IntroductionBenign prostatic hyperplasia (BPH) is a common urological condition characterized byprogressive increase in the size of the prostate gland. It is a disease of ageing,affecting 40% of men in their 50s and 90% of men over 90 years. In a large proportion of BPH patients, prostate enlargement causes bladderoutflow obstruction (BOO), which results in lower urinary tract symptoms (LUTS).LUTS have a significant impact on quality of life (QoL) with symptom progressionoften correlating with progressive prostatic enlargement.

REZUM is an effective procedure that offers numerous advantages to many men with an enlarged prostate. It works for many men but not for all men.The success of treatment depends on patient characteristics including the severity of symptoms, size of prostate and severity of blockage caused by an enlarged prostate. What Can Be Done If REZUM for BPH Does Not Work?

– Furthermore, there is aconsiderable socioeconomic burden as it represents the most commonly presentingurological complaint.The current management algorithm for LUTS caused by BOO secondary to BPH includesconservative approaches (watchful waiting and lifestyle modifications),pharmacotherapy and surgical intervention. However, pharmacotherapy can produceunsatisfactory symptom relief. Furthermore, it can be associated with adverseeffects such as postural hypotension, asthenia and reduced sexual function. Surgical intervention remains the mainstay treatment for this clinicalproblem. While there are a number of options now available including Holmium laserenucleation of the prostate, UroLift and prostate artery embolization, transurethral resection of the prostate (TURP) is still considered the goldstandard intervention. However, TURP is not without its own limitations. Thisincludes a high complication rate and retreatment rate of 1–2% per year.

Complications include retrograde ejaculation (65%), erectile dysfunction(10%), urethral stricture (7%), urinary tract infection (UTI) (4%), bleedingrequiring transfusion (2%) and urinary incontinence (2%). – Furthermore, it requires the useof general or spinal anaesthesia and carries a mean hospital stay of2 days.,In order to improve this, several minimally invasive procedures have been developedwith the aim of providing alternative surgical strategies to TURP., Among these is the Rezum system(NxThera, Maple Grove, MN, USA), a novel ablative procedure, which has gainedincreasing attention since receiving United States Food and Drug Administration (USFDA) approval in 2015. This article outlines the evidence for Rezum with theobjective of assessing its usefulness through measures of efficacy, safety anddurability. The procedureIn contrast with other minimally invasive procedures that utilise conductive heattransfer, such as transurethral needle ablation or transurethral microwave therapy(TUMT), the mechanism of action for the Rezum system uses the principles ofconvective heat transfer that exploits the thermodynamic properties of water. The system comprises a radiofrequency (RF) generator and a single-usetransurethral delivery device, which incorporates a standard 4 mm 30-degreecystoscopy lens.

With the patient in a lithotomy position, an RF current is appliedto an inductive coil heater, producing thermal energy in the form of water vapour.Water vapour is delivered through a retractable vapour needle viaemitter holes in the transurethral device. This is done in 9-second bursts to the transition zone of the prostate,where, via convection, it diffuses evenly throughout the targettissue. The depth of the needle penetrating is approximately 10 mm. Upon contactwith body-temperature tissue, the water vapour then condenses. This phase shift to aliquid state dispenses concentrated energy onto the cell membranes of the targettissue, triggering instant cell necrosis. Overlapping injection sites can beestablished with repeated applications in order to fully target areas ofhypertrophy. Saline flush irrigation is used to both cool the urethra and to promote visualization.

The efficacy of the Rezum system has been assessed with gadolinium-enhancedmagnetic resonance imaging and histological testing post procedure. Both tests havedemonstrated the Rezum system to be successful at producing necrosis in targetedcell tissue while preserving non-treated tissue around the area, as the thermalenergy is contained within the zonal boundaries of the prostate., Mean reduction of total prostatevolume at 6 months post procedure was 28.9%.

Anaesthesia and sedation use is varied and used at the discretion of theclinician. Majority of patients received oral sedation only, approximately 1/5 ofpatients required prostate block and 10–20% required intravenous sedation.

ResultsThe results are provided in. Since US FDA approval in 2015 numerous studies on Rezum havebeen published, including one randomized controlled trial (RCT) with a 36-monthfollow up, one crossover trial and one pilot trial, with an additional recentlypublished retrospective study post-approval. – In 2016 a pilot trial by Dixonand colleagues, following up at 24 months demonstrated a mean change ofinternational prostate symptom score (IPSS) from 21.7 to 9.6, a mean improvement ofQmax from 8.3 ml/s to 12 ml/s and a mean change of post-void residual (PVR) from78.5 to 62.8 ml.

