Sydney private hospital a first mover with breakthrough technology in urology

MedTech News: Healthscope’s Sydney Southwest Private Hospital (SSWPH) treated a patient with recurrent anterior urethral stricture disease with a novel medical device that aims to avoid or delay urethroplasty.

The procedure performed by urologist Dr Kayvan Haghighi using the Optilume Urethral Drug Coated Balloon is expected to have a significant impact on the treatment of anterior urethral stricture disease, offering an alternative, minimally invasive treatment option that traditionally would need frequent self-management, endoscopic retreatment or require open surgery.

General Manager of SSWPH, Jenny Connor, said of the successful surgery “At Sydney Southwest Private Hospital we pride ourselves on providing our patients with the best possible outcomes through world class facilities and specialists who are at the frontline of clinical innovation. The successful implementation of Optilume by Dr Haghighi gives us great confidence that this device will eventually become available to more patients who suffer from anterior urethral stricture disease. We are delighted that our patient is recovering well from surgery and we wish him all the best.”

Dr Haghighi recommended Optilume to his patient, after they had previously undergone several urethral dilation procedures only months apart. Although effective, those procedures only provided short-term relief due to the reformation of scar tissue and subsequent recurrence of the patient’s urethral stricture.

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The Optilume device used by SSWPH and under review by the Therapeutic Goods Administration (TGA), combines balloon dilation of the urethra with simultaneous delivery of an anti-proliferative drug to prevent recurrence of the blockage.

As the ROBUST 1 and ROBUST 3 clinical trials demonstrated, Optilume significantly reduces the incidence of stricture recurrence. At three years, durability continued with 77% freedom from reintervention rate, 176% increase in Qmax, and a 65% decrease in IPSS. As such, Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty.

David Baker, Director of Device Matters, the Australian distributor of Optilume, stated “We are excited to be able to provide [Urotronic’s] Optilume to Australian urologists and their patients during this period using the TGA’s Special Access Scheme pathway. We anticipate the TGA’s final assessment of our application for full approval early in 2022. Subject to full approval for use of the Optilume device in Australia, this technology has the potential to reduce burdens across the Australian healthcare landscape as a treatment that can be performed as a day procedure and provide a simple, safe and durable alternative treatment to existing methods.”

Urethral stricture is relatively common and, in many instances, is a debilitating disease estimated to affect millions of men globally. First line treatment for anterior urethral stricture, following appropriate clinical assessment, is typically performed endoscopically via urethral dilation or, more commonly, direct vision internal urethrotomy (DVIU). Clinical evidence and recommended guidelines state there is no statistically significant difference between the success of urethral dilation and DVIU. However, multiple endoscopic treatments of the same stricture are proven to lead to progressively worsening outcomes, recurrence, and retreatment. After a third endoscopic treatment, the failure rate approaches 100% two-years post-treatment.