Do Patients Treated with Water Vapor Therapy and Meeting Randomized Clinical Trial Criteria Have Better Urinary and Sexual Outcomes Than an Unselected Cohort?

Abstract

Introduction:

Water vapor intraprostatic injection (Rezum procedure) for benign prostatic hyperplasia (BPH) is one of the most promising minimally invasive surgical treatments. Five-year outcomes from the multicenter randomized controlled trial (RCT) demonstrated significant and durable urinary and sexual function results in selected patients. We compared the sexual and urinary outcomes of this procedure in patients satisfying inclusion criteria of the RCT with unselected patients.

Materials and Methods:

We prospectively followed all patients with symptomatic BPH who underwent Rezum therapy at eight institutions and analyzed the functional results. Patients were divided into two groups: patients who matched the 5-year RCT inclusion criteria (Group A) and patients who did not (Group B). The pre- and postoperative data, complications, presence of antegrade ejaculation, and urinary and sexual outcomes were periodically recorded.

Results:

A total of 426 patients were eligible for the study (232 in Group A and 194 in Group B). Patients in Group B had a higher American Society of Anesthesiologists score, prostate volume, and postvoid residual measurement. No difference was found in terms of preoperative International Prostate Symptom Score, International Index of Erectile Function, maximum urinary flow, and prostate-specific antigen. Longer operative time and higher number of vapor injections were required in Group B, with no differences in hospital stay, injection density, and complication rates. All the urinary and sexual outcomes improved with no differences between the two groups. The reintervention rate at the latest follow-up visit was 2.6% in Group A and 3.1% in Group B.

Conclusions:

In our large multicenter series, water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patients' comorbidities.

Introduction

Water vapor thermal therapy (Rezum system) is one of the latest minimally invasive surgical treatments (MISTs) to treat lower urinary tract symptoms (LUTSs) due to benign prostatic obstruction (BPO). The 5-year outcomes from the multicenter randomized controlled trial (RCT) demonstrated significant and durable urinary function results without worsening clinical impact on erectile or ejaculatory function.^1,2

Based on this RCT and other prospective and retrospective series,^1
–3 the American Urological Association (AUA) considered the Rezum system as a treatment option for patients with prostate volume of 30–80 mL and bothersome LUTSs secondary to BPO (strength of recommendation: moderate; level of evidence [LE]: C) and for patients who desire preservation of erectile and ejaculatory function (strength of recommendation: moderate; LE: C).⁴

However, the study population had strict inclusion criteria (no history of urinary retention or previous prostate surgery for BPO; postvoid residual [PVR] ≤250 mL; prostate volume >30 and ≤80 mL; no use of antiplatelet or anticoagulant medication; and few comorbidities) and thus patients were slightly different from the majority of real-life patients. After proven efficacy and safety in selected cases, to overcome this caveat, several researchers reported their results in different clinical scenarios to consolidate and extend the indications to patients with large prostate, patients with indwelling bladder catheter, fragile patients, and patients with a history of previous prostate surgery for LUTSs.^5

–8

We previously reported our early results in selected cases with prostate volume >30 and ≤120 mL⁹ and the composite urinary and sexual outcomes in a series of patients with indwelling bladder catheter, prostate volume ≤120 mL, and use of antiplatelet and/or anticoagulant medications.¹⁰

The aim of this study is to compare the functional and sexual outcomes and safety profile of the Rezum procedure between patients satisfying inclusion criteria for the RCT and unselected patients in a large multicenter database.

Materials and Methods

From September 2019 to February 2022, we retrospectively reviewed all patients with moderate to severe LUTSs treated with Rezum (Rezum system, Boston Scientific, Marlborough, MA) for BPO in eight different Italian institutions. Informed consent was obtained from all patients before inclusion in the study. This study was approved by the institutional research ethics committee (Ref AOC-0020489-2022).

Surgical procedures were performed as previously described.^8,9 The type of anesthesia was in accordance with local protocols and patients' preferences and ranged from oral sedation to prostate block, intravenous sedation, or mild general anesthesia. Antibiotic prophylaxis was given to all patients according to local practice guidelines. At the end of the procedure, a bladder catheter was placed.

