throbber
0022-5347/03/1696-2210/0
`THE JOURNAL OF UROLOGY®
`Copyright © 2003 by AMERICAN UROLOGICAL ASSOCIATION
`
`Vol. 169, 2210 –2215, June 2003
`Printed in U.S.A.
`DOI: 10.1097/01.ju.0000067446.17576.bd
`
`URODYNAMIC EFFECT OF ACUTE TRANSCUTANEOUS POSTERIOR
`TIBIAL NERVE STIMULATION IN OVERACTIVE BLADDER
`
`G. AMARENCO, S. SHEIKH ISMAEL, A. EVEN-SCHNEIDER, P. RAIBAUT, S. DEMAILLE-WLODYKA,
`B. PARRATTE AND J. KERDRAON
`From the Department of Neurologic Rehabilitation, Urodynamic and Neurophysiology Laboratory. Hoˆpital Rothschild, Assistance
`Publique-Hoˆpitaux de Paris, Paris, France
`
`ABSTRACT
`Purpose: Of the various treatments proposed for urge incontinence, frequency and urgency
`electrostimulation has been widely tested. Different techniques have been used with the neces-
`sity of surgical implantation (S3 neuromodulation or sacral root stimulation) or without requir-
`ing surgery (perineal transcutaneous electrostimulation). Recently peripheral electrical stimu-
`lation of the posterior tibial nerve was proposed for irritative symptoms in first intention or for
`intractable incontinence. Clinical studies have demonstrated good results and urodynamic pa-
`rameters were improved after chronic treatment. However, to our knowledge no data concerning
`acute stimulation and immediate cystometry modifications have been reported. We verified
`urodynamic changes during acute posterior tibial nerve stimulation.
`Materials and Methods: A total of 44 consecutive patients with urge incontinence, frequency
`and urgency secondary to overactive bladder were studied. There were 29 women and 15 men
`with a mean age ⫾SD of 53.3 ⫾ 18.2 years. Of the patients 37 had detrusor hyperreflexia due to
`multiple sclerosis (13), spinal cord injury (15) or Parkinson’s disease (9), and 7 had idiopathic
`detrusor instability. Routine cystometry at 50 ml. per minute was done to select the patients with
`involuntary detrusor contractions appearing before 400 ml. maximum filling volume. Repeat
`cystometry was performed immediately after the first study during left posterior tibial nerve
`stimulation using a surface self-adhesive electrode on the ankle skin behind the internal malle-
`olus with shocks in continuous mode at 10 Hz. frequency and 200 milliseconds wide. Volume
`comparison was done at the first involuntary detrusor contraction and at maximum cystometric
`capacity. The test was considered positive if volume at the first involuntary detrusor contraction
`and/or at maximum cystometric capacity increased 100 ml. or 50% during stimulation in com-
`pared with standard cystometry volumes.
`Results: Mean first involuntary detrusor contraction volume on standard cystometry was
`162.9 ⫾ 96.4 ml. and it was 232.1 ⫾ 115.3 ml. during posterior tibial nerve stimulation. Mean
`maximum cystometric capacity on standard cystometry was 221 ⫾ 129.5 ml. and it was 277.4 ⫾
`117.9 ml. during stimulation. Posterior tibial nerve stimulation was associated with significant
`improvement in first involuntary detrusor contraction volume (p ⬍0.0001) and significant im-
`provement in maximum cystometric capacity (p ⬍0.0001). The test was considered positive in 22
`of the 44 patients.
`Conclusions: These results suggest an objective acute effect of posterior tibial nerve stimula-
`tion on urodynamic parameters. Improved bladder overactivity is an encouraging argument to
`propose posterior tibial nerve stimulation as a noninvasive treatment modality in clinical
`practice.