The results from the 5-year RCT, currently with a 3-year follow up, has showna mean improvement of IPSS of 11 points, a mean Qmax improvement from 9.7 ml/s to13.2 ml/s and a mean PVR improvement from 81.5 ml to 55.1 ml ( p. IIEF-EF, international index of erectile function; IPSS, internationalprostate symptom score; n/a, not applicable; NOS, not otherwisespecified; PVR, post-void residual; Qmax, urine flow rate; QoL, qualityof life; RCT, randomized controlled trail; UTI, urinary tractinfection.In most surgical treatments for BPH, a high incidence of negative impact onejaculatory function is common. The RCT conducted also measured sexual function,using the International Index of Erectile Function (IIEF-15) and the Male SexualHealth Questionnaire for Ejaculatory Function (MSHQ-EjD) as indicators. Patients whowere not sexually active were censored. A study by McVary and colleagues published data specifically on these outcomes using regression analysis toanalyse the results from baseline to 1 year. There was no device-related ortreatment-related cases of de novo erection dysfunction.

Notably,the ejaculatory bother score improved by 31% compared with baseline, and 27%achieved minimal clinically important differences in erection function at 1 year. A key strength of convective water vapour thermal therapy, therefore, seemsto lie in its ability to preserve sexual function.Potential further scope for the practical application of the Rezum procedure innontrial settings has been established by a recent, retrospective study.

The study analyses Rezum in 131 patients in the postmarket environment inmultiple medical centres. The selection criteria were at the discretion of theurologist. This included patients with varying prostate sizes (13–183 cm), patientswho had previously had invasive prostate treatment (including TURP and otherminimally invasive treatments) and patients in retention (PVRs ranged from 0 ml to2000 ml, mean 216.6 ml). The findings of this retrospective study are in line withthe outcomes from both RCT, crossover and pilot studies.

At 12 months, the mean IPSSfrom a baseline of 19.5 was reduced by an average of 9.4 points. This suggestssignificant symptomatic relief of LUTS symptoms. The use and subsequent success ofthe Rezum procedure in such a varied cohort that is not limited by prostate size,urinary retention or previous procedures highlights further potential uses of Rezumthat might fill a niche in the current arsenal of BPH treatment methods. However,more data collected over a longer period would be required to demonstratereproducible results. AdvantagesThe Rezum procedure has a number of advantages.

Firstly, it has been demonstratedto have substantial, prolonged symptomatic relief. The most extensive data werecollected for a period of 36 months, and patients in these studies were shown tohave sustained positive outcomes in IPSS, Qmax, PVR and QoL.

Moreover, these improvements in LUTS and urinary flow come without impactingtheir erectile and ejaculatory function typically associated with TURP. There have been no de novo cases of ejaculatory dysfunction reported in thedata so far reported., Gupta and colleagues have shown that compared with standard medical therapies, Rezum hadsignificantly better outcomes for QoL, IPSS and prostate volume. Compared withfinasteride monotherapy, Rezum had significantly improved Qmax, however this was notreplicated in comparison with doxazosin monotherapy or dual therapy.

Longer-termfollow up is needed to ensure the durability and replicability of the results seenin trial studies so far. IPSS, international prostate symptom score; PVR, post-residual volume;Qmax, urine flow rate; QoL, quality of life.Another significant benefit is that it can be performed as a day case procedure in anoutpatient setting. It has predominantly been performed under sedation, negating the need for a general anaesthetic. However, as the Rezum procedureis planned on rigid cystoscopy, which in the United Kingdom (UK) is predominatelycarried out under general anaesthesia, the success of day case Rezum procedures inclinical settings in the UK is yet to be established.Furthermore, there is a short resection time (average of 8 min) of Rezum, potentiallylimiting the window in which adverse events can occur, while maximising the number of procedures that can be undertaken. In contrastwith many other novel BPH therapies, Rezum is able to target and treat the prostaticmedian lobe.

This expands the potential patient cohort eligible for this procedure. In theory, there are no anatomical restrictions for Rezum and in the futureit is anticipated there will be evidence to support its application for largerprostate burdens. The current recommended cut-off of 120 cc is a reflection ofsurgeon and study experience to date. DisadvantagesIt is evident that the Rezum system has many strengths that endorse its use.

Despitethis, it is not without its disadvantages. A significant benefit of TURP is its usein incidental identification of prostate cancer, with positive detection on4.1–16.7% of TURP specimens. In contrast, Rezum does not collect tissue specimens; therefore, it lacks theability to ascertain incidental cases of prostate cancer. Furthermore, the nature ofthe exclusion criteria limits the number of patients who qualify for the procedure.Patients with urinary retention and large prostate burdens potentially would not beeligible, excluding a significant section of patient population.Catheterization post procedure is at the discretion of the clinician. In a pilottrial by Dixon and colleagues, 55% of patients were catheterized prior to discharge plus an additional 17%requiring catheterization post discharge, with an average duration of catheter useof 4.1 days. Of note, many of the sites involved in this trial adopted defaultposition of catheter placement.There is a lack of long-term follow up; currently, there is only one RCT providingdata for a period up to 36 months as part of a 5-year trial. It can be argued that further evidence and longer-term data are required todemonstrate that the benefits provided by Rezum can be sustained.

