RESUMEN
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.
RESUMEN
OBJECTIVES: This project aimed to improve care in managing urinary incontinence in older patients admitted to a medium-to-long-stay hospital by developing and implementing strategies to improve the compliance with best practice in managing urinary incontinence and decrease its prevalence. INTRODUCTION: Urinary incontinence (UI) is a major problem in hospitalized older people and is of great significance to public health. The application of evidence-based recommendations for this problem could be expected to improve the quality of care. METHODS: The project used the Joanna Briggs Institute's Practical Application of Clinical Evidence System and Getting Research into Practice audit tools for promoting change in healthcare practice. Participants were evaluated at baseline and at two follow-ups at three and six months after key strategies had been implemented. The location of this implementation project was the functional rehabilitation ward of a medium-to-long-stay Spanish hospital. RESULTS: In baseline audit there were four process criteria with a high level of compliance: two criteria with 35% and 44% respectively and one criterion without compliance. Action was taken to address the four barriers identified, leading to an increase in all cases except one, which was related to the characteristics of the patient. Prevalence of urinary incontinence decreased at follow-up. CONCLUSIONS: The development and implementation of strategies improved quality of care. This project obtained positive results in patient health, and the implementation of the strategies used decreased the prevalence of urinary incontinence in patients.