Accepted Manuscript Effects of transcutaneous neuromodulation (TENS) on overactive bladder symptoms in children: A randomized controlled trial U. Sillén , MD PhD C. Arwidsson , M. Doroszkiewicz , H. Antonsson , I. Jansson , M. Stålklint , K. Abrahamsson , S. Sjöström PII:

S1477-5131(14)00137-5

DOI:

10.1016/j.jpurol.2014.03.017

Reference:

JPUROL 1695

To appear in:

Journal of Pediatric Urology

Received Date: 4 January 2014 Accepted Date: 30 March 2014

Please cite this article as: Sillén U, Arwidsson C, Doroszkiewicz M, Antonsson H, Jansson I, Stålklint M, Abrahamsson K, Sjöström S, Effects of transcutaneous neuromodulation (TENS) on overactive bladder symptoms in children: A randomized controlled trial, Journal of Pediatric Urology (2014), doi: 10.1016/ j.jpurol.2014.03.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

*edited manuscript (excluding author details) Click here to view linked References

ACCEPTED MANUSCRIPT Effects of transcutaneous neuromodulation (TENS) on overactive bladder symptoms in children: A randomized controlled trial U. Sillén U a,*, C. Arwidsson a, M. Doroszkiewicz a, H. Antonsson b, I. Jansson c, M. Stålklint

a

, K. Abrahamsson a, S. Sjöström a Pediatric Uronephrology Center, The Queen Silvia Children’s Hospital, Sahlgrenska

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d

b

SÄS, Västra Götaland Region, Sweden

c

NÄL, Västra Götaland Region, Sweden

d

KSS, Västra Götaland Region, Sweden

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University Hospital, Gothenburg, Sweden

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* Corresponding author: Pediatric Uronephrologic Center, The Queen Silvia Children’s Hospital, 416 85 Gothenburg, Sweden. Tel.: +46313434658 E-mail address: [email protected] (U Sillén).

Abstract Background: The aim of the present study was to investigate whether addition of

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transcutaneous electrical nerve stimulation (TENS) treatment improves the results of standard urotherapy in children with overactive bladder (OAB) symptoms. Material and methods: Sixty-two children with symptoms of OAB and incontinence were

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included. The children were randomized either to standard urotherapy treatment alone or a combination of standard urotherapy and TENS. The effect variables were taken from a

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voiding–drinking diary: number of voiding, number of incontinence episodes, and maximum voided volume.

Results: Both treatment groups had good treatment results, with no significant difference between the groups. In the standard treatment group 13/28 (46%) were completely dry and 11/28 (40%) had a decrease in incontinence episodes, compared to 16/24 (67%) and 3/24 (13%), respectively, in the standard + TENS group (p = 0.303). The number of voiding decreased in two-thirds of the patients in both groups. However, maximal voided volume only

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ACCEPTED MANUSCRIPT increased in the standard treatment group. Subjectively 72% and 80% considered themselves significantly improved or free of symptoms. Previous treatment was registered in 15/55 (27%). All efficacy variables decreased in those with previous treatment, but with no difference between the standard and standard + TENS treatment groups. The only difference

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noted was when comparing the children without previous treatment in the groups: a

significantly higher proportion were completely dry in the TENS group (12/18 [71%] versus 10/22 [48%], p = 0.05)

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Conclusion: Our results showed no significant difference overall in treatment response to OAB symptoms between urotherapy only and urotherapy + TENS, whereas a tendency to

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difference was found in children without previous treatment. Thus with good urotherapy support, TENS only seems to have marginal additional effects on OAB symptoms. Introduction

In recent decades, electrical stimulation has been widely used for the treatment of lower

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urinary tract dysfunction, both with the aim of inducing activity and reducing overactivity in the bladder. It has been successfully used for many years for treatment of urge incontinence in adults, with stimulation in the anogenital region [1]. A couple of studies using anal

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stimulation have also been performed in children, with good results in children with severe urge incontinence[2, 3].

