Advice
The technology
The technology
Optilume (Urotronic) is a drug-coated balloon indicated for treating anterior urethral strictures. The technology combines balloon dilation, to expand or widen the strictured area, with delivering an anti-proliferative drug (paclitaxel) to reduce stricture recurrence. Optilume is inserted under direct endoscopic vision (with or without fluoroscopy) and inflated under pressure. It stays inflated in position for up to 10 minutes. The balloon's inflation can be measured with a manometer, using radiography and inflation media, or with direct visualisation using cystoscopy. After the treatment has been delivered, the balloon is deflated, removed and safely disposed of.
Innovations
The company claims that Optilume is a novel treatment for urethral strictures because, as well as dilating the urethra, it directly treats the strictured urethra with paclitaxel. Paclitaxel limits the hyperactive cell proliferation and formation of fibrotic scar tissue that causes strictures to recur. The company claims that Optilume can reduce the rate of stricture recurrence and the need for retreatment (compared with standard balloon dilation or urethrotomy procedures) and reduce the need for urethroplasty, a more invasive procedure. The company also claims that Optilume is a minimally invasive procedure that may reduce operating and recovery time and is likely to have lower risks compared with more invasive treatments.
Current care pathway
Urethral stricture is a narrowing of the urethra, which restricts urine flow rate and can cause inflammation or infection. Treatment options depend on the site and length of stricture, age and general wellbeing. Treatment options include:
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Urethral dilation (widening) of the stricture using metal or plastic dilators. This is done endoscopically under local or general anaesthesia. A stricture can narrow again gradually after dilation, requiring repeat dilation.
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Urethrotomy. This is done endoscopically under general anaesthesia. About 50% of people have a successful widening of their urethral stricture after this procedure. The stricture can reform, leading to repeat procedures.
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Urethroplasty. This is offered if dilation or urethrotomy does not work. Urethroplasty is open surgery done under general anaesthesia and has a higher success rate in resolving urethral strictures, with no further treatment needed compared with existing standard endoscopic treatments.
A long course of antibiotics may be advised to prevent urine infections until a stricture has been widened.
The NICE guideline on lower urinary tract symptoms in men has been identified as relevant to this care pathway.
Population, setting and intended user
Optilume is used for treating anterior urethral strictures in adult men. The technology is intended for use in urethral strictures that need treating again after they have recurred after first-line endoscopic treatment.
The technology is used by trained consultants in urology, urology trainees and urology nurse specialists. It can be done using local anaesthesia as a day case or in an outpatient setting.
The company says that balloon dilation of the urethra without a drug coating is common practice in the NHS. But it offers additional training so that healthcare practitioners are fully compliant and audited for the Optilume procedure. Training is provided by the company free of charge.
Resource consequences
The technology is not yet used in the NHS. The company says that it is talking to NHS trusts and consultant urologists about adopting Optilume as part of their standard urethral stricture procedure.
The company says that adopting the technology will require minimal additional training and can be used in existing endoscopy settings. It claims that using Optilume could reduce the need for retreatments because urethral stricture is less likely to recur. It also claims that using the technology could be resource releasing in the NHS because of reduced bed days, operating theatre time, use of general anaesthesia, clinic appointments and ongoing treatments.