Stesura Seveso Archivio Italiano di Urologia e Andrologia 2023; 95(4):12026 1 ORIGINAL PAPER INTRODUCTION Benign prostatic hyperplasia (BPH) is a disease of high prevalence and its natural history shows that 25% of men are affected by bothersome lower urinary tract symptoms (LUTS) caused by bladder outflow obstruction during their lifetime (1, 2). There are many devised treatment options to treat BPH. Initial medical therapy may be effec- tive for mild to moderate symptoms. Patients with moder- ate or severe symptoms may still require surgical inter- vention in presence of objective measurements that indi- cate greater obstruction. In the past, transurethral resection of the prostate (TURP) was considered the gold standard procedure for BPH treatment. TURP was associated with high rates of morbidity, including bleeding, sexual dys- function, stress incontinence, urethral strictures, and longer length of stay (3, 4). Recently, many innovative sur- gical procedures using thermal energy steam, or prostate artery embolization or mechanical dilation with UroLift have been introduced (5, 6). The aim of all of them is to maintain a strategic distance from the complications asso- ciated with TURP whereas keeping comparable results. Rezum is recommended for men ≥ 50 year of age with BPH and prostate volumes extending from 30 cm3 to 80 cm3. Its use is suggested for the treatment of enlargement of the central zone and/or a middle lobe. In general, the prostate is ablated through convective warm water vapor, pro- duced through radiofrequency (7, 8). This procedure has been detailed within the literature to result in a significant reduction in LUTS in patients with BPH, with high safety profile (9). Rezum has too illustrated advancement in symptoms scores compared to medical therapy (10, 11). Another recognized key advantage of Rezum treatment is the low rate of sexual affection post-operatively, which may be a watched key complication of other treatments for BPH, such as TURP (10). The aim of this study is to evaluate safety and efficacy of Rezum therapy as a mini- mally invasive modality for management of benign prosta- tic hyperplasia in patients with prostate volume < 80cc and those with prostate volume > 80cc. Objective: To evaluate safety and efficacy of Rezum therapy as a minimally invasive modality for management of benign prostatic hyperplasia in patients with prostate volume < 80cc and those with prostate volume > 80cc. Methods: Between June 2020 and February 2023, A total of 98 patients diagnosed with BPH and managed by Rezum were included in this study. Patients were divided based on their prostate volume of either less than 80 cc or greater than 80 cc. We evaluated several parameters related to their condition, including prostate volume, post-voiding residual (PVR) before and after surgery, number of treatments received, maximum urine flow rate (Qmax) before and after surgery and mean fol- low-up periods. Results: The mean age was 68 years (SD 11.2). The median prostatic volume was 62 cc (IQR 41, 17). A maximum of 9 treatments were administered. Six months was determined to be the average post-operative follow-up period (IQR: 3.5-7.2). The mean preoperative total PSA was 2.7 (IQR 1, 2), preopera- tive mean PVR was 79.8 cm3, preoperative mean Qmax was 8.2 ml/s (IQR 4.7-10.5), and median post-operative days until catheter removal was four days (IQR 3,1). Post-operative PVR was 24.7 cm3 (IQR 18.2, 29.4) and the mean post-operative Qmax was 18.3 ml/s (SD 6.3). Qmax levels significantly increased, by an average of 8.2 ml/s (SD 7.13) (p < 0.001). Similarly, a decrease of average PVR of 97.28 cm3 (SD 95.85) (p < 0.001) was detected, which is a substantial reduction. Between prostates less 80cc and those over 80cc, there were no appreciable differences in Qmax or PVR (p-values: 0.435 and 0.431, respectively). Conclusions: From our study, we conclude that Rezum water vapor thermal therapy, as a minimally invasive modality, is an effective and safe surgical option for management of benign prostatic hyperplasia of men with moderate to severe lower urinary tract symptoms (LUTS). This procedure has been shown to be effective in patients with varying larger prostate volumes. KEY WORDS: Hyperplasia; Prostate; Rezum. Submitted 24 October 2023; Accepted 11 November 2023 Evaluation of Rezum therapy as a minimally invasive modality for management of Benign Prostatic Hyperplasia: A prospective observational study Tamer A. Abouelgreed 1, 2, Ayman K. Koritenah 1, Yasser Badran 1, Ibrahim Tagreda 1, Mohamed Algammal 1, Hesham Abozied 1, Hany A. Eldamanhory 1, Hossam A. Shouman 1, Abdelhamid A. Khattab 3, Munira Ali 4, Mohammad Thabet Alnajem 5, Ahmed A. Abdelwahed 6 1 Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt; 2 Gulf Medical University, Ajman, UAE; 3 