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The problem when treating children with stimulation in the anogenital region,

however, is the invasiveness of the method. Therefore, reports that parasacrally applied transcutaneous electrical nerve stimulation (TENS) can be effective in the treatment of overactive bladder (OAB) made the method more attractive from a compliance perspective when treating children. Bower et al. [4] and Hoebeke et al. [5] were first to show, in uncontrolled studies, an effect of TENS in children with refractory OAB, and have been followed by others [6,7]. Recently, two randomized controlled trials (RCT) have been

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published confirming the effects of TENS on OAB symptoms [8,9]. One of the two controlled studies also included patients with non-refractory OAB. In this latter study it was shown that TENS was more effective in OAB children without prior treatment than with only standard urotherapy [9].

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The aim of the present study was to investigate whether addition of active TENS treatment improves the results of standard urotherapy in children with OAB symptoms. A possible advantage of TENS treatment in children with refractory OAB symptoms was also

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addressed. Patients and methods

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Sixty-two children, 35 boys and 27 girls, with symptoms of OAB and incontinence were included in the present study at a median age of 8 years (range 5.3–11.5 years). To be eligible for the study, typical symptoms of OAB had to be present, including urgency, frequent voiding, holding man oeuvres to avoid leakage at urgency, and daytime incontinence episodes

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(Table 1).

All eligible children and their parents were informed about the study in a telephone call before their first appointment, and written information was sent. For those who

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were interested in participating in the study the following were done at the first appointment: a structured voiding history was taken, flow/residual was performed as well as urinalysis and

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physical examination. If a child was on medication for lower urinary tract problems, it had to be terminated after the appointment. The study started with a run-in period of 2 weeks during which a 3-day voiding–drinking diary was kept: incontinence episodes were registered for 7 days and defecation measurements were made. After 2 weeks of observation and registration, children with voiding symptoms according to the inclusion criteria and without any of the exclusion criteria were included in the study (Table 1). Children with constipation problems had to be treated before inclusion in

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the study. The accepted children were then randomized either to urotherapy treatment alone or a combination of urotherapy and TENS. The randomization was computerized and done according to a minimization procedure, considering age, sex, previous treatment, number of voidings, and frequency of incontinence episodes in the two groups.

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Standard urotherapy, including behavioral therapy and detailed lifestyle advice in order to normalize bladder function, was given to both groups. Urotherapy included

motivation of the child to cooperate actively in the treatment process by explaining what

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normal body and lower urinary tract function means and what has to be changed. Examples of such factors in daily life affecting bladder function are voiding position, timed voiding and

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thus voiding before urgency attacks, drinking habits, quality of beverages and prevention of constipation [10,11].

The child and the parents were instructed in handling a stimulator at home. A single-channel stimulator (CEFAR PRIMO, Lund, Sweden) was used. CEFAR PRIMO is a

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constant-current stimulator, and is used to be certain that the same current would be delivered regardless of resistance. The frequency, the pulse per second, used during TENS treatment was a low frequency, 10 Hz, which according to previous reports should mainly activate

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inhibitory pathways to the detrusor [12]. Current intensity was increased to the maximal level tolerated by the child and reached a maximum of 40 mA. Self-adhesive surface electrodes

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applied bilaterally over the sacral region (S2–S3) were used for stimulation. The patients were instructed to apply the stimulation twice a day for 20 minutes

each time.

The treatment period in the study was 12 weeks. There were four scheduled visits during this period, including the visit at the end of study. At 6 weeks and at study end, investigation of the effects was performed by registration of a voiding–drinking diary.

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ACCEPTED MANUSCRIPT The effect variables were taken from the voiding-drinking diary: number of voiding, maximum voided volume, and number of incontinence episodes. Statistics Power calculations before the start of the study indicated that 60–70 patients were needed if

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the effect of standard urotherapy was 50% and addition of TENS 80%.

For the results, categorical and dichotomous variables were described using

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number and percentage and continuous variables using mean, SD, median, and range. For comparison of continuous variables between two groups the Mann–Whitney U-test was used,

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and for comparison of dichotomous variables between two groups Fisher’s exact test. Changes within groups were analyzed with the Wilcoxon signed rank test for continuous variables. All tests were two-tailed and conducted at the 5% significance level

Results

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Demographics

The intention to treat (ITT) population consisted of 62 randomized children (35 boys, 27 girls). Mean and median ages of the children were 8 years in both groups. Demographic and

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clinical characteristics (ITT population) were comparable in the two groups (Table 2), which was also true for frequency of earlier treatment (27% and 28%) and history of UTIs (13% and

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19%) (Table 2).