Furthermore, allevidence collected to date has been sponsored by NxThera (Maple Grove, MN, USA),which is a potential be a conflict of interest. Patient selection and procedure planningAs for all surgical procedures, patient selection is paramount.

Not every patientwith BPH are candidates for Rezum therapy. However, in contrast with someother procedures, patients with median lobe obstruction are eligible to receiveRezum therapy.

Critical factors that preclude patients from receiving Rezum therapyinclude previous surgical/radiation treatment involving the prostate, a history ofurinary retention and patients with a large prostate burden (120 cc). Prior tosurgery, in order to determine areas of prostate enlargement, patients undergoflexible cystoscopy. It potentially also provides an opportunity to assess thepatient’s tolerance to rigid cystoscopy while awake. Obtaining an ultrasound scan toassess prostate volume is also useful. ComplicationsThe majority of reported complications have been minor in nature (Clavien I–II).

Themost common adverse events are dysuria, haematuria, hematospermia, symptoms ofurgency and UTIs. These typically resolve within a few weeks.

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There have been no reportedcomplications at medium-term follow up and no reports of de novoerectile dysfunction.,However, the analysed data highlighted the presence of more serious adverse events(AEs). In their pilot trial, Dixon and colleagues reported a patient with threegrade 3b AEs wherein a patient had persistent LUTS symptoms with poor stream,frequency and urinary retention recorded as separate events; in this case, thepatient opted for TURP procedure at 42 days. A crossover trial found that two patients suffered three serious procedurerelated AEs collectively, including one patient who developed urosepsis postcystoscopy and on patient who suffered with bladder calculi and bladder neck contracture. Finally, a published RCT by McVary and colleagues in 2016 recorded twotreatment subjects having serious AEs: one patient had de novoextended urinary retention, a second patient was admitted to hospital overnight forobservation due to nausea and vomiting after taking alprazolam. CostCurrently, there are no available European studies providing cost-analysis dataassessing cost effectiveness.

Given its ambulatory status, potential cost-savingbenefits may be expected due to decreased length of hospital stay. Acost-effectiveness analysis report comparing therapies for LUTS symptoms has beenconducted in the US, comparing direct upfront cost and factoring in cost ofretreatment and treatment for AEs in relation to relative success rates (using IPSSdata collected over 2 years) of each therapy. Although estimated costs in the US are not directly comparable with those inEurope, this study suggests Rezum to be both a cost-effective and clinicallyeffective treatment for BPH. Although it does not provide as greater relief of symptoms as TURP, it hasthe benefits of incurring fewer upfront costs and AEs proving less costly overall,while maintaining good clinically efficacy. Interestingly, it was shown to be less costly and with fewer side effectsthan other minimally invasive therapies such as UroLift. Further prospective studies should include assessment of cost effectivenessof Rezum in comparison with other minimally invasive treatments, including cost ofprocedure, treatment of AEs, potential retreatment costs and patient lost workdays.

Further considerations and researchThe Rezum system is an exciting and novel minimally invasive therapy for treatingBPH, which thus far has demonstrated strong evidence of clinical effectiveness witha potential wide scope of use with limited drawbacks. However, it is important toconsider limitations in the current literature when assessing this noveltreatment.Previous trials have been supported or sponsored by NxThera (the producers of Rezum)which may represent a potential conflict of interest.

So far outcomes up to 3 yearshave been recorded, this is as part of a 5-year RCT currently ongoing. Long-termoutcomes are currently awaited so it is difficult to comment on the long-termefficacy of Rezum as a treatment for BPH and whether there will be continued successin relief of LUTS symptoms.

A reduction in prostate volume was noted, although nological explanation on lack of substantial reduction in PVR was noted, which needsto be explored in the future studies.Further evidence in a nontrial setting is needed in order to confirm theeffectiveness of Rezum in real-world applications and also to provide additionalsupport of findings published in a retrospective trial indicating the potential useof Rezum in patients with a large prostate burden and in urinary retention. ConclusionThe Rezum procedure is a novel minimally invasive therapy for treating BPH. So far,data from available studies point towards good clinical outcomes with a short-termrisk of self-limiting minor complications. Its application has demonstrated clinicaleffectiveness and possesses specific benefits that distinguish it among othertreatments. It is applicable to outpatient setting, is effective in preservingsexual function and is versatile in its ability to treat a variety of prostate glandmorphologies.