Optilume Registry
Research type
Research Study
Full title
European Clinical Registry for Optilume® Urethral Drug Coated Balloon
IRAS ID
317662
Contact name
Monique Jansen
Contact email
Sponsor organisation
EAU RF
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
A urethral stricture is scarring in the urethra or surrounding tissue that narrows or blocks the passageway through which urine flows from the bladder. The stricture can result from inflammation, infection, or injury, and is much more common in men than in women. The scarring can occur anywhere between the bladder and the tip or opening of the urethra. In addition to uncomfortable urinary symptoms such as reduced flow rate and frequent urination, a urethral stricture can lead to complications that include urinary tract infections, prostatitis, urinary retention and kidney damage.
In Europe, the most common minimally invasive treatment for strictures is dilation or direct vision internal urethrotomy (DVIU). Balloon dilation allows less discomfort and reduced risks because of less shearing force and reduced trauma, compared to the traditional rigid dilators. More severe strictures can require surgical intervention for recurrent or long complicated lesions.
The most common complication after dilation is stricture recurrence, with average time to recurrence for a previously treated stricture being 3 months. Hazard function analysis showed that the risk of stricture recurrence was greatest at 6 months, whereas the risk of failure after 12 months was slight.Due to the high recurrence rate of strictures following dilation, treatment often progresses to more invasive treatments, namely urethroplasty which remains the gold standard of care, but it requires good expertise and is invasive.
This is a prospective, single-arm, open-label, multi-center, non-interventional post-market registry evaluating the Optilume DCB in a real-world patient population. As a non-interventional registry, enrollment will be limited to those subjects who, with the consultation of their treating physician, decide the Optilume Device is the appropriate therapy for treatment of their urethral stricture prior to the decision to participate in the registry. Participation in the registry and sharing of patient data will only be allowed after signed informed consent. Treatment and follow-up procedures will be conducted according to normal clinical practice.
Balloon dilation to treat urethral stricture is an established treatment and the risks associated with the procedure are well understood. The biggest risk of traditional dilation is recurrence of the stricture. The Optilume Device is a paclitaxel coated balloon that is supposed to suppress cellular proliferation and hence potentially mitigate the risk of recurrence of the stricture at the treatment site.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
22/YH/0212
Date of REC Opinion
27 Sep 2022
REC opinion
Further Information Favourable Opinion