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DE GRUYTER Current Directions in Biomedical Engineering 2022;8(3): 17-20 Janaina Tancredo*, Ivan Selegatto, Carlos Arturo Dancona, Alberto Cliquet Junior A feasibility study on the clinical use of non- invasive tibial nerve stimulation towards neurogenic bladder in spinal cord injured individuals Non- invasive tibial nerve stimulation on urinary incontinence https://doi.org/10.1515/cdbme-2022-2005 Keywords: Tibial nerve electrical stimulation, Tibial Nerve, Neurogenic Bladder, Spinal Cord Injury. Abstract: This research assesses the effect of tibial nerve electrical stimulation on urinary incontinence in individuals with spinal cord injury (SCI) being a prospective non- 1 Introduction controlled intervention study. 8 individuals with SCI were recruited from the outpatient clinic. This study demonstrates Low urinary tract dysfunction (neurogenic bladder) affects results of tibial nerve stimulation (TNS) applied to the tibial individuals with central and peripheral neurological diseases nerves for 12 weeks. Two questionnaires were applied [1,2]. The bladder is innervated by the hypogastric plexus, (Neurogenic Bladder Symptom Score-NBSS and Qualiveen- from T10 to L2-L4, containing only sympathetic fibers, and SF) and presented a tendency to improve symptoms and also by the pelvic plexus from S2 to S4, containing quality of life, however, without statistical significance. With sympathetic (hypogastric plexus) and parasympathetic fibers the urodynamic data: maximum cystometric capacity . increased with a mean of 285.6 ml pre, to 314.8 ml post TNS In neurogenic bladder (NB) alterations can be: normal (P-Value: 0.554); compliance increased from voiding pattern (bladder filling and emptying phases), 26.38ml/cmH2O pre TNS to 29.88ml/cmH2O post TNS (P- alteration of vesical sensitivity, increased intravesical Value: 0.461); detrusor hyperactivity in the filling phase pressure, incomplete voiding, inability to start or stop voiding occurred in all patients in the pre TNS assessment; the and incontinence . In normal bladder physiology, urine maximum amplitude of the detrusor pressure in mean detrusor storage and emptying are voluntary actions, where the overactivity after TNS increased from 62.0 to 66.6 cmH2 (P- reservoir has an adequate capacity, with low storage pressure Value: 0.674); urinary leakage pressure during detrusor and low urethral resistance . overactivity pre TNS were mean of 54.0 and 53.2 after (P- In spinal cord injury (SCI), there is an impairment of Value:1). The implications for rehabilitation practice and the communication between the brain and the urinary system, positive effects of TNS are fundamental to improving the where the elimination of urine is no longer controlled [3,4,5]. quality of life and reducing urinary incontinence on these NB affects quality of life, length of stay, health costs and individuals. Clinical outcomes, i.e., improvement on urinary especially the increased risk of urinary tract infection, which incontinence can be achieved within a short period of can lead to renal deterioration . The treatment for NB intervention. includes several interventions, such as catheterization (internal, intermittent and suprapubic) ; assisted bladder emptying; drug therapies; intravesical injection of botulinum toxin; surgery and electrical stimulation (neuromodulation) ______ [8,9]. *Corresponding author: Janaina Tancredo: State University of Regarding the validated questionnaires for spinal cord Campinas, Tessália Vieira de Camargo, 126, Campinas, Brazil, e- injury, we have the NBSS (Neurogenic Bladder Symptom mail: email@example.com Ivan Selegatto, Carlos Arturo Dancona: State University of Score)  and the Qualiveen –SF . One of the therapies Campinas, Campinas, Brazil used for neurogenic bladder is electrical stimulation of the Alberto Cliquet Junior: State University of Campinas, Campinas, tibial nerve. In 1983, McGuire et al.  described this type Brazil Open Access. © 2022 The Author(s), published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 International License. 