UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia

UroLift is effective with sustained clinical benefits, and the procedure is minimally invasive

4.1 The committee concluded that UroLift is clinically effective, with sustained symptomatic benefit and relief of lower urinary tract symptoms up to 5 years after treatment. It is implanted using a minimally invasive procedure. The clinical experts confirmed that in their practice, UroLift is an effective treatment which is well tolerated.

The UroLift procedure avoids the development of sexual dysfunction

4.2 The committee concluded that there was no evidence to suggest the UroLift procedure increases the risk of developing sexual dysfunction. The clinical experts explained that during the procedure there is no resection or ablation of prostate tissue. This is an important distinction between UroLift and other invasive treatments for benign prostatic hyperplasia. Therefore the committee considered that the reduced incidence of sexual dysfunction with Urolift, compared with comparator treatments, was plausible.

The person's preference is important in choosing an appropriate treatment for benign prostatic hyperplasia

4.3 The clinical experts explained that there are several invasive treatments for managing benign prostatic hyperplasia symptoms when drug treatment has not worked. Also, they explained that choosing an appropriate treatment is guided by what the person prefers because there is no definitive evidence that one treatment is better than another for all clinical outcomes. The committee noted that the updated evidence allowed direct comparison of UroLift with transurethral resection of the prostate (TURP). This evidence suggested that although the improvement in lower urinary tract symptoms may be greater after TURP the incidence of sexual dysfunction was lower with UroLift. The clinical experts explained that people for whom UroLift is considered suitable are also able to have Rezum treatment. The committee noted that there is only 1 study comparing Rezum with UroLift, in which the follow-up period was only 30 days. The results showed that UroLift was better than Rezum for the short-term relief of lower urinary tract symptoms and for improving erectile dysfunction, but any comparative benefits beyond 30 days were uncertain. The committee concluded that the use of UroLift was supported by the evidence. But, deciding whether to use this technology or other technologies should be guided by clinical expertise and counselling for the person having the procedure.

The evidence for using UroLift for people with an obstructive median lobe is limited but shows promising clinical effectiveness

4.4 The committee noted that some people have an obstructive median lobe. The clinical evidence for using UroLift for this population comprises only 1 small study of 45 people with a 12-month follow-up period. The results showed a statistically significant improvement in lower urinary tract symptoms and quality of life after UroLift without the development of sexual dysfunction. The clinical experts explained that they have successfully used UroLift to treat an obstructive median lobe. The committee concluded that the evidence was limited but promising for using UroLift to treat an obstructive median lobe.

Side effects and adverse events

Urinary tract infection is not a common complication after UroLift

4.5 The urinary tract infection rate after UroLift was 2.9% (Roehrborn et al. 2013). The clinical experts explained that the risk of urinary tract infection is, in their experience, lower with UroLift than with other procedures. This is likely to be because of the reduced need for urinary catheterisation after the procedure.

The treatment failure rate is low with UroLift

4.6 The clinical experts explained that UroLift has a good success rate in adequately relieving lower urinary tract symptoms. However, they considered that people should expect a failure rate of between 10% and 30%.

UroLift is an option for treating lower urinary tract symptoms caused by benign prostatic hyperplasia in the NHS

4.7 A clinical expert confirmed that UroLift is widely used in the NHS since the publication of the original NICE guidance. However, there are now other minimally invasive procedures available to treat the condition in the same population, such as Rezum.

UroLift can be done using general anaesthesia, or local anaesthesia with sedation

4.8 The clinical experts stated that in clinical practice, UroLift is done under either general anaesthesia or local anaesthesia with an anaesthetist present. They stated that the advantages of general anaesthesia are that the procedure can be done more quickly with less discomfort to the individual. When local anaesthetic is used, sedation and more time are needed to place the Urolift implants without causing unacceptable discomfort to the person. The clinical experts explained that doing flexible cystoscopy in the outpatient clinic to plan treatment is a good opportunity to assess tolerance and suitability for doing the procedure under local anaesthesia.

There are potential limitations for doing UroLift as an outpatient procedure

4.9 The clinical experts explained that they do not currently offer UroLift as an outpatient treatment. They expressed concerns about a lack of operational and recovery space in an outpatient environment and the increased potential for infection. The clinical experts stated that if these limitations were overcome, they would consider doing UroLift as an outpatient procedure but this is not current clinical practice.

There is uncertainty about the proportion of flexible cystoscopies carried out before a UroLift procedure

4.10 Two of the clinical experts stated that they used flexible cystoscopy routinely before deciding whether to offer UroLift. This allows them to see whether there is an obstructive median lobe and estimate the number of implants needed. They can also assess whether there are any other conditions, including bladder stones or bladder cancer, which might affect whether the procedure is done. One expert stated that they do not routinely use flexible cystoscopy before UroLift because of the added time and cost implications. There is some uncertainty about the proportion of flexible cystoscopies routinely carried out before the procedure.

