advice. NNG was performed with the patient supine, using NESA technology with gloves and anklets, with a total of 24 electrodes plus a directional electrode for global neuromodulation; NESA is a non-invasive monitoring device which emits ultra low frequency currents (1.3-14.28 Hz, depending on the programme), low intensity (0.1-0.9 mA), and low voltage (±3 V) and therefore imperceptible to the patient. Each day a different programme was applied. On the first three days, programme 1 (P1) 15 min, programme 2 (P2) 15 min and programme 7 (P7) 30 min were applied. From the fourth to the sixth day, P2 30 min and P7 30 min were applied, finishing the rest of the days with P3 30 min and P7 30 min. At the same time pelvic exercises were performed.

Treatment:

Device: Non-invasive neuromodulation NESA(NNG)

Group 2: Non Invasive Posterior Tibial Neuromodulation (NTPG)

Active Comparator group

Description:

Group 2: Non-invasive posterior tibial neuromodulation (NTPG) with same-day exercises and education through common, non-individualised written instructions. NTPG was performed by posterior tibial application plus pelvic exercises (same day of treatment) and advice, with the patient supine, using NEUROTRAC MYOPLUS PRO (brand name of the tibial stimulation device) to perform TENS (transcutaneous electric nerve stimulation) for 30 minutes. An electric current with a frequency of 10 Hz and pulse duration of 200μs was applied. The intensity was adjusted according to the patient's tolerance, with thumb flexion perceptible to visual inspection by the therapist. Two 50 x 50 millimeters electrodes were placed along the posterior tibial nerve pathway, one on the sole of the foot and the other near the medial malleolus on one leg.

Treatment:

Device: Non-invasive Neuromodulation Posterior Tibial (NTPG)