NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

NCT ID: NCT07019597

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group1: Non-invasive neuromodulation NESA (NNG group)

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.

Group Type: EXPERIMENTAL

Non-invasive neuromodulation NESA(NNG)

Intervention Type: 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.

Group 2: Non Invasive Posterior Tibial Neuromodulation (NTPG)

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.

Group Type: ACTIVE_COMPARATOR

Non-invasive Neuromodulation Posterior Tibial (NTPG)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

NESA neuromodulation; NESA ultra low currents; NEUROTRAC MYOPLUS PRO

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daniel David Álamo Arce

OTHER

Sponsor Role: lead

Responsible Party

Daniel David Álamo Arce

Proffesor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paloma Blasco-Sonora, Physical Therapy

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Laura FUENTES-APARICIO, PhD. Physical Therapy

Role: STUDY_DIRECTOR

University of Valencia

Raquel Medina-Ramírez, PhD. Physical Therapy

Role: STUDY_DIRECTOR

University of Las Palmas

Locations

University of Valencia

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Raquel I Medina-Ramírez, PhD. Physiotherapist

Role: CONTACT

raquel.medina@ulpgc.es

0034 665265685 ext. 0034

Laura FUENTES-APARICIO, PhD. Physical Therapy

Role: CONTACT

Laura.Fuentes@uv.es

669682391 ext. 0034

Facility Contacts

Laura Fuentes-Aparicio, PhD. Physical Therapy

Role: primary

Laura.Fuentes@uv.es

699682391 ext. 0034

Paloma Blasco Sonora, Physical Therapy

Role: backup

656438815 ext. 0034

References

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.

Reference Type: BACKGROUND

PMID: 37947583 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2748771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32085542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33188254 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NesaTibial

Identifier Type: -

Identifier Source: org_study_id