Interventional procedure overview of focal therapy using high-intensity focused ultrasound for localised prostate cancer
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Safety summary
Complications
In the systematic review of 20 studies, 12 studies reported that overall, 13% to 41% of people who had focal HIFU experienced some type of complication over median follow up ranging from 6 to 56 months. Most complications (85% to 100%) presented up to 3 months after the procedure (3 studies) and complications were mostly minor (80% to 100%; Clavien–Dindo grade I to II) and did not require any surgical intervention (9 studies; Bakavicius 2022).
In the analysis of a prospective registry of 1,379 people, there were a total of 83 (6.0%) complications. The rate of complications with Clavien–Dindo score >2 was 0.5% (7/1,379; Reddy 2022).
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, there were statistically significantly fewer complications in the focal HIFU group (37.5% compared with 66.7%, p=0.023; Byun 2022).
Urinary system complications
Urinary retention
In the systematic review of 20 studies, 8 studies reported acute urinary retention in 7% to 27% of people (Bakavicius 2022).
In a systematic review of 9 studies, 5 studies were included in a meta-analysis of urinary retention (He 2020). The pooled urinary retention rate for focal HIFU was 9% with no heterogeneity (I2=0%). There was no statistically significant difference in incidence of urinary retention with focal HIFU compared with whole-gland HIFU (9% compared with 11%; p=0.945; whole-gland HIFU meta-analysis based on 5 studies).
In the analysis of a prospective registry of 1,379 people, 10 people reported urinary retention (0.7%; Reddy 2022).
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, similar proportions of people had urinary retention in both groups (10.5% compared with 18.5%; Byun 2022).
Urethral sloughing
In the systematic review of 20 studies, 4 studies reported urethral sloughing in 7% to 43% of people (Bakavicius 2022).
Urinary tract infection
In the systematic review of 20 studies, 8 studies reported urinary tract infection (UTI) in 5% to 18% of people (Bakavicius 2022).
In the systematic review of 9 studies, 4 studies were included in a meta-analysis of UTI (He 2020). The pooled UTI rate for focal HIFU was 11% with moderate heterogeneity (I2=67%). There was a statistically significantly higher incidence of UTI with focal HIFU compared with whole-gland HIFU (11% compared with 7%; p=0.001; whole-gland HIFU meta-analysis based on 4 studies).
In the analysis of a prospective registry of 1,379 people, 52 people reported UTIs (3.8%; Reddy 2022).
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, similar proportions of people had UTIs in both groups (2.0% compared with 1.9%; Byun 2022).
Epididymitis
In the systematic review of 20 studies, 8 studies reported acute infective epididymitis in 2% to 8% of people (Bakavicius 2022).
In the analysis of a prospective registry of 1,379 people, 11 people reported epididymitis (0.8%; Reddy 2022).
Fistula
In the systematic review of 20 studies, 2 studies reported fistula in 0.3% to 3% of people (Bakavicius 2022).
In the systematic review of 3 studies on focal HIFU as a salvage treatment, 2 studies reported rectourethral fistulae in 2% to 3.6% of people (Khoo 2020).
In the analysis of a prospective registry of 1,379 people, 2 people reported rectourethral fistulae (0.1%; Reddy 2022).
Urinary obstruction
In the systematic review of 9 studies, 5 studies were included in a meta-analysis of urinary obstruction (He 2020). The pooled urinary obstruction rate for focal HIFU was 2% with no heterogeneity (I2=0%). There was a statistically significantly lower incidence of urinary obstruction with focal HIFU compared with whole-gland HIFU (2% compared with 15%; p<0.001; whole-gland HIFU meta-analysis based on 12 studies).
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, a statistically significantly lower proportion of people had bladder outlet obstruction and required endoscopic surgery in the focal HIFU group (15.8% compared with 35.2%, p=0.005; Byun 2022).
Stricture
In the systematic review of 20 studies, 3 studies reported Iatrogenic urethral stricture disease in 2% to 4% of people (Bakavicius 2022).
In the systematic review of 3 studies on focal HIFU as a salvage treatment, 1 study reported bladder neck stenosis in 8% of people (Khoo 2020).
Bladder stones
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, similar proportions of people had bladder stones in both groups (0.7% compared with 3.7%; Byun 2022).
Other complications
In the systematic review of 3 studies on focal HIFU as a salvage treatment, 2 studies reported pubic bone osteitis in 0.7% to 4.2% of people (Khoo 2020).
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, similar proportions of people had bleeding in both groups (5.2% compared with 5.6%; Byun 2022).
Functional outcomes
Urinary continence
In the systematic review of 20 studies, incontinence was defined as the use of any pad in 9 studies or more than 1 pad per day in 2 studies. The following continence rates were reported for focal HIFU (Bakavicius 2022):
3 months: 86% to 98% reported to be totally continent (3 studies).
6 months: 90% to 98% reported to be totally continent (6 studies).
12 months: 93% to 97% reported to be totally continent (6 studies).
In studies that used scales to assess continence, the following results were reported:
IPSS remained unchanged during the first 6 months after surgery (3 studies).
