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. 2023 Nov 17;102(46):e36055. doi: 10.1097/MD.0000000000036055

Rezūm water vapor thermal therapy in patients with benign prostatic hyperplasia: Initial real-world data from Japan

Daisuke Obinata a,*, Junichi Mochida a, Rio Uehara a, Miyu Osawa a, Sho Hashimoto a, Ken Nakahara a, Tsuyoshi Yoshizawa a, Kenya Yamaguchi a, Satoru Takahashi a
PMCID: PMC10659603  PMID: 37986385

Abstract

Benign prostatic hyperplasia (BPH) is prevalent in older men. As surgery can be high risk in this group, minimally invasive procedures are preferrable. This study aimed to assess the initial results of minimally invasive Rezūm water vapor thermal therapy (WVTT) in patients with BPH. This single-center retrospective study included 25 consecutive patients with BPH who underwent WVTT between September 2022 and July 2023. Parameters including age, Charlson Comorbidity Index and Geriatric 8 (G8) scores, operative time, and number of vapor injections were evaluated. The International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score, and Core Lower Urinary Tract Symptom Score (CLSS) were used to assess symptoms before the procedure, and at 1 and 3 months after it. Urinary function indicators such as single voiding volume, maximum flow rate (MFR), and post-void residual volume were assessed at the same time points. The mean patient age was 76.0 years and the mean prostate volume was 54.8 mL. The mean G8 score was 14.4 and the Charlson Comorbidity Index score averaged 1.2. The mean operative time was 6.84 min, and included a mean of 4.8 vapor injections. Three months after WVTT, significant improvements were observed in the maximum flow rate (P = .02), post-void residual volume (P = .001), and urine volume (P < .001), as well as in the IPSS incomplete emptying (P = .01) and weak stream (P = .01) domains. No significant changes were observed in the remaining IPSS domains or in the Overactive Bladder Symptom Score or CLSS. This study provides the first report on Rezūm WVTT outcomes in Japan using the CLSS assessment tool. The initial results indicate a promising experience with this new treatment method. With a rapidly aging population, the incidence of BPH is expected to increase, making the minimally invasive Rezūm system a valuable addition to BPH treatment options.

Keywords: benign prostatic hyperplasia, Core Lower Urinary Tract Symptom Score, International Prostate Symptom Score, Rezūm water vapor thermal therapy

1. Introduction

Benign prostatic hyperplasia (BPH) is a long-term condition that affects many middle-aged and older men, causing urinary problems.[1] The incidence of symptomatic BPH is increasing worldwide owing to the aging population.[2,3] In October 2021, the proportion of the Japanese population aged 15 to 64 years was 59.4%, the lowest level since 1950 (https://www.stat.go.jp/data/jinsui/2021np/index.html).

BPH symptoms are caused by prostate enlargement and increased smooth muscle tension within the prostate, resulting in compression of the prostatic urethra. Bladder outlet obstruction caused by benign prostatic enlargement significantly affects patients’ quality of life.[4] Surgical interventions, most commonly transurethral resection of the prostate, are typically reserved for cases where pharmaceutical therapy has been unsuccessful or resulted in adverse effects such as urinary retention, urinary tract infection, hematuria, or bladder stones.[5,6] Up to 20% of patients undergoing transurethral resection of the prostate experience preoperative complications, and up to 7% and 3% develop postoperative urethral strictures and incontinence, respectively.[7] In Japan, according to the National Database Open Data, 30,957 surgeries were performed for the treatment of BPH in 2015; this figure decreased to 26,763 in 2019. This decrease in surgery despite the aging population suggests a preference for less invasive procedures.[8]

