Presented by: Carlos A. Garcia Becerra MD
UROVALLARTA Urology Center

Introduction

Benign Prostatic Hyperplasia (BPH) is a disease that affects one-third of men older than 50 years and is histologically evident in up to 90% at 85 years. Men with this pathology suffer from Lower Urinary Tract Symptoms (LUTS) in approximately 50% of men in the sixth decade of life and 80% in the ninth decade. 

In this epidemiological context, this protocol aims to evaluate the efficacy and safety of a new Focused Ultrasound Surgery (FUS) modality named Histoblast and evaluate as a new minimally invasive therapy for BPH.

Materials

A prospective clinical study was conducted, with nine patients enrolled until now. The traditional tissue ablation function of the FUS device was modified by changing the treatment plan, energy delivery and implementation of prostate compression.

At treatment, the cavitation phenomena was verified with the FUS Device. Qmax assessment, IPSS, and IIEF-5 questionnaires were conducted pre- and post-treatment, with a follow-up of 2 months. Magnetic resonance Image (MRI), ultrasound and histopathological analyses were conducted at post-treatment time.

A Kruskal-Wallis ANOVA test and a Mann-Whitney t-Student test were conducted for the statistical analysis.

Results

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During treatment, a significant increase of the amount of cavitation phenomena was registered in every treatment with >80%, with less dissipation of ultrasound energy due to tissue compression.

The IPSS and Quality of Life results demonstrated a significant improvement in the scoring, throughout the 2-month follow-up. The IIEF-5 score shows no significant change among the patients, due to treatment. The Qmax assessment showed a significant improvement. The MRI and ultrasound scans showed precise ablation to the BPH area, with preservation of the urethra and peripheral zone. The histologic analysis demonstrated complete destruction of the tissue architecture in the treated area.

Conclusion

The image guidance during the treatments, confirmed, that this new FUS treatment modality increases the boiling cavitation ablative phenomena, instead of the thermo ablation produced by the original protocols. Keeping the same safety parameters approved in several countries, for prostate ablation. The preliminary results confirmed the efficacy of BPH ablation, with good clinical improvement. We concluded that Histoblast is a very safe, precise, and repetitive treatment, positioning it as a promising alternative in the Minimally Invasive Surgical Treatments for BPH.

Funding

UROVALLARTA Urology Center

Lead Authors

Carlos M. García Gutierrez, MD
UROVALLARTA Urology Center

Naren Sanghvi, PHD
Sonablate Co.

Natalia Garcia Becerra, PHD
UROVALLARTA Urology Center

Sunao Shoji, MD, PHD
Tokai University School of Medicine, Department of Urology

Leonardo Fernandez Avila, PHD
CIBO IMSS

Habid Becerra Herrejon, MD
UROVALLARTA Urology Center