3 Evidence

Clinical evidence

Relevant evidence comes from 4 studies presented in 10 publications, including 1 randomised controlled trial

3.1 Four studies were relevant to the decision problem in the scope:

  • 1 randomised controlled trial (5 publications: McVary et al. 2019, McVary and Roehrborn 2018, Roehrborn et al. 2017, McVary et al. 2016a, McVary et al. 2016b)

  • 1 prospective observational study (3 publications: Mynderse et al. 2015; Dixon et al. 2015, Dixon et al. 2016)

  • 2 retrospective observational studies (Mollengarden et al. 2018, Darson et al. 2017).

    The randomised controlled trial was in 197 people with an International Prostate Symptom Score (IPSS) of 13 or more and an estimated prostate volume between 30 cm3 and 80 cm3, who did not have urinary retention and who had no previous surgical interventions for their prostate. The observational studies included people with prostate sizes from 20 cm3 to 110 cm3 who had the Rezum procedure. All are non-UK studies.

The evidence suggests that Rezum is clinically effective

3.2 The Rezum II study showed that Rezum was associated with statistically significant improvements in lower urinary tract symptoms (LUTS) compared with sham at the 3‑month follow up. These improvements were maintained throughout 4 years of follow up. The treatment benefits of Rezum in relieving LUTS were also seen consistently in the observational studies. The incidence of sexual dysfunction after treatment with Rezum was low, with a few people reporting a decrease in ejaculatory function but little change in erectile function. Overall, the evidence base shows that Rezum is an effective treatment for LUTS in people with benign prostatic hyperplasia (BPH). Rezum also improved quality of life (McVary et al. 2019, Darson et al. 2017; Dixon et al. 2015 and 2016).

There is no evidence that directly compares Rezum with other interventions for BPH

3.3 None of the included studies compared Rezum with other commonly used treatments for BPH. Clinical experts suggested that more invasive treatments such as transurethral resection of the prostate (TURP) were likely to be associated with a more substantial relief of urinary symptoms than Rezum. But there is currently no direct evidence to support this. Similarly, there are no direct comparisons of Rezum with UroLift, holmium laser enucleation of the prostate (HoLEP), or GreenLight laser. Expert opinion indicated that recruiting participants to clinical trials that directly compare different minimally invasive and invasive treatments is challenging because people often say they prefer to avoid more invasive treatment.

An indirect comparison suggests that Rezum is as effective as UroLift

3.4 In the absence of direct comparative evidence, the company did an indirect comparison of Rezum and UroLift to relieve LUTS. This was based on the results of the Rezum II study and the Luminal Improvement Following prostatic Tissue (LIFT) study (Roehrborn et al. 2017b). Both technologies are minimally invasive procedures to treat LUTS, and the trial designs and study populations were similar. The main exception was that the Rezum II study included people with median lobe obstruction (31.1% of study participants) while the LIFT study did not. Results from the 2 trials indicated that the therapeutic effects of Rezum and UroLift in relieving LUTS were similar. Retreatment rates were different in the 2 trials: 4.4% for Rezum at year 4 and 13.6% for UroLift at year 5.

The clinical experts consider Rezum to be a safe procedure

3.5 The Rezum II study reported 3 procedure-related serious adverse events in the 3‑month follow up, including extended urinary retention, and nausea and vomiting, which were considered to be because of the sedative medication. An additional 3 procedure-related serious adverse events were reported with Rezum during the 3‑ to 12‑month follow-up period, including bladder contracture, bladder stone and urosepsis after cystoscopy. The clinical experts did not identify any specific safety concerns with Rezum.

Cost evidence

The company suggests that using Rezum is cost saving compared with other treatments for BPH

3.6 The company developed a decision analytic model with a time horizon of 4 years. The model compared Rezum with 4 comparators: TURP, HoLEP, UroLift, and GreenLight laser. The model assumed that all the technologies had equal efficacy in alleviating LUTS associated with BPH. The model incorporated a cohort Markov structure. Erectile dysfunction and urinary incontinence were included as permanent adverse events that inform long-term health states. The need for surgical retreatment for recurrence of LUTS was also considered. The results of the company model indicated that Rezum was cost saving by £737, £758, £532, and £25 per person when compared with TURP, HoLEP, UroLift, and GreenLight respectively over 4 years.

The external assessment centre's changes to the assumptions in the cost model reflect empirical evidence and expert opinion

3.7 The main parameters in the model were the technology costs, theatre time, hospital length of stay, adverse events and the need for another operation. The external assessment centre (EAC) adjusted some of the model's parameters, including the surgical retreatment rates and the adverse event rates, to reflect published empirical data and expert opinion.

The model estimates that Rezum is cost saving compared with TURP, HoLEP and UroLift but cost neutral compared with GreenLight

3.8 The EAC base-case results showed that Rezum was cost saving by £569, £651 and £497 per person compared with TURP, HoLEP, and UroLift respectively over 4 years. Rezum remains cost saving when all parameters are subjected to a one-way deterministic sensitivity analysis. In the base case, Rezum is cost incurring by £62 per person over 4 years compared with GreenLight laser. The model assumed that GreenLight, like Rezum, was used as a day case. If, in practice, this is not the case, then Rezum is anticipated to be cost saving. Overall, the EAC considered Rezum, therefore, to be approximately cost neutral compared with GreenLight over the course of 4 years.

Additional analysis suggests uncertainties in the cost saving when Rezum is compared with UroLift

3.9 In response to consultation comments on the draft recommendations, the EAC ran additional scenario analyses. These included different parameters relating to the current use of UroLift. The EAC also added the cost of catheter removal to the analysis to reflect that this is needed after Rezum but not after UroLift. The results showed that Rezum remains cost saving compared with UroLift when individual parameters are varied. But when all parameters are combined Rezum is cost incurring compared with UroLift. The probabilistic sensitivity analysis results indicate that there is uncertainty about whether Rezum is cost saving compared with UroLift.

  • National Institute for Health and Care Excellence (NICE)