We examined the following pre- and postoperative factors: age, body mass index, American Society of Anesthesiologists (ASA) score, Charlson Comorbidity Index (CCI), use of antiplatelet and/or anticoagulant medications, LUTS therapy and history of catheterization or retention, prostate-specific antigen (PSA), prostate volume evaluated with transrectal ultrasound, presence of bladder stones or diverticulum and median lobe, uroflowmetry, PVR measurement, the International Prostate Symptom Score (IPSS), the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-UI SF), the Overactive Bladder Questionnaire–Short Form (OAB-q-SF) scores, and the International Index of Erectile Function (IIEF-5). Ejaculatory functions were also enquired.

Investigated intra- and perioperative factors were as follows: operative time, number of vapor injections, number of median lobe injections, injection density (defined as the ratio between prostate volume and number of injections), hospital stay, catheterization time, and reintervention rate.

Intraoperative adverse events are reported according to the Intraoperative Complication Assessment and Reporting with Universal Standards recommendations.¹¹

Complications were categorized as early (within 30 postoperative days) or late (after 90 days) and classified according to the modified Clavien–Dindo classification for transurethral resection of the prostate.¹² All the patients were recalled and underwent an outpatient clinic evaluation at least after 3, 6, and 12 months and then annually.

The study population was divided into two groups. Group A included patients who matched the preoperative inclusion criteria for the 5-year RCT (i.e., male; ≥50 years of age; IPSS ≥13; maximum urinary flow (Qmax) ≤15 mL/s; PVR ≤250 mL; prostate volume >30 and ≤80 mL; no mild or severe comorbidities; antiplatelet or anticoagulant medications; previous prostate surgery; bladder stone or cancer; urethral or bladder neck stenosis; bacterial or nonbacterial prostatitis in the last 1 and 5 years, respectively; and indwelling bladder catheter for 6 months),¹ with the exception of BPO therapies in progress.

Group B included all the remaining patients who had at least one of the RCT exclusion criteria (large prostate, presence of indwelling catheter, bladder stone or cancer, antiplatelet or anticoagulant medications, and comorbidities).

Statistical analysis

Continuous variables are reported as median and interquartile range (IQR) and categorical variables as absolute number and percentage. Statistical comparisons between real-life and selected patients were conducted at baseline, surgery, and follow-up using the Mann–Whitney test and chi-squared test, as appropriate. Comparisons between baseline and each follow-up were conducted using the Wilcoxon paired test. Statistical significance was set at p < 0.05.

Data were analyzed using IBM SPSS 28.0.1.0 (IBM Corp., Armonk, NY).

Results

A total of 426 patients were considered in our analysis; 54.5% in Group A and 45.5% in Group B. The follow-up period was similar in the two groups: 17 months (13–20) vs 15 months (13–19), respectively (p = 0.084). Patients' preoperative and intraoperative characteristics are reported in Table 1. Due to the inclusion criteria, a difference for antiplatelet or anticoagulant medications was found (p < 0.001). Furthermore, patients in Group B had a higher ASA score (p < 0.001) and CCI (p < 0.001). Median PVR and prostate volume were higher in Group B compared with Group A (85 vs 55 mL, p < 0.001).

Table 1.