17 of electrical stimulation as a minimally invasive treatment for another electrode (5x5cm) at a distance of 10 cm (positive urge urinary incontinence. Stampas et al. (2019) reported in electrode) [14,15], also in the medial region of the leg (see the preliminary study performed that transcutaneous electrical Figure 1). stimulation in individuals with acute spinal cord injury is able to achieve bladder neuromodulation. The study verified the effect of TNS on the tibial nerve in relation to urinary incontinence. The main objective was primarily for research, since there are few works of this nature in the scientific literature, proving or not the effectiveness of the use of TNS; and second, to provide greater security for the applicability of the TNS technique, aiming at a better quality Figure 1: Non- Invasive Tibial nerve stimulation (TNS) of life for these individuals and reducing the risk of urological complications. Two validated questionnaires were applied to this population: the NBSS and the Qualiveen –SF. These questionnaires are commonly used for urinary incontinence 2 Methods and to verify the quality of life of these individuals. Therefore, the developed protocol consisted of: A convenience sample of 8 individuals with SCI was 1) Urodynamic assessment for all recruited individuals recruited. All evaluations were performed Spinal Cord Injury (see Figure 2). All individuals stared TNS within 5 days of Rehabilitation Outpatient Clinic of the University Hospital. being through the urodynamic assessment. The study was approved by the local ethics committee (CAAE: 2) Application of 2 questionnaires validated for this 40799720.1.0000.5404). population and specific for NB (NBSS and Qualiveen -SF) The inclusion criteria were individuals with SCI, before starting treatment with the TNS protocol and after 12 diagnosed with paraplegia or tetraplegia (complete or sessions of it. incomplete), with frequent urine leakage and recurrent urinary 3) Application of the TNS protocol on the tibial nerve tract infection. In addition, individuals had to be young adults for 12 sessions , once a week, for 30 minutes. The TNS (over 18 years of age), with a diagnosis of SCI for more than application to the lower limbs bilateraly. The intensity was 1 year and not present any pathology that contraindicates adjusted until the beginning of muscle contraction (just above participation in the study. motor threshold). Individuals with urinary tract infection or any other type of 4) Re-ordering the Urodynamic assessment for all infection, those with urinary insufficiency in any other way, recruited individuals. recent urological surgery, normal control of voluntary At the end of the 12 weeks, a question was asked to the urination, malignant tumors, skin pathologies, patients using recruited individuals if they noticed an improvement or not in medication with antimuscarinics and mirabegron, women who the symptoms of incontinence. are menstruating or being pregnant, participation in other In the last application, the two questionnaires were also investigational drug or product research within the 30 days applied again. After 12 weeks , the urodynamics prior to and during the present study, neuromodulation assessment was performed again. treatment for urological or intestinal indication within the last 6 months or in progress, botulinum toxin injection in the last 6 3 Statistical analysis months, bilateral absence of the tibial nerve were excluded. For the application of the TNS protocols, a two-channel For the comparison between before and after TNS, for the custom made electrical stimulator was used at a frequency of continuous variables, the paired nonparametric Mann- 25 Hz, single-phase, with single-phase rectangular pulses with Whitney tests were used, because they did not follow a normal a duration of 300 μs, and an amplitude ranging from 70–150 distribution, verified by means of the Anderson-Darling test, V (1 kΩ load), up to 0.9 mA RMS, depending upon the and were homogeneous, verified by the Bartlett test. For individuals. Such intensity goes through skin fat tissue categorical variables, the McNemar test was used. In the impedance (capacitive) thus becoming a bipolare one. analysis of correlations between the variables, simple linear The self-adhesive surface electrodes (Valutrode, regression was used. The significance level adopted in the tests Axelgaard Manufacturing Co. Ltd., Fallbrook, CA, USA). was 0.05. Two-tailed hypotheses were considered. In addition, NMES were applied to the tibial nerve (L4 dermatome). The the confidence intervals constructed are 95%. R software exact locations of the electrodes were: one electrode (3 cm) at version 4.0.2 was used to perform all analyses. the height of the medial malleolus (negative electrode) and 4 Results Table 2: Urodynamic data of