Seven out of the 62 patients, six boys and one girl, discontinued the study. The

per-protocol (PP) population thus consisted of 55 patients included in the analyses. The reasons for drop-out in the standard therapy group were disappointment because they were randomized to the group that did not receive TENS (2), and dry after the randomization visit (1). In the TENS group the reasons were non-compliance (2), adverse effects of the electrodes (1), and increased incontinence during treatment (1).

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ACCEPTED MANUSCRIPT Efficacy of treatment Standard treatment group The children in the standard treatment group had a significant reduction in the number of

voidings (–1.2 from 7.7 voiding/day). On an individual basis, two-thirds of the patients in the

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group (64%) had a decrease in the number of voidings, whereas the rest had an unchanged number. Decrease in incontinence episodes in the group was also significant (–1.5 from 2.2 episodes/day). Total continence was achieved by 13/28 subjects (46%) after treatment,

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improvement was seen in 11 (40%), and no change in four (14%) (Table 3). Using the ICCS recommended grouping for these continence results, full response was seen in 13/28 (46%),

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partial response in 8/28 (29%), and no response in 7/28 (25%). Maximal voided volume increased significantly during treatment (+20 mL from 144 mL) (Table 3). These objective figures corresponded to the subjective experience as described by the patients: 72% considered themselves as significantly improved or free from symptoms, whereas the

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remaining patients experienced little if any improvement. Standard treatment + TENS

In the group with addition of TENS to the standard treatment the results were similar, with

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significant improvement within the group, both regarding reduction in the number of voidings (63% of the patients, –1.3 from 7.3 voiding/day) and reduction in the number of incontinence

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episodes (80% of the patients, –1.5 from 1.9 episodes/day). The number of children who achieved total continence was 16/24 (67%), whereas three (13%) improved and five (20%) were unchanged, which was in accordance with full, partial, and no response, respectively, according to the ICCS recommendations. Contrary to expectation, no increase in maximal voided volume was seen, but instead a tendency to decrease (–20 mL from 158 mL). Subjective experience corresponded to objective: 80% considered themselves as significantly improved or free from symptoms.

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ACCEPTED MANUSCRIPT Comparison between standard treatment group and standard treatment +TENS group No difference between the groups was seen in terms of reduction in number of voidings or incontinence episodes (Fig. 1). There was a numerical, but not statistical, difference in the number of children who were completely dry after treatment: 13/28 (46%) in the standard

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group and 16/24 (67%) in the standard + TENS group (p = 0.303).

Influence of previous treatment on results in both standard and standard + TENS groups

Previous treatment was registered in seven (24%) and eight (27%) children in the two groups,

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respectively, in the PP population. Regarding the number of voidings per day, there was a decrease in the number of children with a registered reduction in the standard treatment group

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from 16/21 (76%) without previous treatment to 2/7 (29%) with previous treatment (p = 0.105); in the TENS group the difference was less pronounced (12/17 (71%) and 4/7 (57%), respectively, p = 0.652) (Table 4).

A similar numerical decrease in the number of children with a reduction in the

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number of incontinence episodes was also seen in those with previous treatment compared with children without such treatment. In the standard treatment group, the reduction went from 19/21 (91%) of the patients without previous treatment to 5/7 (72%) in those with

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previous treatment (p = 0.645); in the TENS group the reduction went from 15/17 (89%) to 4/7 (57%), respectively (p = 0.573) (Table 4). The number of children who were completely

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dry in the group with previous treatment was also reduced compared with the children without earlier treatment, in both the standard (48% to 43%) and in the TENS (71% to 57%) groups (Fig. 2). In children without previous treatment the number who were completely dry in the TENS group (71%) had a tendency to be higher than in children with standard urotherapy only (48%), (p = 0.05) (Fig. 2). Discussion

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ACCEPTED MANUSCRIPT In this randomized controlled trial (RCT) in children with OAB symptoms, treatment with standard urotherapy was shown to be equally effective as standard therapy with the addition of TENS. A full response was seen in almost half of the children in the standard group and in two-thirds of the children in the TENS group. The only difference was a higher proportion of

refractory incontinence, i.e. subjected to earlier treatment.