Patients' Characteristics

	Group A (n = 232), n (%)	Group B (n = 194), n (%)	p
Age, years	64 (59–69)	64 (57–71)	0.597
BMI, kg/m²	24.8 (22.8–26.5)	25.6 (23.9–26.1)	0.405
ASA score
0	2 (0.8)	0	<0.001
1	101 (43.6)	55 (28.5)
2	120 (51.7)	114 (58.9)
3	8 (3.5)	22 (11.5)
4	1 (0.4)	2 (1.1)
CCI	1 (0–1)	1 (1–2)	<0.001
Prostate volume, mL	55 (45–65)	85 (51–100)	<0.001
Presence of median lobe	122 (52.6)	109 (56.2)	0.301
PSA, ng/mL	2.3 (1.4–3.5)	2.8 (1.6–4.2)	0.417
BPH treatment
None	8 (4.1)	33 (17.0)	<0.001
Alpha-blocker	172 (73.1)	109 (56.2)
5-ARI	3 (0.5)	9 (4.6)
Phytotherapy	5 (2.5)	13 (6.7)
Antimuscarinic	2 (1.0)	0
PDE5-I	2 (0.5)	1 (0.5)
Combination therapy	40 (18.3)	29 (15.0)
Antiplatelet/anticoagulant therapy
None	205 (100)	159 (82.0)	<0.001
Single antiplatelet	0	30 (15.5)
Double antiplatelet	0	2 (1.0)
Anticoagulant	0	2 (1.0)
Both	0	1 (0.5)
Acute urinary retention
Never	212 (91.3)	148 (76.3)	<0.001
Past episode	20 (8.4)	13 (6.7)
Bladder catheter in place	0	33 (17.0)
Retrograde ejaculation	152 (65.5)	120 (61.8)	0.792
Bladder stones	0	7 (3.6)	0.002
Bladder diverticulum	6 (2.6)	16 (8.2)	0.004
Previous urethrotomy	0	1 (0.5)	0.235
Incidental bladder cancer	0	3 (1.5)	0.047
Operative time, minutes	10 (9–14)	13 (10–15)	<0.001
Number of vapor injections	7 (4–8)	9 (6–12)	<0.001
Median lobe injections	1 (0–2)	2 (1–3)	<0.001
Injection density (injection number/prostate volume), mL	10 (8–10)	10 (8–11)	0.262
Catheterization time, days	7 (7–7)	7 (7–14)	<0.001
Hospital stay, days	0 (0–1)	1 (0–1)	0.581
Retreatment	6 (2.6)	6 (3.1)	0.808

Values expressed as median (IQR) or n (%).

ARI = alpha-reductase inhibitor; ASA = American Society of Anesthesiologists; BMI = body mass index; BPH = benign prostatic hyperplasia; CCI = Charlson Comorbidity Index; PDE5-I = phosphodiesterase type 5 inhibitors; PSA = prostate-specific antigen.

Preoperative IPSS and Qmax rate was similar for both groups (Table 2). In Group B, 17% of patients had an indwelling bladder catheter and 3.6% had bladder stones. One patient in Group B had previously undergone endoscopic urethrotomy. Group A patients with a history of BPO underwent treatment (p < 0.001) more frequently than patients in Group B, particularly alpha-blockers (73.1% vs 56.2%) and combination therapy (18.3% vs 15%).

Table 2.

Pre- and Postoperative Functional Outcomes

	Preoperative	3 Months	p	6 Months	p	12 Months	p	Last follow-up	p
QMax
Group A	8.3 (7.0–10.0)	13.8 (10.9–16.6)	<0.0001	14.9 (12.0–17.7)	<0.001	15.2 (12.5–17.8)	<0.001	15.6 (12.9–18.4)	<0.001
Group B	8.9 (6.2–11.5)	12.3 (10.4–16.1)	<0.001	13.2 (10.8–16.2)	<0.001	13.5 (11.1–16.5)	<0.001	14.8 (11.4–19.6)	<0.001
p	0.739	0.075		0.291		0.235		0.386
PVR
Group A	80 (50–90)	20 (3–48)	<0.001	20 (0–40)	<0.001	25 (10–40)	<0.001	20 (10–40)	<0.001
Group B	110 (70–150)	30 (10–60)	<0.001	40 (20–60)	<0.001	22 (10–60)	<0.001	30 (10–60)	<0.001
p	<0.001	0.319		<0.001		0.906		0.772
IPSS
Group A	22 (19–26)	12 (6–19)	<0.0001	8 (4–12)	<0.001	6 (4–9)	<0.001	6 (4–10)	<0.001
Group B	24 (18–26)	12 (6–18)	<0.001	10 (5–15)	<0.001	7 (3–10)	<0.001	7 (4–10)	<0.001
p	0.597	0.480		0.026		0.064		0.608
IPSS—QoL
Group A	4 (4–5)	2 (1–3)	<0.0001	1 (1–2)	<0.001	1 (1–2)	<0.001	1 (1–2)	<0.001
Group B	4 (4–5)	2 (1–2)	<0.001	2 (1–2)	<0.001	2 (1–2)	<0.001	2 (1–2)	<0.001
p	0.895	0.964		0.347		0.411		0.006
OAB-q-SF
Group A	36 (25–59)	24 (16–40)	<0.0001	21 (16–30)	<0.001	19 (15–24)	<0.001	16 (13–21)	<0.001
Group B	43 (29–63)	26 (20–41)	<0.001	24 (18–34)	<0.001	20 (16–25)	<0.001	19 (15–25)	<0.001
p	0.104	0.444		0.011		0.538		0.122
IIEF
Group A	20 (16–22)	20 (12–22)	0.400	21 (15–22)	<0.001	21 (18–23)	0.004	22 (20–23)	<0.001
Group B	19 (15–22)	19 (12–22)	0.546	20 (14–23)	0.034	21 (18–23)	0.006	22 (18–24)	0.040
p	0.496	0.717		0.236		0.973		0.906
ICIQ-SF
Group A	0 (0–1)	0 (0–1)	0.909	0 (0–0)	0.324	0 (0–0)	0.097	0 (0–0)	0.016
Group B	0 (0–1)	0 (0–1)	0.728	0 (0–1)	0.752	0 (0–1)	0.914	0 (0–0)	0.152
p	0.510	0.971		0.313		0.903		0.928	0.510