individuals. Outcomes Before and after the TNS protocol. Maximum cystometric capacity (MCC), compliance, detrusor overactivity (DO) in the bladder filling phase SCI characteristics of the individuals recruited (table 1). (FP), leakage pressure (LP) during DO, maximum DO amplitude (MA). Table 1: SCI characteristics. ____________________________________________________ ____________________________________________________ Individuals Variables Variables Individuals 1 2 3 4 5 6 7 8 MCC Compliance LP FP MA ____________________________________________________ ____________________________________________________ Level of injury T6-7 T6-7 T9-10 C6 C5 T6-7 T9-12 T1-2 1 Before 184 20 101 present 116 AIS T5B T5B T8A C6B C6B T5A T8A T4 D After 341 42 27 present 69 Bladder control No No No No No No No Yes 2 Before 303 23 78 present 98 Time post injury 4 15 13 16 17 19 4 8 After 400 36 absent absent absent (yrs) 3 Before 246 15 42 present 87 ___________________________________________________ After 231 19 54 present 69 4 Before 521 40 absent present 22 After 471 30 absent absent absent All recruited individuals were initially submitted to 5 Before 219 18 present present 18 urinalysis and urine culture. Five (62.5%) had bacterial growth After 394 32 58 present 32 before the first procedure and six (75%) before the second 6 Before 362 21 absent present 42 After 200 33 absent present 71 procedure. These findings of asymptomatic bacteriuria are 7 Before 150 37 14 present 38 very common in individuals who undergo clean intermittent After 182 30 80 present 86 catheterization. All of them used antibiotic therapy guided by 8 Before 300 37 18 present 18 After 300 17 47 present 47 the antibiogram result, at least 7 days before the urodynamic ___________________________________________________ evaluation. In addition, no individual developed urinary infection during the stimulation protocol. In the Maximum Cystometric Capacity (MCC) there was At the end of the 12 weeks of the TNS protocol, a question an increase with a mean of 285.6 ml pre, to 314.8 ml post TNS, was asked on the observation of the recruited individuals about without statistical significance (P-Value: 0.554). Analyzing the effect of the applied protocol. Five subjects (62.5%) the MCC in each patient separately, four (50%) had an reported improvement, one (12.5%) mild improvement and increase and one (12.5%) had no change. two (25%) did not notice improvement. Compliance showed an increase pre TNS from After the application of the TNS protocol, none of the 26.38ml/cmH2O to 29.88ml/cmH2O post TNS (P-Value: individuals reported side effects and complications, such as 0.461) without statistical significance. Likewise, when discomfort at the electrode application site, or skin changes. analyzed separately, five individuals (62.5%) show an Regarding the questionnaires applied, the NBSS, seven increase. In the filling phase, DO can occur, and it occurred in individuals performed clean intermittent catheterization all patients in the pre TNS evaluation. In the post TNS (87.5%) and only one individual used a collection evaluation, two (25%) of the eight individuals no longer bag/permanent catheter (12.5%). In all spheres of the presented this hyperactivity. Urinary leakage pressure during questionnaire, there was an improvement to the mean before DO pre TNS was a mean of 54.0 and 53.2 after (P-Value:1). and after the protocol; only in the storage that there was no In the maximum amplitude of the detrusor pressure, the improvement. mean post TNS increased from 62.0 to 66.6 cmH2 (P-Value: In the Qualiveen-SF questionnaire, all questions showed 0.674). Analyzing this variable separately, three (37.5%) had improvement, with the exception of the question about reduced amplitude and two (25%) had no more DO. With this Worrying about Limitations, where five individuals (62.5%) finding, it indicates an improvement of 62.5% in relation to the showed improvement, two individuals (25%) showed no pre TNS assessment. improvement and one (12.5%) remained the same answer on this question. Regarding the results found in this 5 Discussion questionnaire, there was a tendency towards quality of life improvement, however, without statistical significance (P- Value >0.05). Currently, it is believed that the stimulation of peripheral Regarding the urodynamic data analyzed and compared sensory afferent fibers block the lumbar and somatic sacral pre and post TNS were: maximum cystometric capacity afferent signals, responsible for the anomalous activity of the (MCC), compliance, detrusor overactivity (DO) in the bladder bladder, preventing the efferent reflexive motor response, filling phase (FP), leakage pressure (LP) during DO, which would result in detrusor hyperactivity and dyssynergia. maximum DO amplitude (MA). . McGuire et al (1983) was the first to report the Table 2 shows individuals’ outcomes. 