The introduction of insurance coverage for prostatic urethral lift in Japan in April 2022 and the Rezūm® System (Boston Scientific, Marlborough, MA) in September 2022 reflected a shift towards minimally invasive surgical techniques. The Rezūm® System administers water vapor thermal therapy (WVTT) to the prostate in 9 s bursts through a needle guided by cystoscopy. Steam energy penetrates the tissue, damaging cell membranes and resulting in immediate necrosis of the prostate tissue at the treatment site. The key benefits of this approach are its effectiveness, short procedure time, high safety profile, and ability to preserve sexual function. It is showing promise as a treatment for BPH, particularly in patients with multiple contraindications for conventional prostate surgery. Accordingly, in Japan, the Rezūm procedure is indicated for patients who are considered too high risk for traditional surgery for BPH. While the efficacy and safety of Rezūm WVTT have been established through multiple prospective and retrospective studies,[2,9–12] there is a paucity of information regarding initial treatment outcomes in patients with poor general health due to factors such as advanced age or complications; it is this population that is currently indicated for WVTT in Japan. This study aims to evaluate the clinical outcomes of the first patients treated with Rezūm WVTT at our university hospital, and therefore provide more substantial evidence regarding the effectiveness of this method.

2. Methods

This study included 25 consecutive patients with BPH treated at our institution between November 2022 and July 2023. The selection and exclusion criteria were based on the guidelines issued by the Japanese Urological Association, the Japanese Continence Society, and the Japanese Society of Endourology and Robotics. Briefly, the indications for WVTT included high-risk cases and patients who were not suitable for traditional surgery owing to their general health. Patients with significant hematuria or urinary tract infections were ineligible for WVTT. Prostatic urethral lift was introduced before WVTT became available in Japan and with similar indications; therefore, in all cases in this study, the option of prostatic urethral lift was presented to the patient, and the treatment modality was selected by shared decision-making.

All 25 patients underwent WVTT using the Rezūm system, with the procedure conducted as previously reported.[13,14] All medications, including alpha-1 blockers, were discontinued on the day of surgery and resumed the following day. Antithrombotic medications were discontinued prior to surgery and resumed the day after the operation. Antibiotics were administered from the day of surgery for 3 days. One week after the surgery, the urinary catheter was removed. Patients who underwent successful catheter removal completed uroflowmetry and various questionnaires 1 month postoperatively, followed by regular evaluations at 3 months postoperatively. In cases where catheter removal proved challenging, monthly examinations were conducted to attempt removal. If a significant amount of residual urine was observed, the catheter was reinserted. The study design was approved by the Institutional Review Board and Research Ethics Committee of Nihon University School of Medicine (RK-221213-2) and conducted in accordance with the tenets of the Declaration of Helsinki. Informed consent was obtained using the opt-out method.

The primary endpoint was the change in maximum urine flow rate (MFR) and post-void residual volume (PVR) at 1 and 3 months after the procedure, compared with preoperative values. In addition, data on age, Charlson Comorbidity Index score, Geriatric 8 (G8) score, operative time, and number of vapor injections were collected. The secondary endpoint was the change in symptoms at 1 and 3 months after the procedure, compared with before, as assessed by the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), and Core Lower Urinary Tract Symptom Score (CLSS). Single voiding volume, a urinary function indicator, was also assessed at the same time points.

Continuous data are presented as means with minimum and maximum values or standard deviations. Pearson’s correlation was used to investigate the correlation between operative time and the number of steam injections as well as prostate volume. For the comparison of continuous variables among the 3 different timepoints (preoperatively and at 1 and 3 months postoperatively), we utilized a non-parametric test for related samples, employing a two-way analysis of variance by ranks according to Friedman. Only results with a significance level of P < .05 were further analyzed with pairwise comparisons using the Bonferroni method. In some cases, it was not possible to obtain responses to the questionnaires, for example due to preoperative catheter placement, preventing us from pairing certain samples. However, all the data were included in the graphs. All statistical analyses were performed using SPSS Statistics for Mac version 28.0 (IBM Japan, Tokyo, Japan) and GraphPad Prism for Mac version 8.0 (GraphPad Software, San Diego, CA). Statistical significance was set at P < .05.