`
`KEY WORDS: electrical stimulation, urodynamics, tibial nerve, urinary incontinence
`
`For many years peripheral electrical stimulation has been
`widely used to treat urinary disorders.1– 4 Different stimula-
`tion modalities for various pathological conditions were
`tested. Chronic perineal muscles stimulation proved to be
`safe and effective for stress urinary incontinence.1 Acute
`perineal nerve stimulation (dorsal nerve of the penis) was
`effective for decreasing detrusor hyperreflexia in spinal cord
`injury cases.5 Chronic electrical stimulation of perineal skin/
`sacral dermatomes was used to manage urge incontinence
`and many studies have had good and consistent results.4, 6 – 8
`Recently sacral neuromodulation with surgical implantation
`of an S3 stimulator was proposed to treat various urinary
`symptoms, especially intractable urge incontinence and uri-
`nary frequency. More recently posterior tibial nerve stimu-
`lation has been used as a chronic treatment to improve urge
`Accepted for publication January 17, 2003.
`
`incontinence and frequency.9, 10 Surprisingly sparse urody-
`namic data on the efficacy of chronic posterior tibial nerve
`stimulation are available. Moreover, urodynamic parameters
`evaluations have only been reported before and after chronic
`treatment with posterior tibial nerve stimulation.9 Indeed, to
`our knowledge no study has been performed to determine
`urodynamic effects following acute posterior tibial nerve
`stimulation. We studied by urodynamic investigation possi-
`ble detrusor activity modifications during acute tibial nerve
`stimulation in a population presenting with symptoms (urge
`incontinence and frequency) secondary to overactive bladder.
`
`MATERIAL AND METHODS
`Study design and subjects. The study group consisted of 44
`patients with a history of voiding dysfunction. There were 29
`women and 15 men with a mean age ⫾SD of 53.3 ⫾ 18.2
`2210
`
`Copyright © American Urological Association. Unauthorized reproduction of this article is prohibited.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1005, p. 2210
`
`

`

`URODYNAMIC EFFECT OF TIBIAL NERVE STIMULATION
`
`2211
`
`years. All patients had irritative symptoms with urge incon-
`tinence, urgency and frequency. These patients had demon-
`strable overactive bladder on routine cystometry with invol-
`untary detrusor contraction appearing before 400 ml.
`maximum filling volume. The etiology was multiple sclerosis
`13 cases, spinal cord injury in 15, brain lesion (brain injury,
`stroke or Parkinson’s disease) in 9 and idiopathic instability
`in 7 without apparent neurological disease. All patients pro-
`vided a clinical history and underwent examination, urinal-
`ysis and urodynamic studies. All patients provided consent to
`participate in the study. The study was approved by the local
`ethics committee.
`Procedure. The urodynamic methodology complied with
`International Continence Society recommendations. Cystom-
`etry was performed with the patient supine through a double
`lumen 8Fr catheter with computerized analysis of results.
`Cystometry was done using normal saline at 25C to 30C. The
`filling rate was 50 ml. per minute. The study inclusion crite-
`rion was involuntary detrusor contraction during the filling
`procedure before 400 ml. maximum cystometric volume. Wa-
`ter filling was stopped if leakage occurred or a cystometric
`volume of 400 ml. was achieved. Volume at the first involun-
`tary detrusor contraction and at maximum cystometric ca-
`pacity were noted.
`Repeat cystometry at a 50 ml. per minute filling rate was
`performed immediately after posterior tibial nerve stimula-
`tion. Stimulation was done using a self-adhesive surface
`stimulation electrode without an implanted needle electrode.
`Contact electrodes were placed with electrode gel on the
`ankle skin with the negative electrode behind the internal
`malleolus and the positive electrode 10 cm. above the nega-
`tive electrode. The correct position of the negative electrode
`was determined by visualization of rhythmic flexion of the
`toes secondary to plantar muscle contraction during stimu-
`lation delivered at 1 hz. The intensity level was then chosen
`as the intensity immediately under the threshold determin-
`ing motor contraction. In addition, no pain was to be noted
`during the stimulation procedure, which necessarily had to
`be comfortable for the patient. Stimulation frequency during
`cystometry was then applied at 10 Hz. and a pulse width of
`200 milliseconds in continuous mode. This second cystometry
`during posterior tibial nerve stimulation was started imme-
`diately after determining the chosen stimulation. Neuro-
`stimulation was continuous during the whole second study.
