Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial.

This randomized clinical trial evaluates the success rate of neuro-adaptive therapy (NAT), applied with a specific neuro-adaptive regulator device, the Self-Controlled Electro Neuro-Adaptive Regulation (SCENAR), versus a sham for urge incontinence due to an overactive bladder (OAB). From February 2019 to May 2021, 66 patients were recruited. All subjects were randomized 1:1 at the first intervention visit to the NAT or sham procedure. Inclusion criteria were females between 18 and 80 years old with leakages due to an overactive bladder with unresponsiveness to medical therapy. Subjects were scheduled to receive up to eight weekly 20 min intervention sessions to obtain a complete (CR) or partial response (PR). Patients with no response after three sessions were considered as a failure. The primary end point of this trial was to assess the efficacy of NAT compared to an inactive sham intervention, evaluated 1 month after the last session. Analysis showed 23 (70%) patients responded (20 complete and 3 partial response) in the NAT group compared to 16 (48%) patients (all complete response) in the placebo arm (p = 0.014). Significant differences were maintained after the intervention, with persistent response at 3 months in 19 (58%) patients after active treatment and 14 (42%) after the placebo (p < 0.001), and at 6 months in 18 (55%) vs. 11 (33%) (p = 0.022), respectively. The number of sessions to achieve CR was similar in both arms, with 4.3 ± 1.9 in NAT and 3.9 ± 1.8 in the sham group (NS). Significant differences were observed between both groups for patients' satisfaction (p = 0.01). The binary model selected age as a predictor of response at the last follow-up. The odds ratio indicates that each year of increase in age, the probability of a positive response to treatment at 6 months decreases 0.95 (95% CI 0.9-0.99) times (p = 0.03). In conclusion, this pilot randomized trial gives evidence that neuro-adaptive electrostimulation is effective to treat refractory urge urinary incontinence due to OAB. The security and long-term efficacy of this treatment merits further evaluation. Moreover, its favorable profile and the economic advantages of the device make the evaluation of this promising technique mandatory in a primary therapeutic scenario.

Tratamiento del dolor pélvico crónico mediante terapia neuroadaptativa / Neuroadaptation therapy in chronic pelvic pain

Objetivo: Valorar el tratamiento de pacientes con dolor pélvico crónico mediante terapia neuroadaptativa. Material y métodos: Se presenta un estudio observacional, longitudinal y retrospectivo de 18 pacientes que presentaban dolor pélvico crónico refractario a tratamientos convencionales con analgesia y terapia física, y que fueron tratadas mediante terapia neuroadaptativa. Resultados: Se objetivaron antecedentes relacionables con el dolor en 15 casos: en siete (38,88%) pacientes, existió un parto reciente; en cinco (27,77%) pacientes, había una histerectomía reciente; en un (5,58%) caso, una fractura pélvica y en dos (11,16%) pacientes, protusiones discales. Se obtuvo una curación o respuesta completa en 15 (83,32%) pacientes, con una desaparición total de los síntomas tras tres (2-4) sesiones de tratamiento. En dos (11,16%) pacientes se obtuvo una respuesta parcial. La satisfacción obtenida en estos dos casos fue muy elevada, 10 (8-10), y la puntuación EVA bajó de 10 (9-10) a 3 (2-5), p < 0,01. Se consideró como fracaso un (5,58%) paciente, que no tuvo ninguna mejoría tras dos sesiones de tratamiento. Durante un seguimiento de 10 (6-13,50) meses, las dos pacientes con respuesta parcial mantuvieron su mejoría pero precisaron sesiones de recuerdo. De las 15 pacientes restantes, 12 (80%) pacientes permanecían sin dolor. Las tres pacientes restantes presentaron una recidiva parcial a los 13, 6 y 3 meses cada una. Se realizaron sesiones de rescate, obteniendo de nuevo una respuesta completa. No se objetivaron complicaciones. Conclusión: Con las limitaciones propias de unos resultados preliminares, la terapia neuroadaptativa parece ser un procedimiento eficaz para el tratamiento del dolor pélvico crónico de origen musculoesquelético.(AU)

Objetive: To evaluate a neuroadaptive therapy in patients with chronic pelvic pain. Material and methods: A retrospective observational study including 18 patients with chronic pelvic pain that were managed using neuroadaptive therapy after they had failed a conventional approach with physiotherapy and analgesia. Results: Data associated with previous chronic pelvic pain were seen in 15 patients. These included 7 (38.88%) cases of recent labour and 5 (27.77%) cases with a previous hysterectomy. There was also 1 (5.58%) cases with a pelvic fracture and disc herniations in 2 (11.16%) cases. Complete response was achieved in 15 (83.32%) patients after 3 (2-4) treatment sessions. A partial response was seen in 2 (11.16%) cases. In these 2 patients’ satisfaction with the procedure was high, 10 (8-10) and pain evaluation using a VAS lower, down from 10 (9-10) to 3 (2-5), p < 0.01. No response was achieved in 1 (5.58%) patient after 2 treatment sessions. In the mean 10-month (6-13.50) follow-up there was a continuing partial response in 2 patients after reinforced sessions, and complete response in 12 (80%) patients. Partial relapses, at 12. 6 and 3 months follow up, were seen in 3 patients with a complete response. These 3 patients were treated again with neuroadaptive therapeuty sessions, and a new complete response was achieved in all 3 cases. No complications were seen. Conclusion: Though there is limited experience, neuroadaptive therapy seems to be a feasible procedure to manage chronic pelvic pain.(AU)