Hypothesis / aims of study
Idiopathic overactive bladder syndrome is a medical entity that causes deterioration in the quality of life of the affected individuals. Different theories have been postulated as a pathophysiological mechanism, one of which is the involvement of the autonomic nervous system. Urologists, urogynecologists and physiotherapists use neuromodulation on a regular basis within our therapeutic arsenal to treat overactive bladder syndrome.
NESA® non-invasive neuromodulation system is a microcurrent system that bases its therapeutic effect on improving the functioning of the autonomic nervous system. Initially used in recovery in elite athletes, the application of NESA® non-invasive neuromodulation is essential for post-training or post-competition, enhancing recovery from nervous system fatigue. Currently, it is being used to treat different pathologies such as chronic pain or insomnia.
The device implements a patented algorithm for the administration of microcurrents, acts on the points that are anatomically known as the passage points of the superficial nervous system of the extremities and is connected to the central nervous system. The application is carried out by means of 24 electrodes placed on the wrists and forefoot. In addition, a directional electrode acts as a grounding electrode, concentrating the impulses on specific areas. A guiding ground electrode is placed varying its position at vertebral levels S1-S2, L3 and C7.
Its physical characteristics, intensities are from 0.1 to 0.9 mA, as well as frequencies from 1.14 to 14Hz. The voltage or potential difference is set to 3 or 6 volts. Microcurrents are imperceptible to patients at the time of application.
We designed a pilot study to determine the possible usefulness of the NESA microcurrent system in the treatment of overactive bladder syndrome.
The aim was to evaluate the efficacy, sleep quality and quality of life of the application of non-invasive NESA neuromodulation in the treatment of patients with an overactive bladder syndrome.
Study design, materials and methods
A randomised, triple-blind clinical trial was developed where samples were taken from two different centres. We included women over 18 with criteria for overactive bladder who were not undergoing any treatment.
Patients (n=46) were divided into two groups, intervention (n=19) and placebo (n=24). Subjects had 10 treatment sessions (2/week) with a specific protocol during 60 min. The placebo device had the electrical emission switched off, but the ignition appearance is identical to the real one.
The 3-day bladder diary, Overactive Bladder Control Self-Assessment Questionnaire (B-SAQ), the international incontinence test (ICIQ_UI SF test) together with Quality of Life (ICIQ_UI SF test) and the sleep quality test (Pittsburgh test and Insomnia Severity Index)) were analysed. All participants provided informed consent.
In the voiding diary we found significant differences over the time in the reduction in the amount of micturition in 24 hours in the intervention group p=0.043. We found no differences in the reduction in the number of nocturnal urinations. Comparing the clinical outcomes of patients using the Spanish version of the Overactive Bladder Control Self-Assessment Questionnaire (B-SAQ), significant differences were obtained for the intervention group over time for B-SAQ symptoms (p-value=0.04) and B-SAQ discomfort (p-value=0.003). In addition, significant differences were found for the incontinence questionnaire (ICIQ_UI SF) over time, showing a rapid improvement in the NESA group (p-value=0.007) and for the ICIQ_UI life quality division. Although there is a significant reduction in the intervention group, we did not find significant differences between groups in the results reported by the patient reported outcome measures.
Regarding sleep, significant differences were found in the intervention group over time and between groups in the Pittsburgh test and Insomnia Severity Index (p value=0.001). No patient found adverse effects throughout the treatment.
Interpretation of results
This study documented a significant reduction in the OAB patient-reported outcomes in a cohort of female patients with OAB, treated with the NESA® non-invasive neuromodulation system. Although the number of voiding episodes in 24 hours was reduced, no reduction in nocturia was demonstrated. However, a significant improvement in the quality of sleep is appreciated. Although there is a significant reduction in the intervention group, we did not find significant differences between groups in the results by the patient reported outcome measures. We attribute this fact to the small number of patients in the groups.
Neuromodulation based on the improvement of the functioning of the autonomic nervous system can be a new way of treatment for patients affected by overactive bladder syndrome. NESA showed a favorable safety profile.
The results of this pilot study, with a small number of patients, encourage us to design a multicenter study with a larger sample of patients.