`
`A comparison was done between volume at the first invol-
`untary detrusor contraction and at maximum cystometric
`capacity for standard cystometry and for cystometry during
`posterior tibial nerve stimulation. If on the second cystom-
`etry during stimulation the first involuntary detrusor con-
`traction occurred at a volume that was 100 ml. or 50% more
`than the first involuntary detrusor contraction volume on
`standard cystometry, the test was considered positive (fig. 1).
`Likewise the test was also considered positive if maximum
`cystometric capacity following posterior tibial nerve stimula-
`tion increased more than 100 ml. or more than 50% volume
`compared with standard cystometry. Otherwise the test was
`considered negative. For statistical study of different associ-
`ations the Student test for patient age, and volume at the
`first involuntary detrusor contraction and at maximum cys-
`tometric capacity was used with significance considered at
`p ⬍0.01.
`
`RESULTS
`Mean first involuntary detrusor contraction on standard
`cystometry was 162.9 ⫾ 96.4 ml., while it was 232.1 ⫾ 115.3
`ml. during posterior tibial nerve stimulation (table 1, fig. 1).
`Mean maximum cystometric capacity on standard cystom-
`etry was 221 ⫾ 129.5 ml., while it was 277.4 ⫾ 117.9 ml.
`during stimulation (table 1, fig. 2). During stimulation im-
`provement was significant for the first involuntary detrusor
`contraction and for maximum cystometric capacity (each
`p ⬍0.0001).
`Regarding the increase of more than 50% in first involun-
`tary detrusor contraction volume during stimulation com-
`pared with standard cystometry the test was positive in 21 of
`
`TABLE 1. Urodynamic parameters before and during posterior
`tibial nerve stimulation in 44 patients with overactive bladder
`Mean Vol. ⫾ SD (range) (ml.)
`
`First involuntary detrusor contraction:
`Baseline
`Posterior tibial nerve stimulation
`Max. cystometric capacity:
`Baseline
`Posterior tibial nerve stimulation
`* Student test p ⬍0.0001.
`
`162.9 ⫾ 96.4
`(2–375)
`232.1 ⫾ 115.3 (55–400)*
`
`221 ⫾ 129.5 (14–400)
`277.4 ⫾ 117.9* (70–400)
`
`450
`
`400-
`
`350-
`
`300-
`
`250-
`
`200
`
`150-
`
`100
`
`50
`
`0
`
`1st IbC baseline
`
`1st IDd PTN
`
`FIG. 1. Improvement in bladder volume at first involuntary detru-
`sor contraction (1st IDC) following surface stimulation with 10 Hz.
`for 200 milliseconds of posterior tibial nerve (PTN) at ankle during
`mid fill cystometry in patients with overactive bladder (Student test
`p ⬍0.0001).
`
`450
`
`400-
`
`350-
`
`300-
`
`250-
`
`200-
`
`150-
`
`100-
`
`50-
`
`0
`
`MCC baseline
`
`MCC PINS
`
`FIG. 2. Improvement in maximum cystometric capacity (MCC)
`following surface stimulation with 10 Hz. for 200 milliseconds of
`posterior tibial nerve (PTN) at ankle during mid fill cystometry in
`patients with overactive bladder (Student test p ⬍0.0001).
`
`Petitioner - Avation Medical, Inc.
