Clinical Experience in BPH

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Bihrle et al. reported their initial human experience using HIFU for BPH in 1994 (23). This initial experience used a 4-MHz transducer. The power cycle was 25 watts for 4 s followed by a 12-s interval to allow heat dissipation (Sonoblate, Focal Surgery, M. Ipitas, CA). The group studied 15 patients with BPH patients who were selected based on symptom scores (AUA > 12), peak urinary flow rate (Qmax < 2 mL/s), voided volume (>125 mL), postvoid residual volume (<300 mL), prostate volume measured by ultrasound (<80 mL), and an anteroposterior diameter > 26mm. In addition to prostate therapy, the first ten patients underwent invasive transperineal thermometry for safety monitoring. Therapy was directed at the transition zone between the bladder neck and the veru-montanum and was computer controlled to allow treatment of multiple sectors. Safety assessment included proctoscopy immediately after treatment, cystoscopy, and renal ultrasound 3 mo after treatment.

The series is too small and too short to make conclusions regarding efficacy but serves as an excellent initial trial to provide insight into possible clinical efficacy and safety information. The mean symptom score decreased from 31.2 to 15.8 at 90 d. All but two patients had a reduction in baseline symptom score by 3 mo. Average urinary flow rates improved by 51% at 3 mo. All but two patients showed improvement in flow rates. Postvoid residual volumes did not change significantly (mean 154 mL to 123 mL at 3 mo).

The most frequent complication was urinary retention, which occurred in 11 of15 patients. The high rate of transient urinary retention was likely related to invasive thermometry; 9 of the first 10 patients undergoing thermometry experienced retention, whereas only 2 of 5

who did not have thermometry required catheterization. There were minor and transient effects such as hematuria and hematospermia, but minimal irritative symptoms were noted. No erectile dysfunction, transfusions, incontinence, or changes in sexual function were noted. Injury to the rectum or periprostatic tissue did not occur with the exception of insignificant subtrigonal extension in one patient seen on cystoscopy.

This initial experience showed promising clinical efficacy as measured by standard outcome parameters used in BPH clinical trials. More importantly, the thermometry and safety assessment confirmed the ability to use focused ultrasound technology to specifically target the transition zone without injury to the periprostatic structures. The authors suggested that optimal treatment parameters and monitoring techniques were likely to improve as more experience was gained.

Madersbacher et al. also reported their experience with HIFU in 1994, with an updated report in 1997 and again in 2000 (24-26). The 1994 report included phase I and phase II clinical trials. The phase I trial consisted of HIFU treatment in 22 patients before surgical removal for other disease (suprapubic prostatectomy, 4; radical prostatectomy, 12; cystoprostatectomy, 6) at various intervals after HIFU treatment (30 min to 10 d). Whole mount sections were used to assess histologic changes. Well-demarcated coagulative necrosis was identified. Accurate targeting was also confirmed, as the posterior prostate capsule remained intact and proctoscopy immediately posttreatment was unremarkable. The phase II trial was updated in 1997 after 54 prostates were assessed. The conclusions were similar to those of the earlier report.

The initial clinical data presented in 1994 included 50 men with symptomatic BPH (24). The inclusion criteria were Qmax <15 mL/s, AUA symptom score >18, prostate volume <75 mL, PSA < 10.0 ng/mL, and sterile urine. Standard exclusion parameters were used. Of note was the exclusion of a large intravesicle median lobe. Transrectal HIFU using a 4-MHz transducer with the acoustic energy at the focal site adjusted to 1680 Wcm2. A fixed focal length of 3.0 or 3.5 cm was used. Most were treated using general anesthesia. A 4-s energy-on cycle followed by a 12-s energy-off interval was used.

The trial lasted 1 year, with interim reporting on 44 patients at 3 mo, and only 20 patients reported at 12 mo. Improvements in symptoms, urinary flow rates, and residual urine volumes were noted (Table 2). Four patients crossed over to transurethral resection.

Transient urinary retention was noted in 92% (46/50) of patients. Erectile function was not altered, but one patient had retrograde ejaculation. Other side effects were minor, except for one patient who had a

Table 2

Clinical Outcomes for High-Intensity Focused Ultrasound

Table 2

Clinical Outcomes for High-Intensity Focused Ultrasound

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