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children becoming completely dry in the TENS group, when excluding the children with

Two controlled trials of TENS treatment have been published recently. In both

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studies a superior effect of TENS has been reported than with standard urotherapy alone. However, the success rates were similar to those in the present study. In the study by Lordelo

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et al. [9], who included non-refractory patients, as we do in the present study, the subjective success rate, as indicated by the parents using a VAS scale, was 62%, which was similar to that seen in the TENS patients in our study (67% completely dry). Their results were significantly better than standard urotherapy/sham stimulation, whereas ours were not. The

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explanation was probably the superior treatment effect in our standard urotherapy group, with a complete response in 46%, compared with no cases with complete response in the Lordelo study. The level of success with standard therapy in children with OAB in the present study

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was probably comparable to other reports, even if studies dealing only with children with OAB and the effect of standard urotherapy are scarce [13]. However, from randomized

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studies testing anticholinergic drugs in children with OAB, the group without active treatment had a success rate of 47% in one study [14], and in another urotherapy before randomization, resulted in improvement of symptoms in almost 40% of the patients [15]. The second RCT included only children with refractory OAB, and urodynamics was also performed, confirming the presence of overactive contractions [8]. Active TENS in this study led to partial response (improvement 50–90%) in 61% of the children and to a significant decrease in wet days per week and incontinence scores (according to dry pie

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ACCEPTED MANUSCRIPT records) when comparing before and after treatment. Hagstroem et al. [8] did not notice such

an improvement in their sham group. In the present study about one-fourth of the children had had previous treatment, and were thus considered to have refractory OAB. Our results in the refractory OAB children were inferior to those in children with non-refractory OAB in both

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the standard urotherapy and the TENS groups, meaning that TENS treatment in our refractory patients did not seem superior to standard urotherapy. The lack of superior results for TENS treatment in our refractory patients may be explained by the low number of patients (15 of a

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total 55). What we found, on the other hand, was a better effect of TENS than urotherapy in those without previous treatment, i.e. the non-refractory patients.

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One problem with our study was, of course, that no sham stimulation was performed in the control group with only standard urotherapy. On the other hand, this would only be a problem in the case when TENS treatment was superior to standard treatment. Since this was not the case, we do not consider this to have influenced our results. Another

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drawback was the fact that urgency was only asked for but not measured before and after treatment in the groups, depending on the difficulty to get a reliable measure of the degree in small children [16]. However, the parents often reported improvement of urgency in parallel

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to decrease in incontinence episodes.

One interesting finding in our study was that standard treatment showed an

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increase in maximal voided volume during treatment, whereas in the TENS group such an increase in the bladder reservoir was not noted. A similar finding was reported in the study from Aarhus dealing with TENS treatment of children having refractory OAB symptoms [8]. This report and our observations are in contrast with previous studies dealing with the effect of neuromodulation, where bladder capacity was shown to increase in response to TENS treatment [4,5,9,17]. The Aarhus group speculated about the positive effect of TENS being a result of improved sensation of bladder signals, which in fact might be a possibility according

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ACCEPTED MANUSCRIPT to data presented by Braun et al .[18]. In the latter study, response in the sensory cortex was registered by EEG, induced by S3 stimulation using a low frequency (10–20 Hz), which is

interesting since such stimulation has been shown to mainly influence the motor response of the bladder. To influence sensory neurons, higher frequency should be needed (150 Hz)

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[12,19]. This means that the effect of TENS can probably be via more than one mechanism and might hypothetically explain why some patients benefits from the treatment and others not.

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In conclusion, our results showed no significant difference overall in treatment response to OAB symptoms between urotherapy only and TENS in combination with

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urotherapy, when including children with and without previous treatment. However, children with non-refractory OAB had a tendency to be completely dry more often in the group with addition of TENS. Overall with good urotherapy support, TENS seems only to have marginal additional effects on OAB symptoms. Therefore, TENS should not be used as first-line

earlier studies.

None. Funding

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Conflict of interest

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treatment in OAB children, but may be an option in refractory cases as has been suggested in

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This study was financially supported by grants from the Region Västra Götaland. Ethical approval

The study was approved by the Ethics Committee at the University of Gothenburg. References [1] Fandel T, Tanagho EA. Neuromodulation in voiding dysfunction: a historical overview of neurostimulation and its application. Urol Clin North Am 2005;32:1–10.