`Ex. 1005, p. 2211
`
`

`

`2212
`
`URODYNAMIC EFFECT OF TIBIAL NERVE STIMULATION
`
`Cyst. PR 50nnl
`
`MG#1
`
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`
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`cm H2O
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`FIG. 3. Standard cystometry in 42-year-old patient with multiple sclerosis presenting with urge incontinence, frequency and urgency
`shows overactive bladder with noninhibited detrusor contraction.
`
`T
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`
`-Jo N\ wki\AWIN 1\11 ptri
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`MP.
`FIG. 4. Cystometry following surface stimulation with 10 Hz. of posterior tibial nerve at ankle demonstrates improvement in urodynamic
`parameters with suppression of involuntary detrusor contractions.
`
`the 44 cases (figs. 3 and 4). Regarding the increase of more
`than 100 ml. in first involuntary detrusor contraction volume
`during stimulation, the test was positive in 13 cases. Regard-
`ing the improvement of more than 50% of maximum cysto-
`metric capacity during posterior tibial nerve stimulation, the
`test was positive in 15 cases. Regarding improvement of more
`than 100 ml. of first involuntary detrusor contraction volume
`during stimulation, the test was positive in 11 cases. Globally
`with 1 at least of the 4 previous criteria the test was consid-
`ered positive in 22 cases (50%). Only 1 patient had improved
`maximum cystometric capacity without an increase in first
`involuntary detrusor contraction volume of more than 100
`ml. or 50%.
`
`DISCUSSION
`Patients with irritative symptoms such as frequency,
`urgency and urge incontinence secondary to detrusor in-
`stability or hyperreflexia are habitually treated with anti-
`cholinergic drugs. However, in some patients anticholin-
`
`ergic drugs may have no efficacy for urinary symptoms
`immediately or after months of treatment. Moreover, these
`drugs may have side effects (dry mouth, constipation, blur-
`ring eyes, hesitancy or urinary retention), which can lead
`to the cessation of treatment despite its efficacy. Finally
`detrusor overactivity may persist despite treatment with a
`high risk of reflux or renal complications in neurologic
`cases. In all of these cases alternative therapeutic solu-
`tions have been proposed before bladder augmentation,
`such as bladder training and perineal electrical stimula-
`tion. Recently local drug treatments have been tested,
`including intravesical instillation of capsaicin or resinif-
`eratoxin and and botulinum-A toxin injections into the
`detrusor. Meanwhile, these treatments are actually only
`proposed in neurological cases, especially spinal cord in-
`jury with intractable overactivity, which can lead to ure-
`teral reflux and kidney damage. Moreover, these treat-
`ments are only available for pharmaceutical trials and
`need invasive protocols.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1005, p. 2212
`
`

`

`URODYNAMIC EFFECT OF TIBIAL NERVE STIMULATION
`
`2213
`
`The use of electrostimulation to improve bladder storage
`capacity has a long history. Various types of neurostimula-
`tion have been tried for urge incontinence treatment, fre-
`quency and urgency but also for stress urinary incontinence.
`Sacral anterior root stimulation and S3 neuromodulation11
`have been well evaluated with real benefits of these devices
`for bladder overactivity control. These techniques are safe
`and effective but they require surgical implantation and a
`test period, which can limit their use. Pudendal nerve stim-
`ulation, anal or vaginal stimulation and more generally sur-
`face stimulation on the perineal area have been evaluated for
`various conditions, such as stress urinary incontinence and
`irritative symptoms. Many clinical studies have demon-
`strated their efficacy to decrease incontinence episodes, uri-
`nary frequency and urge sensation, and increase bladder
`capacity4, 6, 7, 12–14 using quality of life instruments, and fre-
`quency and volume charts.