3. Results

Patient characteristics are presented in Table 1. The average age of the participants was 76.0 years, and the mean prostate volume was 54.8 mL. The mean G8 score was 14.4, and the mean Charlson Comorbidity Index score was 1.2. The mean operative time was 6.84 min, with a range of 3 to 16 minutes; this time has remained consistent since the procedure was introduced (Fig. 1A). The mean number of vapor injections was 4.8, with a range of 2 to 9, and there was no statistically significant correlation between the operative time and the number of vapor injections (Pearson’s correlation coefficient = .087, Fig. 1B) or the prostate volume (Pearson’s correlation coefficient = .182, Fig. 1B). In terms of the primary endpoint, MFR (5.1 ± 6.3 vs 7.9 ± 5.3, P = .02), PVR (185.7 ± 195.3 vs 80.0 ± 87.5, P = .001), and urine volume (71.0 ± 103.4 vs 169.1 ± 98.4, P < .001) were significantly improved 3 months after the operation compared with before (Fig. 2). All patients experiencing urinary retention underwent urethral catheter insertion. The number of cases of urinary retention decreased from 12 preoperatively to five at 1 month, and two at 3 months postoperatively; there were no cases of de novo urinary retention.

Table 1.

Patient characteristics.

Parameter n = 25
Age, yr 76.0 (62–87)
Body mass index, kg/m2 24.1 (19.6–29.3)
Prostate volume, mL 54.8 (30–86)
Geriatric 8 14.4 (10–17)
Charlson Comorbidity Index 1.2 (0–4)
Antithrombotic drug use, n (%) 11 (44)
Preoperative urinary retention, n (%) 12 (48)
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Data are presented as mean (min–max) unless otherwise stated.

Figure 1.

Figure 1.

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(A) Operative time for each patient, in chronological order. (B) Associations between operating time and prostate volume, and operating time and the number of vapor injections.

Figure 2.

Figure 2.

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MFR, PVR, and urine volume before (Pre) and at 1 and 3 mo (1M and 3M) after water vapor thermal therapy. *P < .05, **P < .01. MFR = maximum flow rate, PVR = post-void residual volume.

The incomplete emptying (2.20 ± 1.64 vs 1.17 ± 1.02, P = .01) and weak stream (3.20 ± 1.93 vs 1.60 ± 1.50, P = .01) domains of the IPSS were significantly improved 3 months after the procedure compared with before the procedure, as shown in Figure 3A. In contrast, there were no significant differences in either the IPSS storage domain or the OABSS (Fig. 3B). The majority of the storage symptom domains of the CLSS exhibited a decline at 1 month after surgery but displayed enhancement at 3 months postoperatively (Fig. 4A).

Figure 3.

Figure 3.

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(A) IPSS domain scores before (pre) and at 1 and 3 mo after (1M and 3M) WVTT. (B) OABSS domain scores before (pre) and at 1 and 3 mo after (1M and 3M) WVTT. Data are presented as mean with standard deviations. *P < .05, as determined using the Bonferroni method. IPSS = International Prostate Symptom Score, OABSS = Overactive Bladder Symptom Score, WVTT = water vapor thermal therapy.

Figure 4.

Figure 4.

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(A) CLSS domain scores before (pre) and at 1 and 3 mo after (1M and 3M) WVTT, presented as a radar chart. (B) Comparison bar chart showing the most distressing symptom as identified by each patient before (pre) and at 1 and 3 mo after (1M and 3M) WVTT. CLSS = Core Lower Urinary Tract Symptom Score, WVTT = water vapor thermal therapy.

Regarding the quality of life domain of the CLSS, the number of patients selecting “no particular distressing symptom” decreased from two before the surgery to one at 1 month, but increased to five at 3 months postoperatively. Similarly, the number of patients who selected “nocturia” as their most distressing symptom increased from three before the surgery to 10 at 1 month postoperatively, and then decreased to seven at 3 months postoperatively. Furthermore, the number of patients who reported “incomplete emptying” as their most distressing symptom decreased from three before the surgery to one at 1 month postoperatively; no patients selected this symptom at 3 months postoperatively. Additionally, no patients selected “pain” as their most distressing symptom 3 months after the procedure (Fig. 4B).