ICIQ-UI SF = International Consultation on Incontinence Questionnaire–Short Form; IIEF = International Index of Erectile Function; IPSS = International Prostate Symptom Score; QoL = quality of life; OAB-q-SF = Overactive Bladder Questionnaire–Short Form; PVR = postvoid residual; Qmax = maximum urinary flow.

Group B patients had longer operative and catheterization times and higher number of total vapor injections and median lobe injections compared with Group A, whereas no difference in injection density was found among the two groups (p < 0.001). No intraoperative adverse events have been reported.

The overall complication rate between the groups was similar (31% vs 26.2%); all the complications reported were Clavien I or II (Table 3), with only one case of blood transfusion in Group B. All urinary outcomes (IPSS, Qmax, PVR, prostate volume, quality of life (QoL), and OAB-q-SF) improved at 3, 6, and 12 months and at the last follow-up, with no differences between the two groups and no worsening of the ICIQ-UI SF score (Table 2).

Table 3.

Complications

	Group A (n = 232), n (%)	Group B (n = 194), n (%)	p
Intraoperative complications	0	1 (0.5)	0.126
Clot retention	4 (1.7)	3 (1.5)	0.838
Blood transfusion	0	1 (0.5)	0.217
Postoperative complications
AUR	23 (9.9)	19 (9.8)	0.461
Hematuria	2 (0.9)	6 (3.1)
Mild LUTSs	36 (15.5)	18 (7.7)
Severe LUTSs	6 (2.6)	5 (2.6)
Groin pain	1 (0.4)	1 (0.5)

AUR = acute urinary retention; LUTSs = lower urinary tract symptoms.

At the latest follow-up consultation, all patients remained catheter independent, with a significant decrease in prostate volume in Group A (55 mL, IQR 45–65; vs 34 mL, IQR 25–41; p < 0.001) and Group B (80 mL, IQR 51–100; vs 38 mL, IQR 27–61; p < 0.001). Patients in groups A and B reported a significant reduction in the retrograde ejaculation rate after the procedure (65.5% vs 11.6%, p < 0.001; and 61.8% vs 14.4%, p < 0.001; respectively), with no differences in ejaculatory restoration after Rezum treatment between the two groups (11.6% vs 14.4%, p = 0.367).

Moreover, the IIEF-5 improved 6 months after the procedure in both groups. The reintervention rate at the latest follow-up visit was 2.6% in Group A and 3.1% in Group B, with only four patients (0.9%) in the whole studied population reporting no improvement after the procedure and the remaining eight patients (1.7%) requiring further treatment after 1 year.