The procedure time and length of hospital stay for UroLift can vary

4.11 The clinical experts agreed that on average, the UroLift procedure takes 10 to 15 minutes per person to do. However, they noted that this does not take into account variations in time taken for the administration of local or general anaesthetic or for changeover time between procedures. The clinical experts also noted that the length of hospital stay can vary because of local hospital procedures, the time taken to recover from the anaesthetic and for the person to empty their bladder (a requirement for leaving hospital).

Telephone follow up is routinely used for all procedures considered

4.12 The committee was informed that telephone follow up by a nurse was now routine with UroLift, Rezum, TURP and holmium laser enucleation of the prostate (HoLEP). People having Rezum, TURP or HoLEP also need to have a trial period without the urinary catheter in place, but the clinical experts explained that this is usually done in the community. The clinical experts also explained that people may return a few months after their procedure for objective tests to assess clinical outcomes such as flow rate and International Prostate Symptom Score.

UroLift is a minimally invasive procedure but may not be suitable for everyone

4.13 The clinical experts explained that TURP and HoLEP are unsuitable for some people with lower urinary tract symptoms, because of frailty or comorbidities. However, they considered that although UroLift is minimally invasive, it may be unsuitable for some people in poor health. Also, some people do not wish to have permanent implants. The clinical experts noted that the implants can sometimes leave traces on MRI scans, which may be confusing when people are being investigated for possible prostate cancer.

People who identify as women have had UroLift

4.14 The committee was informed that 8 people who identify as women have had UroLift treatment. One of these procedures was done in the NHS. The clinical experts stated that doing a UroLift procedure in people who have had gender reassignment surgery did seem possible.

UroLift is cost saving compared with standard treatments

4.15 The external assessment centre (EAC) revised the company's base case and showed that UroLift remained cost saving compared with the standard treatments, TURP and HoLEP. The committee accepted the EAC's conclusions. It noted that using UroLift is estimated to save, per person, £981 compared with bipolar TURP, £1,242 compared with monopolar TURP and £1,230 compared with HoLEP. This is over a 5‑year time horizon and if UroLift is done as a day-case procedure.

Follow up care for comparators affects UroLift's cost case

4.16 Further analysis was done to look at the use of telephone follow up for all treatments and a trial without a catheter in the community for Rezum. UroLift remained cost saving when all treatments had a telephone follow up instead of an outpatient appointment. Rezum and UroLift were cost neutral when there was a trial without a catheter in the community, instead of as an outpatient, after Rezum. The committee considered that it was not clear which assumptions relating to follow up care most closely resembled routine NHS practice and concluded that this introduced some uncertainty in the cost case between UroLift and Rezum.

The number of implants used affects UroLift's cost case

4.17 The economic analysis included an assumption that an average of 3.5 implants were used per person with UroLift treatment. The clinical experts thought this was an underestimate and that an average of 4 implants was more appropriate, with a range of between 2 and 6 implants depending on prostate size. The committee acknowledged that the economic model was sensitive to the cost and number of implants used. But varying the number of implants used was unlikely to affect the cost saving conclusions when compared with TURP and with HoLEP. It concluded, however, that the cost case compared with Rezum was less certain if the number of implants varied. The clinical experts commented that this may mean that using UroLift for smaller prostates, with no obstructive median lobe, might be cost saving when compared with Rezum.

It is uncertain whether UroLift is cost saving compared with Rezum

4.18 UroLift (if done as an outpatient procedure) was cost saving in the base case by £121 compared with Rezum for everyone who had treatment over a 5‑year time horizon. However, the EAC's sensitivity analysis showed that Rezum would be cheaper if several parameters were changed individually, including:

Further economic analysis was done to consider the use of flexible cystoscopy before UroLift treatment. It showed that Rezum was likely to be cost saving in this instance. However, there was uncertainty around whether only people being considered for UroLift would have flexible cystoscopy.

The cost case for UroLift when treating an obstructive median lobe is uncertain because of the increasing number of implants

4.19 The committee noted that somewhere between 5% and 20% of people have an obstructive median lobe. It understood that not everyone with an obstructive median lobe would be identified before the procedure. The committee discussed that having an obstructive median lobe made UroLift's potential case for cost savings for the full population uncertain. The base case for treatment of an obstructive median lobe included an average of 1.3 additional implants whereas the clinical experts believed the average to be 2 additional implants. This led to increasing uncertainty in the cost case for UroLift compared with Rezum. Rezum's cost is not affected by the presence of an obstructive median lobe.