Transrectal High-Intensity Focused Ultrasound Safe, Effective for BPH

April 29, 2003 (Chicago) — Transrectal high-intensity focused ultrasound (HIFU) therapy appears to be safe and effective for treating benign prostatic hyperplasia (BPH), according to a new study presented here at the annual meeting of the American Urological Association.

Allen D. Seftel, MD, from the Department of Urology at Case Western Reserve University in Cleveland, Ohio, and colleagues conducted a phase III study of 68 BPH patients aged 50 to 80 years at five centers. They evaluated the Sonablate HIFU device.

Normal rectal wall temperature was maintained throughout the 38-minute procedure via an additional rectal cooling balloon within the HIFU probe. To enhance the effect of ultrasound beam on the targeted tissue, a urethral Foley catheter was inserted into the bladder to aid in positioning and was kept in-situ during the treatment. Procedures were performed under either general anesthesia or intravenous sedation, neither of which had an obvious effect on outcome.

Patients returned home within a few hours after the procedure and the catheter was removed after four to five days.

One year after treatment, a 34% improvement in Qmax score (8.7 mL/sec to 11.7 mL/sec) and a 63% improvement in AUA Symptom Score (23.06 to 10.83) were observed. Furthermore, cystoscopic examination revealed significant prostate tissue changes after treatment, with 80% of patients showing cavity formation at the treatment site in the bladder neck and prostate.

All of the patients were treated safely without significant pain, blood loss, or complications, Dr. Seftel and colleagues report. Minor complications included hematospermia in 28% of patients and hematuria in 23% of patients. Transient retention, transient incontinence, and urinary tract infection were also observed in 10% or fewer patients. Long-term dysuria and impotence were not observed.

"We believe this therapy may be comparable to the gold standard transurethral resection of the prostate [TURP]," said Dr. Seftel.

According to Dr. Seftel, the results are also quite durable. "The procedure has now been demonstrated to remain effective for about five years," he told Medscape. "Anecdotally, we've noted some improvement in erectile function, and there's been no evidence of incontinence or rectal injuries," he added.

Dr. Seftel noted that patients may be more likely to have irritative symptoms with HIFU compared with TURP, as well as more frequency and perhaps some blood in the urine for a few days. "But the side effects are limited and overall the results compare favorably," he said.

Claus Roehrborn, MD, professor and chairman of the Department of Urology at the University of Texas Southwestern Medical Center in Dallas, noted that minimally invasive methods such as this one show promise, but the gold standard TURP is known to improve symptoms in 95% or more of patients.

"This study does not compare individual patients with themselves at baseline," he continued. "Rather it evaluates the average of the symptom scores, and this may mean that 20% to 30% of patients don't improve upon their own symptom scores  a much lower success rate than that of TURP."

The study was funded by Focus Surgery, Inc., Indianapolis, Indiana, the manufacturers of the HIFU device.

AUA 98th Annual Meeting: Abstract 1453. Presented April 29, 2003.

Reviewed by Gary D. Vogin, MD