These recommendations are in line with the guideline The management of lower urinary tract symptoms in men from the National Institute for Health and Clinical Excellence (NICE) [NICE, 2010].

Assessment of symptoms and excluding treatable causes

• These recommendations are pragmatic and based on expert opinion as NICE found no relevant clinical trials of assessment and exclusion strategies.

Active surveillance

• The recommendations on active surveillance are based on expert opinion as NICE found no relevant clinical or economic studies [NICE, 2010].

Conservative treatments

• The recommendations on conservative treatments (bladder training, post-void milking, maintaining a healthy lifestyle, containment products, and obtaining advice) are based on expert opinion, as NICE found no relevant clinical or economic studies [NICE, 2010].

Alpha-blockers

• NICE concluded that alpha-blockers are cost-effective for men with moderate-to-severe LUTS, are more cost-effective than 5-alpha reductase inhibitors in men with a normally sized prostate, and their benefits outweigh the adverse effects [NICE, 2010].
• Meta-analysis by NICE of 12 randomized controlled trials (RCTs) found that, compared with placebo, alpha-blockers reduced the symptom score, with a mean difference of –2.55 (95% CI –3.17 to –1.92). Although this difference is statistically significant, the 95% confidence interval includes the minimum clinically important difference.
• Economic studies found that alpha-blockers were cost-effective compared with placebo or no treatment in men with moderate or severe LUTS. NICE assessed the results as having minor limitations and being only partially applicable.
• RCTs found that alpha-blockers are more effective than 5-alpha reductase inhibitors.
• The quality of evidence from studies comparing alpha-blockers with antimuscarinics (anticholinergics) and phosphodiesterase-5 (PDE-5) inhibitors ranged from very low to low.
• RCTs found that more men treated with alpha-blockers than placebo experience dizziness, fatigue (asthenia), postural hypotension, rhinitis, erectile dysfunction, and abnormal ejaculation.
• The recommendations on follow up and monitoring are based on expert opinion as NICE found no relevant clinical trials.

5-alpha reductase inhibitors

• NICE concluded that 5-alpha reductase inhibitors may be cost-effective for men with large prostates, and that their benefits outweigh the adverse effects [NICE, 2010].
• RCTs found that 5-alpha reductase inhibitors were less effective than alpha-blockers in improving symptom scores and maximum urine flow in men with prostates estimated to be less than 30 mL, but were more effective in men with larger prostates (at least 30 mL, and 55 mL on average).
• RCTs found that, compared with alpha-blockers, 5-alpha reductase inhibitors are less likely to cause orthostatic hypotension, dizziness, fatigue or asthenia, and rhinitis, but are more likely to cause decreased libido, impotence, and breast enlargement.
• The recommendations on follow up and monitoring are based on expert opinion as NICE found no relevant clinical trials.

Combination of an alpha-blocker and a 5-alpha reductase inhibitor

• NICE concluded that combined treatment with an alpha-blocker and a 5-alpha reductase inhibitor may be more cost-effective than treatment with an alpha-blocker alone in selected people who are at higher risk of progression because of older age, more severe/bothersome symptoms, or greater prostate size. The recommendation was made on the basis of expert opinion weighing up the evidence on benefits, adverse effects, acceptability, and cost-effectiveness [NICE, 2010].
• RCTs found that alpha-blockers plus 5-alpha reductase inhibitor combinations are more effective than alpha-blockers alone in improving symptom scores at 2–4 years' follow up. The combination was not more effective at 6 months or 1 year.
• Men treated with alpha-blockers plus 5-alpha reductase inhibitor combinations were more likely than men treated with alpha-blockers alone to experience adverse effects (such as decreased libido, ejaculatory abnormalities, and impotence).

Antimuscarinics (anticholinergics)

• The recommendation to consider adding an antimuscarinic for persistent overactive bladder symptoms in men being treated with an alpha-blocker is based on one RCT included in the NICE systematic review [Kaplan et al, 2006; Kaplan et al, 2008], and a more recent RCT [Chapple et al, 2009].
• The first RCT had methodological weaknesses.
• The second RCT, which was placebo-controlled, found that men with bothersome overactive bladder symptoms while taking an alpha-blocker had statistically significantly greater improvements in diary variables, International Prostate Symptom Score (IPSS) storage scores, and symptom bother when an antimuscarinic (tolterodine ER) was added. However, there was no difference in the proportions of men whose Patient Perception of Bladder Condition (PPBC) score improved.
• Minor adverse effects (such as dry mouth) are common with antimuscarinics. Urinary retention is a serious possible adverse effect, but NICE found no evidence that this risk is clinically important.
• The recommendations on follow up and monitoring are based on expert opinion as NICE found no relevant clinical trials.

Referral

• The recommendations on referral are based on expert opinion as NICE found no relevant clinical trials.

Information on specialist treatments

• The information on specialist treatments is from the NICE guideline [NICE, 2010].