Department of Urology, Damanhur Teaching Hospital, Albuheira Government, Egypt; 4 Department of Radiology, Thumbay University Hospital, Ajman, UAE; 5 Department of Radiology, Tawam Hospital, Alain, UAE; 6 Department of Radiology, Ain shams University, Cairo, Egypt. DOI: 10.4081/aiua.2023.12026 Summary Archivio Italiano di Urologia e Andrologia 2023; 95(4):12026 T.A. Abouelgreed, A.K. Koritenah, Y. Badran, et al. 2 MATERIALS AND METHODS Between June 2020 and February 2023, a total of 98 patients diagnosed with BPH and managed by Rezum on the urology department of the institution of the Authors were included in this prospective observational study. All procedures performed in this study complied with institutional and/or national research council ethical stan- dards as well as the 1964 Declaration of Helsinki and its subsequent amendments or similar ethical standards. Protocols and written informed consent for all partici- pants were approved by the Research Ethics Committee of Thumbay University Hospital (affiliated with Gulf Medical University, REC #: 432/2020). Written informed consent was obtained from the patients for their anonymized information to be published in this article. The Rezum procedure utilizes the flow of water vapor to deliver heat to the prostate tissue in short bursts of 9 sec- onds. At our hospital, patients underwent Rezum therapy in the operating room under general anesthesia. Following the procedure, all patients had catheters of varying sizes inserted. The data collected included basic demographic information such as age and ethnicity, as well as preoper- ative and postoperative values. Additionally, we recorded the number of treatments administered, the time taken for catheter removal (TWOC), the average follow-up time, and any complications that arose. Due to non-compliance from some patients, it was not feasible to utilize standard- ized symptom questionnaires for assessment purposes. Furthermore, we categorized patients into two groups based on their prostate volume of either less than 80 cc or greater than 80 cc. Statistical methods The IBM Statistical Package for the Social Sciences (SPSS) software, version 25.0 (IBM Corp., Armonk, NY), was used to enter and analyze the data. Pre- and postoperative val- ues of parameters as PSA, Qmax, and PVR were compared. The Wilcoxon signed-rank test was applied since the change was negatively skewed and the data were paired. Statistics were judged significant at a 0.05 p-value. Additionally, we used a non- parametric Mann-Whitney U test to examine if the preoperative prostatic volume was connect- ed to the change in Qmax and PVR. RESULTS This prospective observational study comprised 98 patients with benign prostatic hyperplasia who underwent Rezum surgery at Thumbay University Hospital (affiliated to Gulf Medical University) between June 2020 and February 2023. The mean age was 68 years (SD 11.2) (Table 1). Overall, 54.2% (51/96) of the patients had prostate gland volumes that were less than 80 cc and 45.8% (45/96) of the patients had prostate gland volumes that were more than 80 cc. The mean prostatic volume was 69 cc (SD 34.19), while the median prosta- tic volume was 62 cc (IQR 41,17). A maximum of 9 treatments were administered, with a mean of 4.2 treatments into the median lobe. Six months was determined to be the average post-operative follow-up period (IQR: 3.5-7.2). The mean preoperative total PSA in our sample was 2.7 (IQR 1,2), mean preoperative PVR was 79.8 cm3, mean preoperative Qmax was 8.2 ml/s (IQR 4.7-10.5), and the median post-operative days until catheter removal was four days (IQR 3.1). Mean post- operative PVR was 24.7 cm3 (IQR 18.2, 29.4) and mean post-operative Qmax was 18.3 ml/s (SD 6.3) (Table 1). Qmax levels significantly increased, by an average of 8.2 ml/s (SD 7.13) (p < 0.001). Similarly a decrease of aver- age PVR by 97.28 cm3 (SD 95.85) (p < 0.001) was detect- ed, which is a substantial reduction (Table 2). Between prostates less 80cc and those over 80cc, there were no appreciable differences in Qmax or PVR (p-values: 0.435 and 0.431, respectively) (Table 3). Our study's complica- tions included two occurrences of urinary tract infections (UTI), which were treated with oral antibiotics, and five instances of hematuria, which resolved on its own. Due to the catheter's temporary post-operative presence, several patients experienced slight discomfort. None of the patients who underwent this treatment reported any sex- ual difficulties. Regarding the use of post-operative med- Table 1. General demographical data. Mean/median SD/IQR Age 68 11.2 Prostate volume 62 41, 17 Preoperative PSA total 2.7 1,2 Preoperative Qmax 8.2 4.7, 10.5 Preoperative PVR 79.8 42.4, 115.0 TWOC 4 3,1 Post-Op Qmax 18.3 6.3 Post-Op PVR 24.7 18.2, 29.4 Qmax: peak urinary flow; PSA: