NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

Official title

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

Overview

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.

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.

Primary outcome measures

• SF-36 questionnaire [Time frame: Before treatment, immediately after the treatment is finished and at two months later (follow-up)]

Secondary outcome measures (4)

• Pittsburgh questionnaire [Time frame: Sleep quality was assessed before, immediately after and at two months]
• 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)]
• Bladder Control Self-Assessment Questionnaire (B-SAQ) [Time frame: Before treatment, immediately after the treatment is finished and at two months later (follow-up)]
• Personal satisfaction of patients [Time frame: In the follow-up (two month later)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• University of Valencia — Valencia

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07019597 · NesaTibial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