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[2] Gladh G, Mattsson S, Lindstrom S. Anogenital electrical stimulation as treatment of urge incontinence in children. BJU Int 2001;87:366–71. [3] Trsinar B, Kraij B. Maximal electrical stimulation in children with unstable bladder and nocturnal enuresis and/or daytime incontinence: a controlled study. Neurourol Urodyn

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1996;15:133–42.

[4] Bower WF, Moore KH, Adams RD. A pilot study of the home application of transcutaneous neuromodulation in children with urgency or urge incontinence. J Urol

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2001;166:2420–2.

[5] Hoebeke P, Van Laecke E, Everaert K, Renson C, De Paepe H, Raes A, et al.

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Transcutaneous neuromodulation for the urge syndrome in children: a pilot study. J Urol 2001;166:2416–9.

[6] Barroso U, Jr., Lordelo P, Lopes AA, Andrade J, Macedo A, Jr., Ortiz V. Nonpharmacological treatment of lower urinary tract dysfunction using biofeedback and

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transcutaneous electrical stimulation: a pilot study. BJU Int 2006;98:166–71. [7] Malm-Buatsi E, Nepple KG, Boyt MA, Austin JC, Cooper CS. Efficacy of transcutaneous electrical nerve stimulation in children with overactive bladder refractory to pharmacotherapy.

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Urology 2007;70:980–3.

[8] Hagstroem S, Mahler B, Madsen B, Djurhuus JC, Rittig S. Transcutaneous electrical nerve

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stimulation for refractory daytime urinary urge incontinence. J Urol 2009;182:2072–8. [9] Lordelo P, Teles A, Veiga ML, Correia LC, Barroso U, Jr. Transcutaneous electrical nerve stimulation in children with overactive bladder: a randomized clinical trial. J Urol 2010;184:683–9. [10] Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, et al. The standardization of terminology of lower urinary tract function in children and adolescents:

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report from the Standardisation Committee of the International Children’s Continence Society. J Urol 2006;176:314–24. [11] Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, et al. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology 2006;130:1527–37.

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[12] Lindstrom S, Fall M, Carlsson CA, Erlandson BE. The neurophysiological basis of bladder inhibition in response to intravaginal electrical stimulation. J Urol 1983;129:405–10. [13] Hoebeke P. Twenty years of urotherapy in children: what have we learned? Eur Urol

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2006;49:426–8.

[14] Nijman RJ, Borgstein NG, Ellsworth P, Djurhuus JC. Tolterodine treatment for children

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with symptoms of urinary urge incontinence suggestive of detrusor overactivity: results from 2 randomized, placebo controlled trials. J Urol 2005;173:1334–9.

[15] Marschall-Kehrel D, Feustel C, Persson de Geeter C, Stehr M, Radmayr C, Sillen U, et al. Treatment with propiverine in children suffering from nonneurogenic overactive bladder

Eur Urol 2009;55:729–36.

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and urinary incontinence: results of a randomized placebo-controlled phase 3 clinical trial.

[16] Bower WF, Moore KH, Adams RD. A novel clinical evaluation of childhood

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incontinence and urinary urgency. J Urol 2001;166:2411–5. [17] Bosch JL. Electrical neuromodulatory therapy in female voiding dysfunction. BJU Int

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2006;98 Suppl 1:43–8; discussion 9. [18] Braun PM, Baezner H, Seif C, Boehler G, Bross S, Eschenfelder CC, et al. Alterations of cortical electrical activity in patients with sacral neuromodulator. Eur Urol 2002;41:562–6; discussion 6–7. [19] Bower WF, Moore KH, Adams RD, Shepherd R. A urodynamic study of surface neuromodulation versus sham in detrusor instability and sensory urgency. J Urol 1998;160:2133–6.

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ACCEPTED MANUSCRIPT AQ1: please check the author affiliations AQ2: ‘Power calculations before the start of the study indicated that 60–70 patients

were needed if the effect of standard urotherapy was 50% and addition of TENS 80%.’ Please check the sentence for sense

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AQ3: when writing reductions rather than presenting as, for example, (-1.2 from 7.7 voiding/day) can they be presented as (from 7.7 to 6.5 voiding/day)?