prostate-specific antigen; PVR: post-void residual; TWOC: time to removal of catheter. Table 2. Mean changes in Qmax and PVR. Mean SD Median Percentile 25 Percentile 75 p-value Change in Qmax 8.2 7.13 5.60 3.42 11.90 < 0.001 Change in PVR -97.28 95.58 -71.50 -142.00 -31.10 < 0.001 Qmax: peak urinary flow; PVR: post-void residual. Table 3. Mean changes in measures of Qmax and PVR in relation to prostate volume between the studied groups. Mean SD Median Percentile 25 Percentile 75 p-value Change in Qmax Prostate volume <=80 7.65 5.66 6.62 2.80 12.30 0.435 >80 12.88 13.10 6.10 3.20 28.10 Change in PVR Prostate volume <=80 29.3 25.8 22.2 15.8 28.4 0.431 >80 31.2 21.7 27.6 17.8 46.7 Qmax: peak urinary flow; PVR: post-void residual. Archivio Italiano di Urologia e Andrologia 2023; 95(4):12026 3 Therapy for management of Benign Prostatic Hyperplasia ications, patients stopped using their medications within three months of the procedure. DISCUSSION Benign prostatic obstruction (BPO) is one of the most fre- quently diagnosed conditions of the male genitourinary tract. Globally, BPO results in 1,2 million surgical proce- dures annually. The range of interventions available to treat BPH has broadened in recent years. Quality of life (QOL) and healthcare spending may be impacted in age- ing men because of LUTS due to enlargement of the Prostate (LUTS) (12). Rezum presented itself as a new sur- gical innovation, providing satisfactory clinical results while offering a safe and low-risk side effect profile (3). Its recommended by the the American Urological Association (AUA) and the European Urological Association (EUA). In addition to the existing interventions of prudent waiting and lifestyle modifications, pharmacotherapy, and surgi- cal management for LUTS, it has historically been diffi- cult for patients with BPH to remain compliant with the medical treatments offered (e.g. 5-alpha reductase, phos- phodiesterase, etc.). These treatments provide sympto- matic relief but at the expense of side-effects that threat- en compliance (3). In this study, we have highlighted the effectiveness of Rezum therapy through comparing the pre- operative and post-operative outcomes in our insti- tution among different patients with enlarged prostate including volumes greater than 80cc. Our study showed no significant difference in Qmax or PVR among prostate volumes of less than 80cc versus greater than 80cc. Historically, TURP has been the gold standard of BPH treatment. TURP provided patients with clinically mean- ingful improvements in LUTS. However, TURP’s major disadvantage is its complications, particularly bleeding and sexual dysfunctions (12). Rezum has several advan- tages over TURP. First, it improves clinical outcomes while maintaining sexual function. Second, it has mini- mal bleeding. Third, it can be performed without general anesthesia. This may be beneficial for some elderly patients. Fourth, it has been studied for cost-effectiveness in the USA compared to TURP long term follow-up, demonstrating that Rezum is comparable in health and cost-effectiveness (13, 14). While clinical improvement with TURP was increased, the literature has shown an overall cost reduction with Rezum due to the lower adverse effects (14, 15). Randomized control trials have also shown a reduction in symptomatic LUTS at four years with an average IPSS improvement with Rezum therapy of 47% (10). Lastly, due to COVID-19 and the benefit of reducing operative time, Rezum has proven to be a good choice with each procedure being reported to take about 17.5 minutes compared with 60-90 minutes for TURP (16). The efficacy of Rezum in the Arab popula- tion has not been extensively studied since the introduc- tion of this novel therapy. However, in the UK it has been reported on the preoperative experience of Rezum, as described in the study of Maximilian et al. (17). Our study has demonstrated the benefit of Rezum therapy amongst the Arab population, based on improvements in Qmax, PVR, and patient symptom reporting. Our population did not have any patient with catheter dependency, 29 of whom were on medical treatment (30.2%). Within 90 days’ post-operatively, our patients had discontinued their previous medications, this results going in line with the single office experience of Mollengarden et al. (18). Our study focused on postoperative changes in PVR and Qmax as objective measures of improvement in postoper- ative outcomes. At three months follow up, we observed a significant average increase in Qmax and a significant decrease in PVR, in line with other internationally pub- lished papers (17, 19). We also looked at the relationship between preoperative prostatic volume and changes in Qmax and PVR. In our sample, there was no statistically significant relationship. This was in contrast to Garden