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...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-01-01
|
| Series: | Journal of Clinical Medicine |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2077-0383/12/3/759 |
| _version_ | 1797624166016352256 |
|---|---|
| author | Álvaro Zapico Julia Ercilla Javier C. Angulo Vicente Pérez Juan Nicolás Cuenca Diana Barreira-Hernández Carlos Udina-Cortés |
| author_facet | Álvaro Zapico Julia Ercilla Javier C. Angulo Vicente Pérez Juan Nicolás Cuenca Diana Barreira-Hernández Carlos Udina-Cortés |
| author_sort | Álvaro Zapico |
| collection | DOAJ |
| 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 (<i>p</i> = 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 (<i>p</i> < 0.001), and at 6 months in 18 (55%) vs. 11 (33%) (<i>p</i> = 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 (<i>p</i> = 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 (<i>p</i> = 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. |
| first_indexed | 2024-03-11T09:39:15Z |
| format | Article |
| id | doaj.art-c43cc21c80c3420ba91df4d28d91ffee |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-11T09:39:15Z |
| publishDate | 2023-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-c43cc21c80c3420ba91df4d28d91ffee2023-11-16T17:06:48ZengMDPI AGJournal of Clinical Medicine2077-03832023-01-0112375910.3390/jcm12030759Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded TrialÁlvaro Zapico0Julia Ercilla1Javier C. Angulo2Vicente Pérez3Juan Nicolás Cuenca4Diana Barreira-Hernández5Carlos Udina-Cortés6Department of Obstetrics and Gynecology, Hospital Universitario Príncipe de Asturias, 28802 Alcalá de Henares, SpainDepartment of Obstetrics and Gynecology, Hospital Universitario Príncipe de Asturias, 28802 Alcalá de Henares, SpainDepartment of Urology, Hospital Universitario de Getafe, 28905 Getafe, SpainDepartment of Obstetrics and Gynecology, Hospital Universitario Príncipe de Asturias, 28802 Alcalá de Henares, SpainNursing and Physiotherapy Department, Universidad de Alcalá, 28802 Alcalá de Henares, SpainDepartment of Biomedical Sciences, Universidad de Alcalá, 28802 Alcalá de Henares, SpainInstitute Neurolife, 28034 Madrid, SpainThis 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 (<i>p</i> = 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 (<i>p</i> < 0.001), and at 6 months in 18 (55%) vs. 11 (33%) (<i>p</i> = 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 (<i>p</i> = 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 (<i>p</i> = 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.https://www.mdpi.com/2077-0383/12/3/759overactive bladderurinary incontinenceneuromodulationneurostimulationneuro-adaptive therapySCENAR |
| spellingShingle | Álvaro Zapico Julia Ercilla Javier C. Angulo Vicente Pérez Juan Nicolás Cuenca Diana Barreira-Hernández Carlos Udina-Cortés Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial Journal of Clinical Medicine overactive bladder urinary incontinence neuromodulation neurostimulation neuro-adaptive therapy SCENAR |
| 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 | overactive bladder urinary incontinence neuromodulation neurostimulation neuro-adaptive therapy SCENAR |
| url | https://www.mdpi.com/2077-0383/12/3/759 |
| work_keys_str_mv | AT alvarozapico effectofneuroadaptiveelectrostimulationtherapyversusshamforrefractoryurgeurinaryincontinenceduetooveractivebladderarandomizedsingleblindedtrial AT juliaercilla effectofneuroadaptiveelectrostimulationtherapyversusshamforrefractoryurgeurinaryincontinenceduetooveractivebladderarandomizedsingleblindedtrial AT javiercangulo effectofneuroadaptiveelectrostimulationtherapyversusshamforrefractoryurgeurinaryincontinenceduetooveractivebladderarandomizedsingleblindedtrial AT vicenteperez effectofneuroadaptiveelectrostimulationtherapyversusshamforrefractoryurgeurinaryincontinenceduetooveractivebladderarandomizedsingleblindedtrial AT juannicolascuenca effectofneuroadaptiveelectrostimulationtherapyversusshamforrefractoryurgeurinaryincontinenceduetooveractivebladderarandomizedsingleblindedtrial AT dianabarreirahernandez effectofneuroadaptiveelectrostimulationtherapyversusshamforrefractoryurgeurinaryincontinenceduetooveractivebladderarandomizedsingleblindedtrial AT carlosudinacortes effectofneuroadaptiveelectrostimulationtherapyversusshamforrefractoryurgeurinaryincontinenceduetooveractivebladderarandomizedsingleblindedtrial |