`On the other hand, urodynamic studies of the effects of
`chronic electrostimulation are less frequent (table 2).6, 8, 12–15
`Various sites of stimulation have been tested (perianal skin,
`sphincter stimulation, dorsal penile or clitoris nerve, quadri-
`ceps and hamstring muscles) and different types of patients
`have been studied with idiopathic detrusor instability or
`detrusor hyperreflexia, especially concerning spinal cord in-
`jury. Thus, transcutaneous electrical stimulation applied to
`the perianal skin has been demonstrated to be efficacious for
`abolishing detrusor instability and increasing mean volume
`at first bladder sensation and mean total bladder capaci-
`ty.6, 14, 15 Meanwhile, other studies have not shown signifi-
`cant changes in cystometric findings after chronic electro-
`stimulation
`(volume
`at
`first
`involuntary
`detrusor
`contraction, duration of phasic contractions or bladder capac-
`ity).8, 12, 13 However, clinical improvements were noted in
`these studies, including increased functional capacity, de-
`
`creased daily number of voids and improved quality of life
`measures.8, 13
`The urodynamic effects of acute electrical stimulation on
`detrusor activity is also less reported (table 3).5, 6, 16 –20 De-
`trusor hyperreflexia in patients with chronic suprasacral
`spinal cord injury has especially been studied.5, 16, 19, 20 Sig-
`nificant differences in bladder capacity were found during
`electrostimulation of the dorsal penile or clitoris nerve via
`surface electrodes5 and during percutaneous sacral nerve
`neurostimulation.19 Bladder volume at first uninhibited con-
`traction was also increased and maximum detrusor pressure
`during uninhibited contractions decreased during sacral root
`stimulation.19 Noninvasive third sacral nerve (S3) stimula-
`tion and its acute effect on urodynamic parameters were also
`tested.16 Transcutaneous electrical stimulation was applied
`on the skin overlying S3 dermatomes (junction of the buttock
`and upper thigh) and a statistically significant increase in
`bladder storage capacity without a corresponding decrease in
`detrusor pressure was observed in the 74 neurostimulated
`patients.16 Electrical current was also delivered to the supra-
`pubic region and third sacral foramen via a transcutaneous
`electrical nerve stimulator. A decreased mean maximum am-
`plitude of detrusor contraction was noted.17
`McGuire et al were the first to report the efficacy of direct
`electrical stimulation of the posterior tibial nerve in patients
`with urge incontinence.4 More recently several studies have
`been done to evaluate intermittent percutaneous posterior
`tibial nerve stimulation as a treatment in patients who pre-
`sented with symptoms of bladder overactivity (urgency and
`frequency syndrome, and/or urge incontinence).9, 10 A statis-
`tically significant decrease was observed in leakage episodes,
`the number of pads used, voiding frequency and nocturia,
`and an equal increase in the mean and smallest volumes
`voided. Two-thirds of the cases were classified as treatment
`
`TABLE 2. Literature on chronic effect of electrostimulation
`
`References
`
`No.
`Pts.
`
`Electrostimulation Modality
`
`Disease (No. pts.)
`
`% Overactivity
`Suppression
`
`Increase (No. pts.)
`First Uninhibited
`Contraction
`
`Max. Capacity
`
`21
`13
`
`Perianal skin
`Sphincter stimulation 12 days, 30
`mins. twice daily
`19 Quadriceps ⫹ hamstring muscles,
`20 mins./day, 14 days
`6 Dorsal penile or clitoris nerve
`15
`Stoller afferent nerve stimulator
`4–15 mos.
`Perianal region
`
`43
`
`Detrusor instability
`Detrusor hyperreflexia
`
`Detrusor instability (5)
`Detrusor hyperreflexia (14)
`Detrusor hyperreflexia
`Detrusor instability
`
`Detrusor instability
`
`62
`0
`
`—
`
`0
`76.9
`
`0
`
`—
`0
`
`Greater than 50% (11/19)
`
`0
`197 to 252 Ml. (15/15)
`
`0
`
`—
`0
`
`0
`
`0
`
`Nakamura et al6
`Petersen et al13
`
`Okada et al15
`
`Previnaire et al12
`Klingler et al14
`
`Soomro et al8
`
`References
`
`Electrostimulation Site
`
`Disease
`
`Main Results
`
`TABLE 3. Literature on acute effect of electrostimulation
`No.
