This section describes efficacy 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.
4.1 In a randomised controlled trial (RCT) of 206 patients comparing 140 patients treated by prostatic urethral lift against 66 patients treated by a sham procedure there was a significant difference in mean change in American Urological Association Symptom Index (AUASI) score (scores range from 0 to 35; higher score indicating greater severity) at 3‑month follow-up. The mean score decreased by 11 points at follow-up from a baseline score of 22 in patients treated by prostatic urethral lift and by 6 points at follow-up from a baseline score of 24 in patients treated by the sham procedure (p=0.003 difference between the groups).
4.2 A case series of 64 patients reported a significant improvement in International Prostate Symptom Score (scale 0 to 35; higher score indicating more severe symptoms) at follow-up intervals from 2 weeks to 24 months. The mean score improved from 22 at baseline to 13 at 2‑year follow‑up (n=33; p<0.001).
4.3 The RCT of 206 patients reported a significant difference in change in AUASI quality-of-life scores (scale 0 to 5; higher score indicating lower quality of life) at 3 months. The mean quality-of-life score decreased from 5 to 2 in patients treated by prostatic urethral lift and from 5 to 4 in patients treated by the sham procedure (p<0.001 difference between the groups).
4.4 The case series of 64 patients reported Sexual Health Inventory for Men scores (scale assesses erectile dysfunction, with scores ranging from 1 to 25, with 1 being the most severe and 25 being healthy). There was a statistically significant improvement in score in 26 patients (for whom results were reported), from 18 at baseline to 20 at 1‑year follow‑up (p=0.01).
4.5 The RCT of 206 patients reported a significant improvement in mean urinary flow rate at 3 months. The mean improvement in urinary flow was 4 ml/s in patients treated by prostatic urethral lift and 2 ml/s in patients treated by the sham procedure (from 8 ml/s at baseline for both groups; p=0.005 difference between the groups).
4.6 A case series of 19 patients reported a significant reduction in mean post-voiding residual volume, from 147 ml at baseline to 46 ml at 3‑month follow‑up (n=11; p=0.01).
4.7 The RCT of 206 patients reported retreatment at 1 year in 5% (7/140) of patients treated by prostatic urethral lift. Five patients underwent further prostatic urethral lift treatment because of insufficient response and 2 patients were treated by transurethral prostate resection (TURP) or laser vaporisation (reasons for retreatment not reported). The case series of 64 patients reported that 20% (13/64) of patients had further procedures. Four patients had TURP or photoselective vaporisation of the prostate within 7 months. Nine patients with symptomatic improvement after the initial procedure had TURP (n=4), photoselective vaporisation (n=4) or prostatic urethral lift (n=1) (at a mean of 13 months after the procedure) because of recurrent lower urinary tract symptoms.
4.8 The specialist advisers listed key efficacy outcomes as symptom improvement, improvement in quality of life, reducing or stopping medical therapy, flow improvement, reduction in post-void residual volume and maintenance of sexual and ejaculatory function.