Author's Accepted Manuscript Does Extracorporeal Shock Wave Lithotripsy Cause Hearing Impairment In Children? Murat Tuncer, Cahit Sahin, Ozgur Yazici, Alper Kafkasli, Akif Turk, Banu A. Erdogan, Gokhan Faydaci, Kemal Sarica

PII: DOI: Reference:

S0022-5347(14)04622-9 10.1016/j.juro.2014.09.118 JURO 11878

To appear in: The Journal of Urology Accepted Date: 26 September 2014 Please cite this article as: Tuncer M, Sahin C, Yazici O, Kafkasli A, Turk A, Erdogan BA, Faydaci G, Sarica K, Does Extracorporeal Shock Wave Lithotripsy Cause Hearing Impairment In Children?, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.09.118. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed 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.

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Does Extracorporeal Shock Wave Lithotripsy Cause Hearing Impairment In Children?

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Murat Tuncer1, Cahit Sahin2, Ozgur Yazici3, Alper Kafkasli4, Akif Turk5, Banu A. Erdogan6, Gokhan Faydaci7, Kemal Sarica8.

1. M.D., Dr. Lutfi Kirdar Training and Research Hospital Urology Clinic, Istanbul,

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Turkey.

2. M.D., Dr. Lutfi Kirdar Training and Research Hospital Urology Clinic, Istanbul, Turkey.

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3. M.D., Dr. Lutfi Kirdar Training and Research Hospital Urology Clinic, Istanbul, Turkey.

4. M.D., Dr. Lutfi Kirdar Training and Research Hospital Urology Clinic, Istanbul, Turkey.

5. M.D., Akhehir Goverment Hospital Urology Clinic, Konya, Turkey.

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6. M.D., Dr. Lutfi Kirdar Training and Research Hospital Otorhinolaryngology Clinic, Istanbul, Turkey.

7. Assistant professor, Lutfi Kirdar Training and Research Hospital Urology Clinic, Istanbul, Turkey.

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8. Professor, Lutfi Kirdar Training and Research Hospital Urology Clinic, Istanbul, Turkey.

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Runninghead: Does SWL Cause Hearing Impairment In Children? Key words: SWL (Extracorporeal Shockwave Lithotripsy), Urinary stones, Children; TEOAE (Transient Evoked Otoacoustic Emissions). Hearing Impairment.

ACCEPTED MANUSCRIPT Abstract: Purpose: To evaluate the possible effects of noise created by High Energy Shock Waves (HESW) on the hearing function of children treated with Extracorporeal Shockwave Lithotripsy (SWL).

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Materials and Methods: A total of 65 children with normal hearing function was included to the study who were then divided into three groups; children becoming stone free after one session (Group 1, n= 22), children requiring three sessions for stone free status (Group 2, n=

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21) and healthy children as a control group (Group 3, n= 22). SWL procedure was applied at supine position with a 90\min frequency and a total of 2000 shock wave in each session

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(Dornier Compact Sigma, Medtech, Germany). Second energy level was used with a maximum energy value of 58 joule/session in all patients. The hearing function and possible cochlear impairment have been evaluated by Transient Evoked Otoacoustic Emissions (TEOAE) test at 1.0, 1.4, 2.0, 2.8, 4.0 kHz frequencies prior to the procedure, two hours and

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one month after the completion of SWL in both study group patients. The same evaluation procedures were performed prior to the study and 7 weeks after in the control group. Results: Regarding TEOAE data obtained in study group and control group patients, there

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was no significant alteration in values obtained after SWL when compared with the values prior to the procedure.

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Conclusions: A well planned SWL procedure is a safe and effective treatment in urinary stones and causes no detectable harmful effect on the hearing function of the treated pediatric patients.

ACCEPTED MANUSCRIPT Introduction:

Following its clinical introduction in early 1980’s,Extracorporeal Shock Wave Lithotripsy (SWL) has become the most popular therapy for urinary calculi throughout the

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world with its effective and safe results in the majority of upper urinary stones both in adults and children1. First successful SWL data in children has been reported by Newman et al. in 19862. Although SWL has not yet been approved by U.S. Food and Drug Administration

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(FDA) in pediatric patients, there are many studies showing the effectiveness and safety of SWL in children.3-7

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Despite the accumulated evidence indicating its highly successful and safe nature of SWL in children, some complications; however, have been reported in the literature among which hematuria, small subcapsular hematoma, petechiae on the skin, urinary tract infection, fever, renal colic and steinstrasse are the most commonly encountered problems.7,8

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In addition to these well-known risks another potential risk could originate from the noise produced by the high energy shock waves (HESW) with possible negative effects on the hearing function of treated cases.

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Noise induced hearing loss is caused by repeated exposure to loud sounds over an extended period of time, exposure to very loud impulse sound(s), or a combination of both.