`Pts.
`25
`
`Nakamura et al7
`
`Perianal skin
`
`Previnaire et al5
`
`Bower et al17
`
`Yamanishi et
`al18
`
`Chartier-Kastler
`et al19
`
`Walsh et al16
`
`Lee and
`Creasey20
`
`Dorsal penile or clitoris nerve
`surface electrodes
`Suprapubic region ⫹ third sacral
`foramina
`Vaginal electrode or surface
`electrode on dorsal part of penis
`
`Sacral neurostimulation (S3)
`
`Transcutaneous electrical stimula-
`tion of third sacral nerve (skin
`overlying S3 dermatomes, junc-
`tion of buttock and upper thigh)
`Dorsal nerve of penis
`
`10
`
`33
`
`14
`
`74
`
`1
`
`Frequency, urgency or
`incontinence
`Spinal cord injury
`
`Inhibition of detrusor instability in 4/8 pts. ⫹ increased
`max. cystometric capacity in 5/25
`Significant increase in bladder capacity vs. baseline
`(318.5 vs. 155.5 ml., p ⬍0.007)
`Decreased mean max. detrusor contraction wt.
`
`Detrusor overactivity
`
`Spinal cord injury
`
`Idiopathic instability,
`multiple sclerosis ⫹
`spinal cord injury
`
`Bladder capacity at first desire to void ⫹ max. cysto-
`metric capacity increased significantly during
`stimulation (p ⫽ 0.0015 ⫹ 0.0229, respectively)
`Statistically significant differences in max. bladder
`capacity (206.8 ml.), bladder vol. at first uninhibited
`contraction (151.5 ml.) ⫹ max. detrusor pressure
`during uninhibited contractions (⫺23.4 cm. H2O)
`Max. cystometric capacity increased significantly during
`stimulation (p ⫽ 0.0002)
`
`Incomplete spinal cord
`injury
`
`Suppressive effect of electric stimulation on hyperreflexic
`contractions
`
`Petitioner - Avation Medical, Inc.
`Ex. 1005, p. 2213
`
`

`

`2214
`
`URODYNAMIC EFFECT OF TIBIAL NERVE STIMULATION
`
`successes. In these studies stimulation was delivered using a
`34 gauge stainless steel needle inserted about 3 finger
`breadths cephalad to the medial malleolus, between the pos-
`terior margin of the tibia and soleus muscle. We chose an-
`other technique that is less invasive using disposable, self-
`adhesive contact electrodes. This technique is cheap,
`noninvasive and free of pharmaceutical side-effects. More-
`over, stimulation outside of the anogenital region has higher
`acceptance by patients.
`In our series a significant statistical difference was noted
`between the 2 groups but there were many failures. Compar-
`isons in specific groups (hyperreflexia versus instability,
`multiple sclerosis versus spinal cord injury, male versus fe-
`male and so forth, failed to reveal significance. This finding
`was probably due to poor patients homogeneity, including
`neuropathic and nonneuropathic groups. The second reason
`is that many patients had severe detrusor overactivity with
`low detrusor capacity. This severe detrusor overactivity may
`be less sensitive to posterior tibial nerve stimulation. In the
`methodology we chose the limit of 400 ml. maximum filling to
`standardize the procedure and avoid difficult interpretation
`of bladder overactivity at high capacities. Another remark
`concerns the possible effect of habituation due to repeat cys-
`tometry on the recorded increase in urodynamic volume pa-
`rameters. This effect is possible and other studies are neces-
`sary to determine its interference.