4. Discussion

BPH is prevalent among older individuals. Drug treatment is associated with a high discontinuation rate, with approximately half of patients discontinuing treatment within 2 years.[3,5] Moreover, discontinuation of alpha-1 blocker monotherapy or oral therapy increases the risk of requiring surgery.[5] Owing to this, and the aging population in Japan, the number of patients with BPH requiring surgery is expected to increase.

However, older individuals often have age-related health issues, such as osteoporosis and dementia, which affect multiple organ systems and increase the risks associated with surgery. Screening tools such as the Charlson Comorbidity Index and G8 can be used to evaluate these risks. The Charlson Comorbidity Index assigns a score based on the presence of complications, with higher total scores indicating a higher risk of complications.[15] The G8 is a functional assessment tool used to evaluate daily living and prognosis in older populations. A score of less than 14 generally indicates a poorer prognosis.[16] In our study the mean G8 score was relatively low at 14; the mean Charlson Comorbidity Index score was higher than 1. Therefore, minimally invasive surgical techniques were preferrable for the patients in our study, and are expected to become more common in countries with aging populations.

WVTT using the Rezūm System is a minimally invasive surgical approach that uses condensed water vapor energy to remove prostate tissue.[14,17,18] Several studies have investigated the effectiveness of WVTT, many using the IPSS, MFR, and PVR as assessment tools, with follow-up periods of up to 4 years.[12,17–24] Recent real-world data from Italy reported notable postoperative improvements in both sexual and urinary functions, and no early or late serious adverse events.[12] However, it is possible that previous studies have not examined the results of WVTT in the high-risk and older patients that make up our study population. We compared our findings with previous studies that evaluated patients at 1 and 3 months postoperatively.[17,18,20] Dixon et al[18] and McVary et al[20] observed a significant increase in the average Qmax value of MFR 1 month postoperatively. In contrast, our study, and that of Darson et al,[17] found no improvement in MFR 1 month after WVTT. An improvement was observed at 3 months, but to a lesser degree than that seen in the aforementioned studies.[17,18,20] Comparing other parameters, Darson et al,[17] observed a worsening in single voided volume at 1 month postoperatively, which returned to baseline at 3 months postoperatively. McVary et al[20] did not report any improvement in PVR. In contrast, our study demonstrated significant improvements in both single voided volume and PVR as early as 1 month postoperatively.

All three of these previous studies consistently reported improvements in the total IPSS scores: from approximately 20 preoperatively to approximately 15 at 1 month postoperatively, with further improvement to approximately 10 at 3 months postoperatively.[17,18,20] Similarly, the average preoperative total IPSS of 16.1 improved significantly to 12.8 at 1 month and 9.0 at 3 months in our study (Friedman with Bonferroni method, P < .05; Pre vs 1M and 3M). However, none of the aforementioned studies provided comparisons across the IPSS domains. Uniquely, our study revealed that improvements were predominantly driven by the voiding domain, which had the most significant impact on total IPSS score. Interestingly, McVary et al[20] reported improvements in overactive bladder symptoms, which were not observed in our study. A separate study reported no improvement in the IPSS at 3 months postoperatively.[19]

Given that the IPSS is multifactorial, a more detailed evaluation of urinary symptoms is warranted. We therefore incorporated into our study 2 symptom questionnaires developed in Japan, the OABSS[25] to evaluate overactive bladder symptoms and the CLSS,[26] which focuses on 10 core symptoms selected from a list of 25 established by the International Continence Society Standardization Committee. A noteworthy aspect of the CLSS is that patients select the symptom that most troubles them from among the 10 core symptoms, elucidating the specific urinary symptom characteristics of each individual. This enables a more detailed evaluation of the impact of WVTT on patients’ quality of life; our study is the first to evaluate quality of life immediately after surgery using CLSS. WVTT resulted in a decrease in incomplete emptying and an increase in urgency incontinence and nocturia. Interestingly, voiding pain was alleviated. These results may have differed from those of the IPSS because of the different wording of the questions, although the intended domains are the same. Therefore, the incorporation of the CLSS and OABSS allows for a more comprehensive assessment of symptoms.

