4 Committee discussion

Clinical-effectiveness overview

Rezum is an effective minimally invasive procedure with clinical benefits

4.1 The committee concluded that the evidence from the Rezum II study demonstrated the effectiveness of Rezum in relieving lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a sustained benefit up to 4 years of follow up. The committee noted that this is supported by the results of the observational studies and by the results of a NICE patient experience survey that was provided to the committee. The committee noted that there are no studies that directly compare Rezum with other treatments in relieving symptoms in people with BPH, but considered an indirect comparison between Rezum and UroLift, that was drawn from analogous trial data. This suggests that Rezum is at least as effective as UroLift over 4 years. The clinical experts explained that these 2 minimally invasive procedures are used in similar cohorts of populations in clinical practice and that, in their experience, both procedures provide a similar degree of symptom relief. They pointed out, however, that Rezum is more versatile than UroLift in treating different shapes of prostate, for example in men with an obstructive median lobe.

Rezum should be used for men with moderate to severe LUTS with an estimated prostate volume of 30 cm3 to 80 cm3

4.2 The committee noted that there is one pivotal study that provides the evidence for the efficacy of Rezum. The clinical experts explained that Rezum II was a US study and designed to meet US Food and Drug Administration eligibility criteria. Its major inclusion criteria were: men aged at least 50 or over who have symptomatic BPH with an International Prostate Symptoms Score (IPSS) of 13 or greater, and with a prostate volume, measured by transrectal ultrasound, of 30 cm³ to 80 cm³. The committee concluded that there is limited evidence on the efficacy of Rezum in men outside this cohort. The clinical experts confirmed that, in their clinical practice, this cohort of patients corresponds closely to those that they treat with Rezum and that this encompasses approximately 75% to 85% of the overall population that need treatment to relieve LUTS. The clinical experts also explained that, for people with mild LUTS (IPSS less than 8), first-line treatment is medication or lifestyle change. For people with an estimated prostate volume 120 cm³ and greater, more invasive surgical interventions are recommended.

Rezum is unlikely to damage surrounding tissue and nerves, and sexual function is not affected in the short term

4.3 The clinical experts explained that loss of sexual function is an important concern for people undergoing invasive treatment for LUTS because the invasive procedure is likely to cause damage to nerves on the external surface of the prostate. They also explained that Rezum involves injecting steam into carefully directed and localised areas of the prostate from the inner, urethral surface of the prostate, and this may avoid nerve damage. The committee considered that the published evidence suggests that sexual function is retained after treatment with the Rezum procedure. It did note, however, a high incidence of sexual inactivity in people included in the Rezum II study and that overall sexual function showed a tendency to decline during study follow up. This may be attributable to the effect of ageing in the study population. Overall, the committee concluded that sexual function is preserved with Rezum, at least in the short term, and that this may be particularly important to people who are sexually active at the time of treatment. The committee was uncertain, however, about the impact of Rezum on longer-term sexual function because no data are available for longer than 4 years.

Quality of life is an important outcome when considering patient benefit

4.4 The evidence from the Rezum II study and observational studies indicated that treatment with Rezum with significant relief of LUTS is associated with a significant improvement in quality of life, which persists for up to 4 years of follow up. The clinical experts confirmed that, in their experience, people who underwent Rezum express a high level of satisfaction after the procedure.

Side effects and adverse events

Urinary tract infection is a common complication after Rezum

4.5 The clinical experts advised that complications that are encountered after the Rezum procedure include urinary tract infections (UTIs), bleeding, epididymitis and abscess. The clinical experts also explained that, after the Rezum procedure, a urinary catheter is left in place to allow the dead prostate tissue to drain away. The need for catheterisation, combined with the presence of necrotic tissue, are considered by the clinical experts to be predisposing factors for developing UTIs. This is higher for Rezum than UroLift, which does not need a post-operative urinary catheter. The clinical experts estimated that the risk of UTIs is around 5% to 7%, so a 5 to 7‑day course of prophylactic antibiotics is usually prescribed after the procedure. The committee concluded that post-procedure UTI rates associated with Rezum may be difficult to record because patients may present to their GP for treatment. It also noted that antibiotic use was not reported in the Rezum II study.

The rate of surgical reintervention is low with Rezum

4.6 The committee noted that the Rezum II study reported a 4.4% rate of surgical retreatment over 4 years of follow up. The clinical experts suggested that the average retreatment rate in their experience is around 3% after Rezum, and that retreatment is most likely in the first year after the procedure. The clinical experts explained that, because there is no direct view of the prostate cavity during the Rezum procedure, additional transurethral resection of the prostate (TURP) was sometimes needed to remove residual prostate tissue after Rezum. Overall, the committee noted that the retreatment rate with Rezum is low and compares favourably with similar treatments like UroLift.

