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NCT Number: NCT07019597

NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

Location status: Recruiting

Location contact

Laura Fuentes-Aparicio, PhD. Physical Therapy

CONTACT

[email protected]

699682391 ext. 0034

Laura Fuentes-Aparicio, PhD. Physical Therapy

SUB_INVESTIGATOR

Paloma Blasco Sonora, Physical Therapy

CONTACT

656438815 ext. 0034

Paloma Blasco Sonora, Physical Therapy

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: NESA neuromodulation, NESA ultra low currents

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.

Other names: NEUROTRAC MYOPLUS PRO

Primary outcomes

  1. SF-36 questionnaire

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

    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.

Secondary outcomes

  1. Pittsburgh questionnaire

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

    Sleep quality using the Pittsburgh questionnaire, consisting of 19 items that analyse 7 different components of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction). Each item is scored from 0 to 3. The total score of the scale ranges from 0 to 21 points where the lower end represents good sleep quality, and the upper end represents poor sleep quality

  2. ICIQ-UI Short Form

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

    Perception of frequency, severity of urinary incontinence (UI) and patient quality of life were assessed using the International Consultation on Incontinence Questionnaire (ICIQ-SF) validated questionnaire, where the individual's daily experience of urination and incontinence is answered with three scored items and one unmarked self-diagnostic item.

  3. Bladder Control Self-Assessment Questionnaire (B-SAQ)

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

    Bladder symptoms and discomfort were assessed using the Bladder Control Self-Assessment Questionnaire (B-SAQ), a validated questionnaire consisting of 8 questions grouped into two scales, each with a scale of 0 to 3 points, giving a maximum score of 24 points (12 in each group).

  4. Personal satisfaction of patients

    Time frame: In the follow-up (two month later)

    After two months they were asked about their satisfaction with the treatment received (numerical scale from 0 not satisfied -10 very satisfied), whether they continued to do the exercises and whether they had any side effects after the treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura FUENTES-APARICIO, PhD. Physical Therapy

CONTACT

[email protected]

669682391 ext. 0034

Raquel I Medina-Ramírez, PhD. Physiotherapist

CONTACT

[email protected]

0034 665265685 ext. 0034

Sponsors and collaborators

Lead sponsor

Daniel David Álamo Arce

Other

Registry information

Official study title

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

Acronym: NesaTibial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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