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 20...
| Authors: | ; ; ; ; ; ; |
|---|---|
| Format: | Article |
| Publication date: | 2023 |
| Country: | España |
| Institution: | Universidad Europea (UEM) |
| Repository: | ABACUS. Repositorio de Producción Científica |
| Language: | English |
| OAI Identifier: | oai:abacus.universidadeuropea.com:11268/12451 |
| Online Access: | http://hdl.handle.net/11268/12451 |
| Access Level: | Open access |
| Keyword: | Incontinencia urinaria Estimulación eléctrica transcutánea del nervio Neurología Tecnología médica Sistema endocrino |
| _version_ | 1878733807924805632 |
|---|---|
| author | Zapico, Álvaro |
| author2 | Ercilla, Julia Angulo Cuesta, Javier Saz Pérez, José Vicente Cuenca Zaldívar, Juan Nicolás Barreira Hernández, Diana Udina Cortés, Carlos |
| author2_role | author author author author author author |
| author_browse | Angulo Cuesta, Javier Barreira Hernández, Diana Cuenca Zaldívar, Juan Nicolás Ercilla, Julia Saz Pérez, José Vicente Udina Cortés, Carlos Zapico, Álvaro |
| author_facet | Zapico, Álvaro Ercilla, Julia Angulo Cuesta, Javier Saz Pérez, José Vicente Cuenca Zaldívar, Juan Nicolás Barreira Hernández, Diana Udina Cortés, Carlos |
| author_role | author |
| collection | ABACUS. Repositorio de Producción Científica |
| description | 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_5d615e051a7d50d376bdec571e68b310 |
| institution | Universidad Europea (UEM) |
| instname_str | Universidad Europea (UEM) |
| language | eng |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:abacus.universidadeuropea.com:11268/12451 |
| publishDate | 2023 |
| publishDateSort | 2023 |
| reponame_str | ABACUS. Repositorio de Producción Científica |
| spelling | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial Zapico, Álvaro Ercilla, Julia Angulo Cuesta, Javier Saz Pérez, José Vicente Cuenca Zaldívar, Juan Nicolás Barreira Hernández, Diana Udina Cortés, Carlos Incontinencia urinaria Estimulación eléctrica transcutánea del nervio Neurología Tecnología médica Sistema endocrino 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. http://hdl.handle.net/11268/12451 |
| spellingShingle | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial Zapico, Álvaro Incontinencia urinaria Estimulación eléctrica transcutánea del nervio Neurología Tecnología médica Sistema endocrino |
| title | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial |
| title_full | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial |
| title_fullStr | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial |
| title_full_unstemmed | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial |
| title_short | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial |
| title_sort | Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial |
| topic | Incontinencia urinaria Estimulación eléctrica transcutánea del nervio Neurología Tecnología médica Sistema endocrino |
| topic_facet | Incontinencia urinaria Estimulación eléctrica transcutánea del nervio Neurología Tecnología médica Sistema endocrino |
| url | http://hdl.handle.net/11268/12451 |