Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Urinary tract infections (within 3 months of the procedure) were reported in 3% (4/140) of patients treated by prostatic urethral lift and 2% (1/66) of patients treated by a sham procedure in the randomised controlled trial of 206 patients (level of significance not reported).

5.2 Orchitis was reported in 3% (3/102) of patients in a case series of 102 patients (duration and timing not reported).

5.3 Symptoms of prostatitis (penile and perineal discomfort, pain on erection and ejaculation) were reported in 1 patient in the case series of 64 patients (treated with antibiotics).

5.4 Urinary retention (within 30 days of the procedure) was reported in 16% (3/19) of patients in the case series of 19 patients (reported as lasting median 3.5 days; no further details given).

5.5 Transient urge incontinence was reported in 8% (5/64) of patients in the case series of 64 patients (resolved within 8 days).

5.6 Incomplete voiding (within 30 days of the procedure) was reported in 1 patient in the case series of 19 patients (lasting 42 days).

5.7 Erectile dysfunction was reported within 30 days of the procedure in 11% (2/19) of patients in the case series of 19 patients. This spontaneously resolved after 23 days in 1 patient and 127 days in the other patient.

5.8 The specialist advisers listed bleeding, prostatic swelling and retention (needing catheterisation) as anecdotal adverse events. The specialist advisers considered vascular and rectal injury to be theoretical adverse events.