Optilume for anterior urethral strictures

Level of innovation

Five experts agreed that Optilume is the first in a new class of procedures. Five experts also said that it is novel, and 4 said its safety and efficacy is not certain. One expert said the technology uses the same delivery method as endovascular drug-eluting balloons applied to the urethra. None of the experts were aware of any competing or alternative procedures available to the NHS. Two experts said that the novel aspect is the drug coating of the balloon, designed to inhibit fibrosis and reduce stricture recurrence. One noted that it falls between urethroplasty and urethrotomy. The experts were not aware of this technology being used in the NHS but 4 of them expected rapid uptake and use in the NHS.

Potential patient impact

The experts said that the procedure is less invasive than other treatments for the condition and that it can be done with local anaesthesia and does not require an overnight stay. One expert said that it can be done with local anaesthesia but it may be uncomfortable for patients. It can also reduce the number of procedures needed. Experts said that people with recurrent urethral strictures in the bulbar urethra up to 3 cm in length would particularly benefit from this procedure. One expert said that it is not suitable for longer strictures and that it has not been studied in the penile urethra in any detail. Two experts said it can be beneficial for people who do not want to undergo urethroplasty. One expert noted that there was anecdotal evidence from the US that this procedure could be used to treat urethral strictures at the level of the external urethral sphincter, which is not feasible with current treatment options.

Potential system impact

All experts agreed that this technology has the potential to change clinical outcomes. One expert said that in clinical practice people are usually offered repeat endoscopic dilation or urethrotomy. Benefits to the healthcare system include fewer invasive procedures and fewer hospital visits and follow-ups. One expert said that the operating time and recovery period can be shorter, which could improve patient flow and so reduce NHS waiting times.

All experts agreed that this technology has the potential to be cost saving compared with current standard care. One predicted a modest cost saving only. Three experts said that the technology could reduce resource use in terms of staff, equipment, and care setting. One expert said that it would likely have a minimal impact on resources but another said that the upfront cost of the balloon may be significantly more than a simple balloon.

Three experts said that no changes were needed to clinical facilities. One noted that sometimes during balloon dilation the balloon is filled with contrast so it can be imaged to make sure the balloon is fully inflated. A radiographer and image intensifier are needed for this. Another expert said that it should be possible to do the procedure outside the operating theatre.

All experts agreed that some training will be needed for surgeons using this technology, to ensure the correct positioning of the balloon and adequate inflation. One added that it is not a difficult procedure to learn. Four experts said that the first few cases should be supervised by someone who has experience with using the technology.

Risks and adverse events include urethral bleeding, urethral rupture, urinary tract infection, dysuria and recurrent strictures. Two experts said that the risks and adverse events are similar to standard care. One said that urethral rupture can be prevented by using X‑ray visualisation or endoscopic placement of a guidewire. Three experts expressed concerns about a theoretical risk of paclitaxel being released in the tissue. One noted that the amount of the drug on the balloon is not documented and there is no literature on the absorption of the drug into the blood. This expert also noted some concerns when paclitaxel has been used in angioplasty, in which it reduced the rate of stenosis but overall increased mortality. The expert expects a lower rate of absorption with this technology. The experts said the long-term effects of paclitaxel on human tissue need to be determined. One said that standard disposal protocols for biohazard products needs to be in place.

General comments

Five experts agreed that Optilume has the potential to replace current standard care. One said that it will be an additional treatment for short, recurrent strictures. Three experts noted it has the potential to replace urethroplasty for short strictures, and 2 said it could replace urethrotomy. One expert said that the lack of evidence on efficacy or safety may prevent the adoption of Optilume in the NHS.

Five experts said that this procedure will be carried out in most or all district general hospitals. Only 1 said that it will be used in a minority of hospitals. The prevalence of urethral stricture in the UK has been estimated at between 10 in 100,000 in younger men and 100 in 100,000 in men over 65. Five experts said that a large proportion of these will be eligible for this procedure: about 4,000 to 5,000 per year.

Three experts raised issues with the usability of the technology, including the costs, restricting it to appropriate cases, and the need for X-ray control, pinhole ureteroscopes or rigid cystoscopes. One expert noted that urethral strictures can be divided into 2 categories: bulbar strictures and strictures secondary to lichen sclerosus. Strictures secondary to lichen sclerosus are less likely to be affected by the technology because of ongoing inflammatory processes.

All experts agreed that further research is needed to address the uncertainties in the evidence base. Research should include randomised controlled trials in the UK and address long-term efficacy and safety. Three experts noted that research is currently underway, and 1 expert said that decisions to adopt this technology should be made after these trails are completed.