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Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia

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Abstract

Purpose

The Butterfly Prostatic Retraction Device (“Butterfly”) is a permanent nitinol implant for benign prostatic hyperplasia. This study examines the chronic response of prostate tissue to the Butterfly in histological specimens from patients in the Butterfly pilot clinical study.

Methods

Retrospective qualitative and semi-quantitative review of histological specimens of seven (7) patients who participated in the Butterfly pilot clinical study. Patients had at least 1-month implantation with the Butterfly prior to implant removal and TURP. Tissue samples were graded by two pathologists.

Results

Four out of six patients had IPSS decreased from baseline. All seven patients’ samples had signs of chronic inflammation; one demonstrated acute inflammation and one demonstrated fibrosis. In three cases, intraglandular calcification was identified. There was no ischemic necrosis induced by the implant, and no encrustation, urethral edema, or cellular atypia was noted.

Conclusion

The Butterfly demonstrated an overall favorable safety profile in terms of tissue response. This study demonstrates that there is no significant tissue reaction in the prostatic urethra due to presence of Butterfly device.

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Data, material, and/or code availability

All relevant raw data are stored in a password protected drive. It is freely available to any scientist wishing to use them for non-commercial purposes. This data can be provided with request.

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Acknowledgements

We would like to thank Patho-Logica Ltd, Israel for supporting the initial analysis of the tissue specimen and Prof Rumelia Koren for help with providing images of the pathology and official pathology report.

Funding

No funding was received for conducting this study.

Author information

Author notes

  1. Ran Katz and Christina Sze contributed equally to this work.

Authors and Affiliations

  1. Ziv Medical Center, Safed, Israel

    Ran Katz, Muhamad Abu Ahmed & Ali Safadi

  2. Department of Urology, Weill Cornell Medicine/New York-Presbyterian Hospital, 525 E. 68Th Street, New York, NY, 10021, USA

    Christina Sze, Ananth Punyala & Bilal Chughtai

  3. Shamir Medical Center, Zrifin, Israel

    Shmuel Roizman & Amnon Zisman

  4. Rabin Medical Center, Petach Tikva, Israel

    Shachar Aharoni & Jack Baniel

Authors
  1. Ran Katz
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  2. Christina Sze
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  3. Ananth Punyala
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  4. Muhamad Abu Ahmed
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  5. Ali Safadi
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  6. Shmuel Roizman
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  7. Amnon Zisman
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  8. Shachar Aharoni
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  9. Jack Baniel
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  10. Bilal Chughtai
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Contributions

RK: protocol/project development, data analysis, manuscript writing/editing; CS: data analysis, manuscript writing/editing; AP: data analysis, manuscript writing/editing; MAA: data collection or management, critical revision of manuscript; AS: data collection or management, critical revision of manuscript; SR: data collection or management, critical revision of manuscript; AZ: data collection or management, critical revision of manuscript; SA: data collection or management, critical revision of manuscript; JB: data collection or management, critical revision of manuscript; BC: protocol/project development, data collection or management, critical revision of manuscript, supervision.

Corresponding author

Correspondence to Bilal Chughtai.

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Conflict of interest

BC is a consultant for Boston Scientific and Olympus.

Ethical approval

The procedures used in this study adhere to the tenets of the Declaration of Helsinki. This study is a retrospective review of histological data of patients participating in the Butterfly pilot clinical study (NCT03912558), first posted on April 15, 2022 (ClinicalTrials.gov).

Consent to participate and publish

Informed consent was obtained from all individual participants included in the study.

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Katz, R., Sze, C., Punyala, A. et al. Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia. World J Urol 41, 1141–1146 (2023). https://doi.org/10.1007/s00345-023-04319-w

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  • DOI: https://doi.org/10.1007/s00345-023-04319-w

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