Expert comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

All 3 experts were familiar with the technology and 2 have used this technology before.

Level of innovation

Two experts said that the technology and its approach is innovative. One said that this is because it is a temporary device that makes 3 longitudinal incisions through pressure necrosis, remodelling the bladder neck and prostatic urethra and aiming to relieve the bladder outlet obstruction. Two experts said that it is novel but of uncertain safety and efficacy. One said that it is not novel because it has been in use in and out of trials for over 6 years.

Two experts were not aware of any competing technologies, with 1 saying that any competitors have a different mode of action. One expert said that, because it is a minimally invasive option, it can be compared to UroLift or Rezum.

Potential patient impact

All experts agreed that iTind has minimal side effects. Further patient benefits included no risk of negative impact on sexual function, no need for a permanent implant and that it can be done as a day case. All experts suggested patient groups that would particularly benefit from this technology. These included people who were unfit for general anaesthesia and people who did not want to accept the potential risks of impact on sexual or ejaculatory function, catheterisation or risk of incontinence.

One expert noted that about 20,000 bladder outlet cases are done in the UK and said that the exact proportion that would be eligible for iTind needs to be defined. Another expert said that about 10% to 20% of men presenting with LUTS caused by benign prostatic hyperplasia that needed surgical intervention would be eligible for iTind per year.

Potential system impact

Experts agreed that the technology has the potential to change the current pathway and lead to shorter waiting times. This is because the procedure takes less time, there is no need for specialist equipment or to use a theatre, minimal training is needed, and side effects are minimal.

Two experts agreed that iTind costs less than TURP. One said it may cost the same or less than Rezum or UroLift.

One expert said that no change in the existing facilities is needed because all the equipment used for iTind is available in all urology units. Two experts clarified that treatment rooms need to be available, plus lithotomy stirrups, a cystoscope and fluid for insertion.

Two experts noted that the company provides a training programme and support in the form of observing and then doing the procedure. One expert said that there is no formal training pathway in place and that this needs to be clearly documented.

General comments

All experts agreed that iTind is an alternative to the already existing treatment options and is unlikely to replace standard care.

None of the experts raised issues with the usability of iTind. However, they noted several issues that could prevent this technology being adopted in the NHS. These included cost, if it is not done as a day case or outpatient procedure, and the lack of a strong evidence base. One expert noted that longevity and reintervention rate always remain a question for minimally invasive surgical therapies including UroLift and Rezum.

One expert said that further research is needed, including a large multicentre randomised controlled trial. Another expert noted that the long-term efficacy needs to be proven against other minimally invasive treatment options.