Discussion

Development of MISTs is the new frontier to treat LUTSs secondary to BPO. Mini-invasive treatment is not only suitable for old and fragile patients to avoid complications and hospitalization but also for younger patients who desire to preserve ejaculatory function with early recovery and less impact on their daily grind. After excellent results in terms of safety and sexual and urinary outcomes in the 5-year RCT, the Rezum system is considered a treatment option in the AUA guidelines for patients with prostate volume <80 mL and the desire to preserve sexual function.⁴

Moreover, other patient subsets are under investigation to understand the real advantages and limitations of this new technique. In the recent months, some retrospective series reported good results after Rezum treatment in fragile patients and patients with a large prostate, indwelling catheter, or history of prostate surgery.^5
–7 A recent systematic review considering 25 articles from 19 series regardless of study design and population (prostate size, PVR, indwelling bladder catheter, and comorbidity) reported that Rezum treatment guarantees urinary improvement independent of patient characteristics, with a good safety profile and low rate of sexual dysfunction.¹³

However, all these articles did not directly compare the results between different groups of patients. In our study, we analyzed differences between selected and unselected patients who do not fulfill the current criteria for Rezum therapy. We did not find any differences in IPSS, PVR, QoL, or Qmax improvement, and effectiveness was maintained at the latest follow-up despite higher prostate volume, PVR, and 17% with indwelling bladder catheter history in Group B.

We noted PVR reduction of 75% and 72% and improvement of Qmax of 87.9% and 66.3% in Group A and Group B, respectively. After treatment, we reported a significant reduction of retrograde ejaculation in both groups with no differences between Group A and Group B and persistent absence of ejaculation in 11.6% and 14.4% of patients, respectively. Of course, these data can be explained by drug withdrawal rather than a direct effect of Rezum treatment. However, 3.5% in Group A and 5% in Group B reported de novo anejaculation.

The reason for this phenomenon is multifactorial and, in part, due to the retrospective nature of the study and the absence of a standardized evaluation of ejaculatory function and sexual intercourse. Moreover, the IIEF-5 improved in both groups (+9%), but it reached statistical significance only after the first 6 months.

The improvement in erectile function, as for ejaculatory function, is debatable, with discordant results. In most studies, no differences were found in follow-up. Only four studies, as did ours, reported an improvement of IEFF score.¹⁴ Even if the 5-year RCT did not demonstrate an improvement in IIEF-5, it reported a gradual decline in sexual function from other causes, which were unrelated to the surgical treatment.²

Due to the higher prostate volume, operative time (13 vs 10 minutes) and number of vapor injections (9 vs 7) were slightly greater in Group B than in Group A, with no differences in terms of hospital stay or injection density. Catheterization time was favorable in Group A (p < 0.001), mainly because the bladder catheter was removed after 14 days in patients with a history of urinary retention. As reported in few studies,^15

–20 we noted a reduction in prostate volume after treatment (38% in Group A and 55% in Group B). This is in line with previous reports (range: 17.9%–34.9%).¹⁴

In our series, as reported in the literature,^3,13,14 complications are minor (Clavien I or II), with no differences between the two study groups. Only one case of blood transfusion occurred in Group B (0.5%), and a rate of 1.7% and 1.5% for clot retention (treated with bladder irrigation) was recorded in Group A and Group B, respectively. The retreatment rate was comparable between Group A and Group B (2.6% vs 3.1%, respectively), with only 0.9% of patients with no improvement after the procedure and the remaining 1.7% undergoing further treatment after 1 year. These data are in line with the retreatment rates within the 1st year, which were reported to fall between 1% and 3.4% by Babar¹³ and 2.4% by Whiting.²¹

This study has some limitations: the retrospective nature, involvement of different centers and several surgeons, absence of a standardized evaluation of ejaculatory function, and mid-term follow-up length.

Nevertheless, this is the first study comparing patients satisfying the RCT inclusion criteria with unselected patients, and it revealed no differences in terms of safety or urinary and sexual outcomes between these groups of patients undergoing the Rezum procedure. Further studies, especially RCTs, are needed to confirm our findings.

Conclusions

In our study, Rezum was confirmed as a safe and effective treatment independent of patients' characteristics.

Footnotes

Authors' Contributions

L.C. was involved in conceptualization, methodology, formal analysis, and review and editing. D.C. was involved in conceptualization, methodology, and writing—original draft. E.C., F.U., F.F., D.M., L.V., F.V., R.B., and G.F. were involved in data curation. S.M. was involved in methodology and formal analysis. G.S. was involved in conceptualization and writing—original draft.

Data Availability Statement

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author Disclosure Statement

L.C. received honoraria for surgical tutorship.

Funding Information

No funding was received for this article.

Abbreviations Used

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