Optilume for anterior urethral strictures

The technology described in this briefing is Optilume. It is used to treat anterior urethral strictures that need treating again because they have re-occurred after first-line endoscopic treatment.

The innovative aspects are that it incorporates balloon dilation with an anti-proliferative drug called paclitaxel, which is delivered around the inside surface of the urethra during the procedure.

The intended place in therapy would be as an alternative to standard care for urethral strictures.

The main points from the evidence summarised in this briefing are from 1 single-arm prospective study including a total of 53 men. It shows that Optilume is safe for treating urethral strictures, and early 2‑year efficacy results are encouraging.

Key uncertainties around the evidence or technology are that there are no comparative studies, the evidence has limited applicability to the NHS, and longer-term evidence is needed for Optilume, including the effect of paclitaxel on the tissues.

The cost of Optilume is £1,350 per unit (excluding VAT). The resource impact would be more than urethrotomy or dilation (£937) but less than urethroplasty (£4,300).