AQ4: Table 1: please check the text after ‘High bladder capacity’: are the symbols

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correct or has there been some corruption?

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AQ5: please check that the figure have been cited correctly

Figure 1

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ACCEPTED MANUSCRIPT

Fig 1

0.7 0 -0.7 -1.4

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-2.1

Median

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1.4

Mean

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Decrease in incontinence episode (n/day)

-2.8

-3.5

-4.2

-4.9

Mean: -1.46

-1.50

p=1.00

-5.6 -6.3

Standard Treatment

TENS+standard Treatment

Figure 2

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ACCEPTED MANUSCRIPT

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Fig 2

Completly 100 dry (%)

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p=0.05

No previous treatment

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80 60

Previous treatment

40 20

0 Standard treatment

TENS + standard treatment

Figure Legends

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Legends Figure 1. Decrease in number of incontinence episodes in 55 children with OAB. Comparison between group treated with standard urotherapy only and group with addition of TENS

Table 1. Inclusion and main exclusion criteria

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Table 2. Baseline demographic data (ITT population)

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Figure 2. Number of children with OAB that were completely dry after treatment in relation to previous treatment. Comparison between group treated with standard urotherapy only and group with addition of TENS.

according to treatment group

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Table 3. Difference in efficacy variables (PP population) from baseline to end of treatment

Table 4. Difference in efficacy variables from baseline to end of treatment according to

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treatment group and previous treatment

edited figure and table Legends

ACCEPTED MANUSCRIPT Figure 1 Decrease in number of incontinence episodes in 55 children with overactive bladder. Comparison between group treated with standard urotherapy only and group with addition of TENS. Figure 2 Number of children with overactive bladder, completely dry after treatment, in

only and group with addition of TENS. Table 1 Inclusion and main exclusion criteria.

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relation to previous treatment Comparison between group treated with standard urotherapy

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Table 2 Baseline demographic data (intention to treat population).

treatment according to treatment group.

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Table 3 Difference in efficacy variables (per-protocol population) from baseline to end of

Table 4 Difference in efficacy variables from baseline to end of treatment according to

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treatment group and previous treatment.

Table 1

ACCEPTED MANUSCRIPT Table 1 Children 5-12 years

Inclusion criteria

Micturition frequency ≥7* Incontinence episodes≥1 within 7 days

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Urgency High bladder capacity (>150% of ⌠(age+1)x30⌡ml)

Exclusion criteria

Postvoid residual >10 ml

Dysfunctional voiding (according to flow curve)

Untreated UTI

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Concomitant drug treatment of OAB symptoms

Untreated constipation

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*At start of study 15 children with ≥5 voiding/day were included, similar number in the two groups.

Table 2

ACCEPTED MANUSCRIPT Table 2 Standard treatment Standard + TENS

p-value

(n=32)

(n=30)

- Boys - girls Age (yr)

16 (50%) 16 (50%) 8 (1.5)

19 (63%) 11 (37%) 8 (1.9)

0.506 0.891

Weight (kg)

30 (8.0)

30 (9.4)

0.923

Height (cm)

131 (11.6)

130 (13.5)

0.811

Previous treatment, total -Standard UT -UT+anticholinergics UTI

9 (28%) 5 4 6 (19%)

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Characteristic

8 (27%) 3 5 4 (13%)

0.888 0.873

Voiding frequency/day

7.7 (1.9)

7.3 (2.2)

0.524

Incontinence episodes/day

2.2 (1.5)

1.9 (1.5)

0.534

Maximal voided volume ml

144 (59)

158 (69)

0.435

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Sex

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For categorical variables n (%) and for continuous variables mean (standard deviation) are presented

Table 3

ACCEPTED MANUSCRIPT Table 3 Efficacy variables

Standard treatment n=29

Standard + TENS n=26

p-value within group

-1.3 (2.0)

0.002

0.951

-1.5 (1.4)

Effects of transcutaneous neuromodulation (TENS) on overactive bladder symptoms in children: a randomized controlled trial.

The aim of the present study was to investigate whether addition of transcutaneous electrical nerve stimulation (TENS) treatment improves the results ...
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