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Comparative evaluation of tissue damage induced by ultrasound and impact dual-mode endoscopic lithotripsy versus conventional single-mode ultrasound lithotripsy

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Abstract

Objective

The aim of our study was to perform comparative investigation of the tissue safety of three different endoscopic lithotripter devices including a new single-probe/dual-energy lithotripter in an in vivo animal model. The Swiss LithoClast Trilogy was compared to the Storz Calcuson and the Swiss LithoClast Vario. The safety test simulated the accidental direct contact between lithotripter probes and the urothelium, which can occur when sliding off a stone or drilling through a calculus during lithotripsy. The safety test included a smallest (1.5 mm) and largest (3.3/3.4 mm) probe diameter per device.

Methods

Testing was performed in nine pigs (three animals per device). The bladder tissue was exposed to direct lithotripter probe contact at maximum power for 10 s to produce visible tissue lesions. Acute tissue trauma was evaluated using a simplified scoring model describing the expected bladder wall injuries for histological examination. After 7 days, all animals were killed, necropsied and examined post mortem. For between-group comparisons regarding microscopic histopathologic features, a Chi-square test was used. A p value < 0.05 was considered to be statistically significant.

Results

Irrespective of the lithotripter used, no systemic signs of toxicity were observed. Histologically, signs of normal ongoing healing were observed on the bladder mucosa. There were no significant differences in histological findings taking changes of the epithelium (p = 0.360), the leucocyte infiltration (p = 0.123), the vascular congestion (p = 0.929) and the edema (p = 1.0) between the groups into account.

Conclusions

The results of this study demonstrated a comparable safety between all lithotripsy devices.

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Funding

EMS Switzerland supplied the lithotripsy test equipment as well as all needed endoscopic facilities to study site. The company provided funding to acquire the test animals including animal housing during the study duration and the clinical research organization (CRO) to prepare the GLP compliant study protocol, study outcome analysis and study report including tissue histology.

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Author notes

  1. Wael Khoder and Frank Strittmatter have contributed equally.

Authors and Affiliations

  1. Department of Urology, University Hospital Freiburg, Freiburg, Germany

    Wael Khoder

  2. Department of Urology, University Hospital of Munich Campus Großhadern, Munich, Germany

    Frank Strittmatter, Abdulmajeed Alghamdi, Michael Seitz, Christian Stief & Markus Juergen Bader

  3. UroClinic München, Residenzstraße 18, Munich, Germany

    Michael Seitz & Markus Juergen Bader

Authors
  1. Wael Khoder
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  2. Frank Strittmatter
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  3. Abdulmajeed Alghamdi
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  4. Michael Seitz
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  5. Christian Stief
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  6. Markus Juergen Bader
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Contributions

WK: project development, data collection, data analysis, manuscript writing/editing. FS: project development, data collection, data analysis, manuscript writing/editing. AA: data analysis, manuscript editing. MS: manuscript editing. CS: manuscript. MJB: project development, data collection, data analysis, manuscript writing/editing.

Corresponding author

Correspondence to Markus Juergen Bader.

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Conflict of interest

All authors disclose any commercial association that might pose a conflict in connection with current submitted article.

Research involving animals

The study was approved and consented by the local ethic committee (Study no.: 126604B).

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Khoder, W., Strittmatter, F., Alghamdi, A. et al. Comparative evaluation of tissue damage induced by ultrasound and impact dual-mode endoscopic lithotripsy versus conventional single-mode ultrasound lithotripsy. World J Urol 38, 1051–1058 (2020). https://doi.org/10.1007/s00345-019-02747-1

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  • DOI: https://doi.org/10.1007/s00345-019-02747-1

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