`Posterior tibial nerve stimulation inhibits bladder activity
`by depolarizing somatic sacral and lumbar afferent fibers.2
`Afferent stimulation provides central
`inhibition of
`the
`preganglionic bladder motor neurons through a direct route
`in the sacral cord.1 Meanwhile, the neuromodulation of the
`micturition reflex allowed by posterior tibial nerve stimula-
`tion remains unclear. Modification of perineal spasticity may
`be one of the different mechanisms involved in neurological
`cases. Indeed, the effect of afferent cutaneous electrical stim-
`ulation on the spasticity of leg muscles is well known. Trans-
`cutaneous electrical nerve stimulation at the usual intensity
`only stimulates sensory fibers. This technique is widely used
`for pain management and many commercial devices are
`available. Transcutaneous electrical nerve stimulation ap-
`plied to the sural nerve may induce short-term post-
`stimulation inhibitory effects on abnormally enhanced
`stretch reflex activity in patients with spasticity of cerebral
`origin. Likewise, transcutaneous electrical nerve stimulation
`applied in those with spastic hemiparesis caused an imme-
`diate increase in soleus H reflex latencies that was evident
`for up to 60 minutes after stimulation in more than 75%. The
`short-term effects of transcutaneous electrical nerve stim-
`ulation on the H reflex and spinal spasticity was evaluated
`in spinal cord injured subjects. Although statistical anal-
`yses failed to reveal significant effects of transcutaneous
`electrical nerve stimulation on H reflex amplitude, there
`was a significant decrease in scores for the Achilles tendon
`reflex and the modified Ashworth test. In spastic cases the
`mean peak-to-peak amplitude of H reflexes, F waves, H/M
`and F/M ratios were significantly decreased and the mean
`latencies of H reflexes and F waves were significantly
`increased after the application of transcutaneous electrical
`nerve stimulation. Other studies have suggested an indi-
`rect action of transcutaneous electrical nerve stimulation
`on the central nervous system, especially a modification on
`the dorsal column-medial lemniscal pathway. When trans-
`cutaneous electrical nerve stimulation was applied to the
`palm distal to the median nerve stimulation used for so-
`matosensory evoked potentials, cortical N20/P25 amplifi-
`cation disappeared, evidence that transcutaneous electri-
`cal nerve stimulation suppresses the central amplification
`phenomenon, most probably at the level of the cuneate
`nucleus. A modification of somatovisceral reflexes can be
`discussed, as previously described for gastric electrical
`activity modified by transcutaneous electrical nerve stim-
`
`ulation and evaluated by gastric myoelectric activity meas-
`ured by electrogastrography.
`
`CONCLUSIONS
`Posterior tibial nerve stimulation is a minimally invasive
`technique that can suppress detrusor instability or hyperre-
`flexia. Improved bladder capacity is an encouraging finding
`that further supports its use as a noninvasive treatment
`modality in clinical practice. However, there is no argument
`in this study suggesting that posterior tibial nerve stimula-
`tion may predict S3 neuromodulation failure. Thus, S3 neu-
`romodulation remains indicated in patients in whom poste-
`rior tibial nerve stimulation has failed. Furthermore,
`posterior tibial nerve stimulation may be proposed as a test
`to select candidates for definitive S3 neuromodulation, which
`is simpler than the several days of clinical evaluation follow-
`ing an S3 stimulation test. However, further studies are
`required to test this hypothesis.
`
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`tients? Spinal Cord, 36: 100, 1998
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`Copyright © American Urological Association. Unauthorized reproduction of this article is prohibited.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1005, p. 2214
`
`

`

`URODYNAMIC EFFECT OF TIBIAL NERVE STIMULATION
`
`2215
`
`storage. Neurourol Urodyn, 20: 73, 2001
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`T., Ito, H. et al: Comparative study of the effects of magnetic
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`tivity. Urology, 56: 777, 2000
`
`19. Chartier-Kastler, E. J., Denys, P., Chancellor, M. B., Haertig, A.,
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`2002
`
`Copyright © American Urological Association. Unauthorized reproduction of this article is prohibited.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1005, p. 2215
`
`

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