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Exposure to continuous high intensity noise initiates a cascade of reactions at a cochlear level, leading to death by apoptosis of the outer hair cell of the organ of Corti organ.9 TEOAE is a diagnostic method widely used during the past decade to study cochlear function, in a noninvasive and objective manner. Otoacoustic emission measurements are a sensitive indicator in assessing peripheral hearing functions. It allows us to objectively monitor small changes in the cochlea and determine the cochlea component that is causing hearing loss

ACCEPTED MANUSCRIPT which cannot be determined using other audiology methods.

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Because of this, we prefer

TEOAE to detect cochlear function. Although some contradictory data have been reported in the literature focusing on the possible effects of HESW induced noise on the hearing status of adult cases10,12-16 to our

HESW on hearing function of children undergoing SWL.

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knowledge, no study so far in the literature aimed to evaluate the possible adverse effects of

In this present prospective controlled study, we aimed to evaluate the possible effects

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of noise created by HESW on the hearing function of children treated with SWL.

ACCEPTED MANUSCRIPT Materials and Methods:

43 pediatric patients with solitary renal stones referring to urology department between December 2012 and March 2014 were included into this prospective controlled study

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program. Study protocol was approved by Dr. Lutfi Kirdar Kartal Training and Research Hospital’s Etic Committee (Date: 13.11.2012, file number: 11). All the steps of the study were planned and applied carefully according to Helsinki Declaration.

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The patients with previous SWL history, hearing loss, tinnitus and previous ear surgery were all excluded from the study program. A total of 65 children (including the children becoming stone free (SF) after one

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control cases) were divided into three groups:

session (Group 1, n= 22), children requiring three session for SF status (Group 2, n= 21) and as control group children referred to the healthy child outpatient department (Group 3, n= 22). Prior to SWL, in addition to routine biochemical tests, urinalysis, urine culture sensitivity test, bleeding and clotting times and ECG; radiologic evaluation with kidney-

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ureter- bladder (KUB) and/or urinary system ultrasonography was performed in the majority of the cases. A non-contrast abdominopelvic CT was applied when needed. Finally, all cases

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were again examined well at the otorhinolaryngology department for the actual status of hearing by otorhinolaryngologic examinations and TEOAE test.

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SWL procedure was applied using electromagnetic shock wave generating system (Dornier Compact Sigma, Medtech, Germany). General anesthesia was required for children and sedoanalgesia was used for younger children (Ketalar 0, 5-1 mg/kg and Dormicum 0, 050, 1 mg/kg). Opaque stones were localized by fluoroscopy whereas lucent stones were localized by ultrasonography. SWL procedure was applied at supine position with a 90\min frequency and a total of 2000 SW (shock wave) in each session. Second energy level was reached in first 200 SW with a maximum energy value 58 joule/session in all patients. All patients were evaluated one week after the first session of SWL with kidney-ureter- bladder

ACCEPTED MANUSCRIPT (KUB) and/or urinary system ultrasonography to define the stone fragmentation and obstruction (hydronephrosis) level. A maximum number of 3 SWL sessions was performed in all patients in the study group with one week period among each session. Concerning the evaluation of the hearing system, TEOAE values were recorded in all

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cases. The frequencies were tested at 1.0, 1.4, 2.0, 2.8, 4.0 kHz using Echoport OAE EZScreen 2. (Otodynamics ltd. 30- 38, Beaconsfield Road Hatfield Herts AL10 8BB, United Kingdom). A TEOAE response was considered positive and acceptable for analysis if it

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fulfilled all of the following criteria: 1) mean amplitude of the cochlear response being greater than the noise in the external canal; 2) reproducibility rate of the responses being greater than

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50%; 3) rate of stimulus stability being greater than 75%; 4) stimulus amplitude being 75 dB(decibels) SPL; 5) overall signal-to-noise of response (SNR) being 3 dB SPL; 6) rate of SNR at frequencies 1, 1.4, 2, 2.8, and 4 kHz being 3 dB SPL for at least two frequencies.17 All patients included into the study program had normal TEOAE responses, indicating normal

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hearing. All SNR data obtained were comparatively evaluated before and after treatment in all groups.

The sound produced by the lithotripter was recorded at lithotriptor’s SW generator head,

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the patient's ear and the operators (urologist) station levels by using Sound Level Meter. (Mini, A Type - ST-85A).

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In the study group cases, TEOAE test was applied first before the SWL procedure and then after two hours (short term) as well as one month (long-term) after the completion of the final session. In the control group cases; however, TEOAE test was applied first before SWL and 7 weeks after following the first session of SWL in accordance with the timing in study Group-2 cases (1 month after last session). Also, cooperative children were asked about the presence of tinnitus and/or hearing loss after the procedure.

ACCEPTED MANUSCRIPT All data was given as mean ± standard deviation and evaluated with Mann Whitney-U test, Kruskal-Wallis test, Wilcoxon signed ranks test. Statistical analysis was performed using

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SPSS v20.0 for windows. p 0 05), three was a significant difference between group-1 and group-2 with respect

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to the stone size (p

Does extracorporeal shock wave lithotripsy cause hearing impairment in children?

We evaluated the possible effects of noise created by high energy shock waves on the hearing function of children treated with extracorporeal shock wa...
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