EPIC urinary domain: the incontinence score showed initial deterioration, although 6 months after the procedure, the score had returned to baseline (1 study) and remained high at 2 years (97% continent) and 3 years (98% continent) afterwards (1 study).
In the systematic review of 9 studies, 5 studies were included in a meta-analysis of urinary incontinence (He 2020). The pooled incontinence rate was 2% with no heterogeneity (I2=0%). There was a statistically significantly lower incidence of incontinence with focal HIFU compared with whole-gland HIFU (2% compared with 10%; p<0.001; whole-gland HIFU meta-analysis based on 13 studies).
In the systematic review of 3 studies on focal HIFU as a salvage treatment, 2 studies reported pad-free rates of approximately 87% (Khoo 2020). Leak-free rates ranged from 64% to 67.6%.
In an analysis of a prospective registry of 420 people, people were stratified into 2 cohorts – cohort 1 had 1 focal HIFU treatment; cohort 2 had 2 focal HIFU treatments (Lovegrove 2020):
Cohort 1:
There was a statistically significant decrease (implying better function) in mean IPSS from baseline to 1 to 2 years after the first focal HIFU (mean change -0.03, p=0.02).
There was no statistically significant change in mean IPSS from baseline to 2 to 3 years after the first focal HIFU, or from 1 to 2 years to 2 to 3 years after (both p>0.05).
There were no statistically significant changes in the proportion of people who were pad-free and leak-free continent after the first focal HIFU.
Cohort 2 (2 HIFUs):
There was a statistically significant decrease (implying better function) in mean IPSS from baseline to before the second focal HIFU (mean change -1.3, p=0.02).
There were statistically significant increases (implying worse function) in mean IPSS from before the second focal HIFU to 1 to 2 years after the second focal HIFU (mean change 1.4, p=0.03), and from before the second focal HIFU to 2 to 3 years after the second focal HIFU (mean change 1.2, p=0.003).
There were no other statistically significant changes in IPSS observed.
There were no statistically significant changes in the proportion of people who were pad-free and leak-free continent after the first focal HIFU.
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, the partial-gland ablation group recovered continence statistically significantly faster than the whole-gland ablation group (p=0.047; Byun 2022).
Erectile function
In the systematic review of 20 studies, erectile dysfunction was defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual intercourse (Bakavicius 2022). The following erectile function rates were reported after focal HIFU:
6 months postoperatively: 69% to 80% had retained sufficient erections for sexual intercourse (2 studies), and these rates remained stable (5 studies) or improved slightly (1 study) within the next 2 years.
In studies that used scales to assess erectile function, the following results were reported:
15-question IIEF questionnaire: initially decreased by 23 points in 1 study, with a gradual recovery during the early postoperative phase. 6 months after the procedure, the total score was still inferior by 17 points compared with baseline. In another study, 88% of people had normal erectile function at 12 months.
5 question IIEF: 1 study reported no deterioration in erectile function, while 2 other studies reported that 52% to 70% of people retained the same preoperative values on the IIEF-5 after the procedure. One study reported erectile dysfunction rates after a second focal HIFU, where retreatment was associated with a 7% increased erectile dysfunction rate.
In the systematic review of 9 studies, 6 studies were included in a meta-analysis of erectile dysfunction (He 2020). The pooled erectile dysfunction rate was 21% with moderate heterogeneity (I2=62%). There was a statistically significantly lower incidence of erectile dysfunction with focal HIFU compared with whole-gland HIFU (21% compared with 44%; p<0.001; whole-gland HIFU meta-analysis based on 8 studies).
In the systematic review of 3 studies on focal HIFU as a salvage treatment, 2 studies reported declines in IIEF5 scores. Tests of statistical significance were not reported (Khoo 2020).
In the analysis of a prospective registry of 420 people, people were stratified into 2 cohorts – cohort 1 had 1 focal HIFU treatment; cohort 2 had 2 focal HIFU treatments (Lovegrove 2020):
Cohort 1 (1 HIFU):
There was a statistically significant decrease (implying worse function) in erectile function score from baseline to 1 to 2 years after the first focal HIFU (mean change -0.4, p=0.02).
There was no statistically significant change in the proportion of people reporting erectile dysfunction (a score of 0 or 1 on question 2 of the IIEF) after the first focal HIFU.
Cohort 2 (2 HIFUs):
There were statistically significant decreases (implying worse function) in erectile function score from baseline to 1 to 2 years and 2 to 3 years after the second focal HIFU (mean change -0.8, p=0.005, and -1.1, p=0.008, respectively).
There was no statistically significant change in the proportion of people reporting erectile dysfunction (a score of 0 or 1 on question 2 of the IIEF) after the first or second focal HIFU.
In the retrospective cohort study of 152 people who had focal HIFU compared with 54 people who had whole-gland HIFU, there was no statistically significant difference in the recovery of erectile function between the groups (p=0.317; Byun 2022).
Anecdotal and theoretical adverse events
In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).
For this procedure, professional experts listed the following anecdotal adverse events: reduced volume of semen, dry orgasm, and perianal tear.
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