This original investigation has the aim to study the overactive bladder syndrome being treated by NESA non-invasive neuromodulation. This medical condition may impair and cause discomfort in the quality of life of affected patients. The pathophysiological mechanism of this condition is still under investigation, but it is believed to involve the autonomic nervous system. 
Neuromodulation is a frequently used treatment option used by urologists, urogynecologists, and physiotherapists to manage overactive bladder syndrome. In this case, NESA non-invasive neuromodulation is a microcurrent system that enhances the functionality of the autonomic nervous system. Although this device was initially used for rehabilitating elite athletes, it is currently being applied to various pathologies, including chronic pain, urogynaecological symptoms and insomnia (1, 2).
The device utilises a patented algorithm to administer microcurrents, targeting the anatomically recognised points of the superficial nervous system in the extremities that are connected to the central nervous system. The application involves placing 24 electrodes on the wrists and ankles, with a directional electrode serving as a guide to concentrate impulses on specific areas. The directional electrode is placed at various positions on the vertebral levels S1-S2, L3, and C7. Physically, the device emits currents ranging from 0.1 to 0.9 mA and frequencies ranging from 1.14 to 14Hz. The voltage or potential difference is between 3 and 6 volts. Therefore, the microcurrents are imperceptible to patients during application (3).
This study evaluates the potential uses of NESA microcurrents in treating overactive bladder syndrom. We aim to study the uses and benefits of this new technology in treating this condition and whether it benefits the quality of life of patients. Additionally, the study will assess other important aspects of patients' health, including efficacy, quality of sleep, and perception of quality of life.

All the elaboration of this clinical trial follows the instructions of the CONSORT guidelines. The sample is divided between two different health centres and included 62 women over 18 years of age with diagnostic criteria for overactive bladder syndrome who were not receiving any treatment. At the end of the enrollment, the sample had 57 subjects. It was estimated a total sample size of 56 patients (28 in each group) so we could observe a reduction of 25% of micturition in the intervention group during the treatment. 
This study has a triple-blind design and the patients were divided into two groups: an intervention group (N=30) and a placebo group (N=27). Both groups attended two one-hour treatment sessions per week, until they had completed 10 sessions. The placebo device did not emit any electrical signals, but its appearance when switched on was identical to the real device. At the end of the treatment, the number of patients in each group decreased, with 24 subjects in the intervention group and 19 in the placebo. 
Results were collected at three different points in time during the intervention; before the treatment, 5 sessions into the intervention and after all the sessions. The data was collected from the following instruments:
- Three-day bladder diary
- Bladder control self-assessment questionnaire (CACV)
- Urinary incontinence questionnaire (ICIQ-SF)
- Pittsburgh Sleep Quality Test
- Spanish validated Insomnia Severity Index (ISI)
This protocol was approved by the corresponding ethical committee and all participants provided permission and signed informed consents forms.

The collected diary revealed significant differences over time, as the intervention group subjects showed a reduction in the number of 24-hour micturitions (p=0.043). No differences were observed in the number of nocturnal micturitions.
When comparing the results of the patients in the CACV, significant differences were found in the intervention group for both the variables expressing symptoms (p=0.04) and the discomfort variables (p=0.0003). Similarly, the difference in ICIQ-SF scores before and after treatment were also significant in the NESA group (p=0.007).
Although differences were found within the intervention group, these were not statistically significant when compared to the control group. This limitation may have been due to the small sample size.
Regarding sleep, there was a substantial difference between the groups, with statistically significant differences found in both the Pittsburgh test and the ISI (p<0.05). No adverse effects were reported by any patients during the treatment.

Although there was no significant change in nighttime urination, meaning that they were waking up the same number of times in the nights, the treatment improved the quality of sleep of patients. 
An improvement in the reduction of micturitions and bladder control was observed, as reported by both the patients' diary and the objective instrument used. The participants experienced a decrease in symptoms and discomfort after only a few sessions, suggesting that further sessions with this microcurrent device may yield even better results. It is important to note that this device does not cause physical habituation, so we can expect even more improvement over time.

Non-invasive neuromodulation may be a new form of treatment for patients with overactive bladder. NESA microcurrents have proven to be effective in these cases, improving patients' quality of life, symptoms in overactive bladder and even sleep quality.
Despite the small sample size, the results of this pilot study are encouraging and suggest the need for larger multicentre studies.

García, F., Fernández, D., Vázquez-Guerrero, J., Font, R., Moreno-Planas, B., Álamo-Arce, D., Medina-Ramírez, R., & Mallol-Soler, M. (2022). Recovery of the physiological status in professional basketball players using NESA neuromodulation treatment during different types of microcycles in season: A preliminary randomized clinical trial. Frontiers in Physiology, 13(November), 1-10. https://doi.org/10.3389/fphys.2022.1032020
Teruel-Hernández, E., López-Pina, J. A., Souto-Camba, S., Báez-Suárez, A., Medina-Ramírez, R., & Gómez-Conesa, A. (2023). Improving Sleep Quality, Daytime Sleepiness, and Cognitive Function in Patients with Dementia by Therapeutic Exercise and NESA Neuromodulation: A Multicenter  Clinical Trial. International Journal of Environmental Research and Public Health, 20(21). https://doi.org/10.3390/ijerph20217027
Medina-Ramírez, R. I., Molina-Cedrés, F., Báez-Suárez, A., & Álamo-Arce, D. (2021). Nesa Non-Invasive Neuromodulation; A New Frontier of Treatment of the Autonomous Nervous System in Physiotherapy. CPQ Orthopaedics, 5(4), 01-04.

Continence 12S (2024) 101511
DOI: 10.1016/j.cont.2024.101511