NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

NCT07019597 | Recruiting DMC

• 1 other identifier: NesaTibial
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

overactive bladder; Transcutaneous neuromodulation; Nesa Non-Invasive Neuromodulation; Posterior tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

• SF-36 questionnaire

  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.

  Before treatment, immediately after the treatment is finished and at two months later (follow-up)

Secondary Outcomes (4)

• Pittsburgh questionnaire

  Sleep quality was assessed before, immediately after and at two months

• ICIQ-UI Short Form

  ICIQ-SF was assessed before treatment, immediately after the treatment is finished and at two months later (follow-up)

• Bladder Control Self-Assessment Questionnaire (B-SAQ)

  Before treatment, immediately after the treatment is finished and at two months later (follow-up)

• Personal satisfaction of patients

  In the follow-up (two month later)

Study Arms (2)

Group1: Non-invasive neuromodulation NESA (NNG group)

EXPERIMENTAL

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.

Device: Non-invasive neuromodulation NESA(NNG)

Group 2: Non Invasive Posterior Tibial Neuromodulation (NTPG)

ACTIVE COMPARATOR

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.

Device: Non-invasive Neuromodulation Posterior Tibial (NTPG)

Interventions

Non-invasive neuromodulation NESA(NNG) DEVICE

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.

Also known as: NESA neuromodulation, NESA ultra low currents

Group1: Non-invasive neuromodulation NESA (NNG group)

Non-invasive Neuromodulation Posterior Tibial (NTPG) DEVICE

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

Also known as: NEUROTRAC MYOPLUS PRO

Group 2: Non Invasive Posterior Tibial Neuromodulation (NTPG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel David Álamo Arce: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

RECRUITING

Related Publications (4)

• Teruel-Hernandez E, Lopez-Pina JA, Souto-Camba S, Baez-Suarez A, Medina-Ramirez R, Gomez-Conesa A. Improving Sleep Quality, Daytime Sleepiness, and Cognitive Function in Patients with Dementia by Therapeutic Exercise and NESA Neuromodulation: A Multicenter Clinical Trial. Int J Environ Res Public Health. 2023 Nov 6;20(21):7027. doi: 10.3390/ijerph20217027.

  PMID: 37947583 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Lo CW, Wu MY, Yang SS, Jaw FS, Chang SJ. Comparing the Efficacy of OnabotulinumtoxinA, Sacral Neuromodulation, and Peripheral Tibial Nerve Stimulation as Third Line Treatment for the Management of Overactive Bladder Symptoms in Adults: Systematic Review and Network Meta-Analysis. Toxins (Basel). 2020 Feb 18;12(2):128. doi: 10.3390/toxins12020128.

  PMID: 32085542 BACKGROUND

• Przydacz M, Golabek T, Dudek P, Lipinski M, Chlosta P. Prevalence and bother of lower urinary tract symptoms and overactive bladder in Poland, an Eastern European Study. Sci Rep. 2020 Nov 13;10(1):19819. doi: 10.1038/s41598-020-76846-0.

  PMID: 33188254 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paloma Blasco-Sonora, Physical Therapy

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Laura FUENTES-APARICIO, PhD. Physical Therapy

  University of Valencia

  STUDY DIRECTOR

• Raquel Medina-Ramírez, PhD. Physical Therapy

  University of Las Palmas

  STUDY DIRECTOR

Central Study Contacts

Raquel I Medina-Ramírez, PhD. Physiotherapist

CONTACT

0034 665265685; raquel.medina@ulpgc.es

Laura FUENTES-APARICIO, PhD. Physical Therapy

CONTACT

669682391; Laura.Fuentes@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Proffesor

Model Details: A single-blind, randomised controlled trial was conducted.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 13, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)