et al., who found that men with larger (> 80cc) prostates showed more profound Qmax and PVR changes than men with smaller prostates (< 80cc) (19). Medication side- effects can lead to patients not adhering to treatment for BPH; for example, Cindolo et al. (20), showed that adher- ence was 29% after one year of treatment with at least 6 months of therapy in a population based cohort study of 1,5 million men. In our experience, patients have only needed medical treatment temporarily after surgery, while no medications were needed for symptom control after 90 days from the procedure. This alone may increase the acceptance of the procedure and increase the adop- tion rate. In addition to reducing the need for medication and improving quality of life, Rezum is also a well-toler- ated procedure (21). One of the main drawbacks of tem- porary catheterization after surgery is that it can take an average of 4 days to heal, and our patients have reported discomfort during this time. In our study, complications have included UTI that was managed with antibiotics only, as well as four cases of spontaneous resolving hema- turia. No patients needed to be readmitted for any reason, and no patients reported sexual dysfunction up to the most recent follow-up. This is consistent with published data, as Dixon et al. found no clinically relevant changes in sex function over 2 years. McVary et al. reported a sin- gle treatment of water vapor therapy with no adverse effects on sex function over a 3-year period, which is in contrast to medical treatment that results in worsening erectile dysfunction and libido (9, 10). Lastly, the popu- lation that requires surgery for BPH includes an older group of men, many of whom may be on anti-coagulants and have multiple underlying conditions. Rezum is an excellent choice as it does not require the interruption of anticoagulants and does not require general anesthesia. Limitations. In our study median lobe size was not sufficiently meas- ured to adequately evaluate the effect of this measurement on outcome and response to Rezum. Our small sample size of patients with prostate size > 80cc emphasizes the need for larger, more robust prospective studies to elucidate Rezum outcomes in patients with larger prostates. CONCLUSIONS From our study, we conclude that Rezum water vapor thermal therapy as a minimally invasive modality is effec- tive and safe surgical option for management of benign prostatic hyperplasia of men with moderate to severe Archivio Italiano di Urologia e Andrologia 2023; 95(4):12026 T.A. Abouelgreed, A.K. Koritenah, Y. Badran, et al. 4 LUTS. This procedure has been shown to be effective in patients with varying larger prostate volumes. ACKNOWLEDGMENTS Thanks to Prof. Dr. Hossam Hamdy, President of Gulf Medical University for his suggestion. REFERENCES 1. Speakman M, Kirby R, Doyle S, Ioannou C. Burden of male lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyper- plasia (BPH) - focus on the UK. BJU Int. 2015; 115:508-519. 2. Lee SWH, Chan EMC, Lai YK. 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Rezum therapy for patients with large prostates (≥ 80 g): Preoperative clinical experi- ence and postoperative outcomes. World J Urol. 2021; 39:3041-8. 20. Cindolo L, Pirozzi L, Fanizza C, et al. Drug adherence and clin- ical outcomes for patients under pharmacological therapy for lower urinary tract symptoms related to benign prostatic hyperplasia: pop- ulation-based cohort study. Eur Urol. 2015; 68:418-25. 21. McVary KT, Holland B, Beahrs JR. Water vapor thermal thera- py to alleviate catheter-dependent urinary retention secondary to benign prostatic hyperplasia. Prostate Cancer Prostatic Dis. 2020; 23:303-308. Correspondence Tamer A. Abouelgreed, MD (Corresponding Author) dr_tamer_ali@yahoo.com; tamerali.8@azhar.edu.eg Department of Urology, Faculty of medicine, Al-Azhar University, Cairo, Egypt & Gulf medical university, Ajman, UAE Ayman K. Koritenah, MD dr_ayman.kotb@gmail.com Yasser Badran, MD dryasserbadran@gmail.com Ibrahim Tagreda, MD itagreda@yahoo.com Mohamed Algammal, MD gemykarter2020@gmail.com Hesham Abozied, MD aboziedhesham@gmail.com Hany A. Eldamanhory, MD drhanyeldamanhory@gmail.com Hossam A. Shouman, MD drhossamshouman@gmail.com Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt Abdelhamid A. Khattab, MD abdelhamed1123ufw@gmail.com Department of Urology, Damanhur teaching hospital, Albuheira Government, Egypt Munira Ali, MD muniraali1@gmail.com Department of Radiology, Thumbay University Hospital, Ajman, UAE Mohammad Thabet Alnajem, MD mtnajem@gmail.com Department of Radiology, Tawam Hospital, Alain, UAE Ahmed A. Abdelwahed, MD ahmed_abdelwahed@yahoo.com Department of Radiology, Ain shams University, Cairo, Egypt Conflict of interest: The authors declare no potential conflict of interest.