Clinical and technical evidence

A literature search was carried out for this briefing in accordance with NICE's interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting

Published evidence

One study including 53 men is summarised in this briefing. It was a multicentre, single-arm, prospective open-label study investigating the safety and efficacy of Optilume.

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

The evidence is limited and of low methodological quality. The study is small in terms of patient numbers and was done in the Dominican Republic and Panama. Furthermore, Optilume is intended to be used without predilation so this study has limited applicability to an NHS setting. The evidence shows that Optilume is safe for the treatment of urethral strictures and early efficacy results are encouraging. The evidence came from 1 non-comparative study. High-quality comparative research is needed to evaluate Optilume.

Mann et al. (2020)

Intervention and comparator(s)

Intervention: Optilume.

Key outcomes

Forty-six men completed the 24‑month follow up. The mean number of endoscopic treatments before the study was 1.7. Before Optilume treatment, predilation was done with an uncoated balloon in 59%, direct visual internal urethrotomy (DVIU) in 15%, or a combination of the 2 in 26%. There was 'functional treatment success' (defined as an improvement of at least 50% in International Prostate Symptom Score [IPSS] without retreatment) in 32 out of 46 men (70%) at 24 months. Baseline IPSS improved from a mean of 25.2 to 6.9 at 24 months (p<0.0001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function. At 24 months, 39 out of 46 men (85%) had not needed a repeat intervention. There were no serious adverse events related to treatment at 2 years. There were 6 non-urinary serious adverse events but none were directly attributable to the device or procedure. In total, there were 71 adverse events, most commonly urinary tract infection (17%), fever (8%), dysuria (7%), acute urinary retention (6%) and headache (6%). Most were classified as mild (61%) or moderate (31%). Twenty-three per cent were categorised as 'possibly', 'probably', or 'definitely' related to the procedure or device.

Strengths and limitations

This is the first study of using a paclitaxel-coated balloon for urethral strictures. Optilume is intended to be used without predilation. However in this study strictures were pretreated with uncoated balloon dilation, DVIU or both until the urethral lumen diameter increased by 50%. The funding for this study included support from Urotronic and 3 authors are consultants for Urotronic.


The company claims that using technology could mean fewer consumables being used than is needed in standard care (DVIU or urethroplasty, or both). There is no published evidence to support these claims.

Recent and ongoing studies

The company and experts were aware of a potential new study comparing urethrotomy with 2 control arms.