Few previous studies have evaluated WVTT operative times. In this study, we discovered that Rezūm WVTT duration remained fairly consistent, regardless of prostate volume or the number of injections performed. This suggests that WVTT using the Rezūm System is easy to perform and may be implemented in various types of facilities.

This study has some limitations, as it was a single-center, retrospective study with a small number of patients. WVTT was introduced in Japan in September 2022 and is currently limited to high-risk cases, with the result that only a small number of patients have undergone this treatment nationwide since its implementation. However, as there is a lack of information and empirical evidence on the treatment outcomes of patients with compromised general health as well as Japan-specific data on the outcomes of this new treatment modality, studies in these patient cohorts are urgently needed. Despite the limited sample size in our study, significant improvements in urinary function and symptoms were observed in the early postoperative period. As the number of cases increases, we expect to confirm significant changes in other questionnaire domains that showed a trend toward improvement in this study. While future studies involving longer treatment durations and larger cohorts are needed, this study provides evidence to support the adoption of this new treatment modality in Japan.

In conclusion, this study provides the first report on WVTT outcomes in Japan using IPSS domains and the CLSS as assessment tools. These initial results from Japan, where a rapidly aging population is expected to drive an increase in the incidence of BPH, are promising. A further advantage of the Rezūm System is the short surgical time involved.

Acknowledgements

The authors thank Ms. Naoko Kodaka for secretarial assistance. We acknowledge technical assistance provided by Kazuki Yamanouchi. The authors would also like to thank Professor Seiichi Udagawa for his statistical advice. We would like to thank Editage (www.editage.com) for the English language editing.

Author contributions

Conceptualization: Daisuke Obinata, Rio Uehara, Sho Hashimoto, Ken Nakahara.

Data curation: Daisuke Obinata, Junichi Mochida, Miyu Osawa, Tsuyoshi Yoshizawa.

Formal analysis: Kenya Yamaguchi.

Funding acquisition: Daisuke Obinata, Satoru Takahashi.

Investigation: Daisuke Obinata, Junichi Mochida, Miyu Osawa.

Supervision: Kenya Yamaguchi, Satoru Takahashi.

Validation: Junichi Mochida, Tsuyoshi Yoshizawa, Kenya Yamaguchi.

Writing – original draft: Daisuke Obinata.

Writing – review & editing: Satoru Takahashi.

Abbreviations:

BPH
benign prostatic hyperplasia
CLSS
Core Lower Urinary Tract Symptom Score
G8
Geriatric 8
IPSS
International Prostate Symptom Score
MFR
maximum flow rate
OABSS
Overactive Bladder Symptom Score
PVR
post-void residual volume
WVTT
water vapor thermal therapy

This study was funded by the Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (grant numbers JP23K08789, JP19H03793, and JP19K09740).

This retrospective study was approved by the Institutional Review Board and Research Ethics Committee of Nihon University School of Medicine (RK-221213-2) and conducted in accordance with the tenets of the Declaration of Helsinki. Informed consent was obtained using the opt-out method.

The authors have no conflicts of interest to disclose.

The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.

How to cite this article: Obinata D, Mochida J, Uehara R, Osawa M, Hashimoto S, Nakahara K, Yoshizawa T, Yamaguchi K, Takahashi S. Rezūm water vapor thermal therapy in patients with benign prostatic hyperplasia: Initial real-world data from Japan. Medicine 2023;102:46(e36055).

Contributor Information

Junichi Mochida, Email: mochida.junichi@nihon-u.ac.jp.

Rio Uehara, Email: rio.u.nusm@gmail.com.

Miyu Osawa, Email: m1st.48694062@gmail.com.

Sho Hashimoto, Email: hashimoto.sho@nihon-u.ac.jp.

Ken Nakahara, Email: nakahara.ken@nihon-u.ac.jp.

Tsuyoshi Yoshizawa, Email: yoshizawa.tsuyoshi@nihon-u.ac.jp.

Kenya Yamaguchi, Email: yamaguchi.kenya@nihon-u.ac.jp.

Satoru Takahashi, Email: takahashi.satoru@nihon-u.ac.jp.

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