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Histotripsy Treatment of Benign Prostatic Enlargement Using the Vortx R x System: Initial Human Safety and Efficacy Outcomes
Histotripsy Treatment of Benign Prostatic Enlargement Using the Vortx R x System: Initial Human Safety and Efficacy Outcomes
- Source :
- Urology. 114:184-187
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
Abstract
- Objective To assess clinical safety (primary) and efficacy (secondary) of histotripsy for treatment of symptomatic benign prostatic enlargement in a first-in human study. Methods Twenty-five male subjects with moderate to severe lower urinary tract symptoms, prostate size between 30 and 80 g, and no evidence of prostate cancer were enrolled at 2 sites in a prospective, single-arm study. Treatment consisted of acoustic energy delivery through the perineum with integrated real-time transrectal ultrasound monitoring using the Vortx Rx system. Follow-up evaluations were performed on postoperative day 1 and 1, 3, and 6 months. Results Twenty-five men underwent histotripsy treatment with no serious intraoperative adverse events. Postoperatively, 3 cases of transient urinary retention ( Conclusion Prostate histotripsy was safe and well tolerated in this pilot human trial with improvement in lower urinary tract symptoms.
- Subjects :
- medicine.medical_specialty
Urinary retention
business.industry
Urology
030232 urology & nephrology
medicine.disease
030218 nuclear medicine & medical imaging
Perineum
03 medical and health sciences
Prostate cancer
Histotripsy
0302 clinical medicine
medicine.anatomical_structure
Lower urinary tract symptoms
Prostate
Severity of illness
medicine
medicine.symptom
Adverse effect
business
Subjects
Details
- ISSN :
- 00904295
- Volume :
- 114
- Database :
- OpenAIRE
- Journal :
- Urology
- Accession number :
- edsair.doi...........b8382bc39a30dad7fa5acdb76e3811dc
- Full Text :
- https://doi.org/10.1016/j.urology.2017.12.033