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Surgical Treatment for Benign Prostatic Hyperplasia: Holmium Laser Enucleation of the Prostate HoLEP.
Published on: March 6, 2018
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Histotripsy Treatment of Benign Prostatic Enlargement Using the Vortx Rx System: Initial Human Safety and Efficacy
Timothy G Schuster1, John T Wei2, Kari Hendlin3
1Department of Urology, ProMedica, Toledo, OH.
Urology
|January 14, 2018
Summary
Histotripsy treatment for benign prostatic enlargement demonstrated safety in a pilot study. While not reducing prostate size, it significantly improved lower urinary tract symptoms in men.
Area of Science:
- Urology
- Medical Devices
- Acoustic Medicine
Background:
- Benign prostatic enlargement (BPE) causes lower urinary tract symptoms (LUTS) in men.
- Current treatments for BPE have limitations and potential side effects.
- Histotripsy offers a novel, non-invasive approach using focused ultrasound.
Purpose of the Study:
- To evaluate the clinical safety and efficacy of histotripsy for treating symptomatic BPE.
- To assess the feasibility of the Vortx Rx system in a first-in-human study.
- To determine the impact of histotripsy on LUTS and prostate tissue.
Main Methods:
- A prospective, single-arm study enrolled 25 men with moderate to severe LUTS and BPE.
- Histotripsy treatment was delivered via the perineum under real-time ultrasound guidance.
- Follow-up included assessments at 1 day and 1, 3, and 6 months post-procedure.
Main Results:
- Histotripsy was safe, with no serious intraoperative adverse events; device-related events included transient urinary retention and anal abrasion.
- No significant reduction in prostate size or improvement in uroflow/postvoid residual urine was observed.
- Significant improvement in International Prostate Symptom Score was noted at 1, 3, and 6 months (P < .001).
Conclusions:
- Prostate histotripsy is a safe and well-tolerated treatment for symptomatic BPE in this initial human trial.
- The procedure led to significant symptom improvement despite a lack of observed tissue debulking.
- Histotripsy shows promise for managing LUTS associated with BPE.
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