19 effectiveness of applying direct electrical stimulation of the  Adams J, Watts R, Yearwood M, Watts A, Hartshorn C, tibial nerve in individuals with urge incontinence. Simpson S, et al. Strategies to promote intermittent self- Randomized clinical trials have evaluated the effect of catheterization in adults with neurogenic bladder: a electrical stimulation of the tibial nerve in individuals with comprehensive systematic review. JBI Libr System Rev. 2011; neurogenic bladder secondary to SCI. 9: 1392–446. In our study, we noticed a trend towards improvement in  Goetz LL, Cardenas DD, Kennelly M, Lee BSB, Linsenmeyer cystometric parameters. At initial cystometry, the individuals T, Moser C, et al. International spinal cord injury urinary tract in our study showed a decrease in the number of detrusor infection basic data set. Spinal Cord. 2013; 51:700-4. contractions, as well as an increase in the volume needed to [8 ] Blok B, Pannek Castro-Diaz JD, del Popolo G, Groen J, trigger them. In addition, in the initial cystometry, two Hamid R, Karsenty G, et al. EAU guidelines on neuro-urology. recruited individuals presented detrusor hyperactivity, but Eur Urol. 2015; 69: 324–33. after application of the protocol they did not present [9 ] Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, hyperactivity. We also verified that 75% of the individuals Hamid R, Karsenty G, Kessler TM, Schneider M, t Hoen L, noticed a subjective improvement with the treatment, and both Blok B. Summary of European Association of Urology (EAU) the NBSS questionnaire and the Qualiveen-SF had a tendency Guidelines on Neuro-Urology. Eur Urol. 2016; 69(2):324–333. to improve the total score.  Welk B, Lenherr S, Elliott S, Stoffel J, Presson AP, Zhang C, Therefore, with all these findings, transcutaneous tibial Myers JB. The neurogenic bladder Symptom Score (NBSS): a electrostimulation might be an option as a form of treatment secondary assessment of its validity, reliability among with a for these individuals, but further studies are needed with a spinal cord injury. Spinal Cord. 2018; 56:259-264. larger sample and/or with the possibility of increasing the  Cintra LKL, de Bessa J, Kawahara VI, Ferreira TPA, Srougi number of applications. M, Battistella LR, et al. Cross-cultural adaptation and validation of the neurogenic bladder symptom scoring Author Statement questionnaire into Brazilian Portuguese. Int braz j urol. May 2, Research funding: The author state no funding involved. 2019; 45. Conflict of interest: Authors state no conflict of interest.  McGuire EJ, Shi-chun Z, Horwinski ER, Lytton B. Treatment Informed consent: Informed consent has been obtained from of motor and sensory detrusor instability by electrical all individuals included in this study. Ethical approval: The stimulation. J Urol. 1983;129(1):78-79. research related to human use complies with all the relevant  Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. national regulations, institutional policies and was performed Bladder Neuromodulation in Acute Spinal Cord Injury via in accordance with the tenets of the Helsinki Declaration, and Transcutaneous Tibial Nerve Stimulatio: cystometrogram and has been approved by the authors' institutional review board or Autonomic Nervous System Evidence From a Randomized equivalent committee. Control Pilot Trial. Front. Neurosci.2019; 13: 119.  Bride AA, Tailor V, Fernando R, Khullar V, Digesu GA. References Posteriortibial nerve stimulation for overactive bladder- techniques and efficacy. International Urogynecology Journal,  Diniz MSC. Neurological Diseases and the Urinary Tract.In: 2020; 31:865-870. Girão, et al. Treatise on Urogynecology and Pelvic Floor  Welk B, Mckibbon M. A randomized, controlled trial of Disorders. 1st ed. 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Current Directions in Biomedical Engineering – de Gruyter
Published: Sep 1, 2022
Keywords: Tibial nerve electrical stimulation; Tibial Nerve; Neurogenic Bladder; Spinal Cord Injury
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