Relevance to the NHS

The evidence for Rezum is broadly generalisable to the NHS

4.7 The clinical experts explained that Rezum is currently done in some NHS trusts and that there has been a popular demand by people for this procedure in some centres. The committee noted that the published evidence for Rezum is from studies that were done outside the UK. Nonetheless, the clinical experts explained that the study population included in the Rezum II study is similar to the people that they treat with Rezum in their own practice in the NHS. The committee concluded that the evidence is generalisable to UK NHS practice.

NHS considerations overview

Rezum is a day surgery procedure that can be done under local anaesthetic or light sedation but it may not be suitable for everyone

4.8 The clinical experts said there are currently 8 different treatments, including Rezum, available in the NHS for people with significant LUTS that have not responded to conservative therapy including medication and lifestyle changes. The clinical experts considered TURP to be the standard of care for LUTS secondary to BPH, but emphasised that treatments need to be offered to people on an individual basis guided by their individual circumstances. Key factors for consideration include: the availability of procedures in their local hospitals, age, prostate gland size and characteristics, and comorbidities. Rezum's advantages over other technologies are that it is a minimally invasive procedure that can be done under local anaesthesia or light sedation and that takes only around 20 minutes. People are therefore usually offered day case treatment. The clinical experts said that Rezum should be avoided in people with prostatitis or confirmed prostate cancer, in people for whom day case treatment is impractical or unsafe, and if there's a risk of increased bleeding, for example if they're having anticoagulant treatment.

Rezum is used to treat patients with benign prostate enlargement but there is no consensus on how to measure prostate size

4.9 The clinical experts said that an enlarged prostate that causes LUTS as a result of prostatic obstruction is caused by prostatic hyperplasia, which is a benign histopathological diagnosis. The clinical experts explained that there is currently no consensus on how prostate size should be estimated or measured in UK clinical practice. They considered that normally imaging would be used to estimate prostate size before surgically invasive treatment. The clinical experts said that imaging modalities could complement information from rectal digital examination of the prostate. Common imaging tools include transrectal ultrasound, cystoscopy and MRI. On the basis of these measurements, the committee heard that Rezum is usually offered to people with moderate prostatic enlargement with a prostate that is typically estimated to be 30 cm³ to 80 cm³.

The Rezum procedure is easy to learn

4.10 The clinical experts explained that urologists need specialist training to do the Rezum procedure. This training is provided by the company and includes lectures and simulation training. The clinical experts suggested that Rezum is relatively easy to learn and that the training requirement is minimal.

Cost modelling overview

Rezum is cost saving compared with other treatments for BPH but there are limitations in the cost model

4.11 The committee noted that the external assessment centre's (EAC) cost modelling results showed that Rezum is likely to be cost saving compared with TURP, UroLift, and holmium laser enucleation of the prostate (HoLEP) by more than £497 per patient over 4 years. The committee noted, however, that there are some limitations in the model, including the assumption that all treatments are equally effective in relieving LUTS. Indirect comparative data from the trials suggest that the technologies may not all reduce the IPSS score to the same extent. The clinical experts confirmed that more invasive procedures such as TURP, which removes prostate tissue, would be expected to have greater IPSS improvements. It's uncertain to what extent this impacts the need for retreatment. The committee identified other limitations in the cost model, including the fact that no consideration was given to the impact of urinary catheterisation and removal, or the need for antibiotics after Rezum. Nonetheless, the committee considered that these were unlikely to substantially affect Rezum's cost savings.

Main cost drivers

Doing Rezum as day surgery is the main driver for cost savings

4.12 Rezum is commonly done as day surgery and people are not usually admitted to hospital afterwards. The EAC considered that this was a key driver in the estimated cost savings when Rezum compared with traditional treatment options such as TURP. The company's model showed that the consumable cost of Rezum was estimated to be around £1,348 per person. The company provides the generator and servicing such as maintenance free of charge This cost relative to competitor treatments was also influential in the cost modelling results. The company representatives confirmed that they do not anticipate any changes to this cost model for the foreseeable future.

Cost savings

Rezum is cost saving compared with other treatments for BPH

4.13 The EAC did deterministic sensitivity and probability sensitivity analyses that varied parameters in cost models, and the results showed that Rezum remained cost saving. The committee concluded that, based on the published evidence, cost modelling and expert opinion, using Rezum is likely to lead to a cost of £497 compared with UroLift, £570 compared with TURP, and £650 compared with HoLEP, for every patient treated over a 4-year time horizon.

Further research

Further research will improve the evidence base for the efficacy of Rezum compared with surgical treatment

4.14 Further evidence to address the efficacy of Rezum compared with other surgical interventions would be welcome, including their relative impact on symptom relief, quality of life and preservation of long-term effect sexual function.

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Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia