Outcomes of Rezūm therapy in young men: A multi-center study

Abstract

Objective:

The aim of this study is to evaluate the outcomes of the Rezūm procedure in men aged 50 years or younger, focusing on changes in urinary symptoms and quality of life.

Methods:

A prospective registry was created as part of the International Rezūm Registry database at two high-volume centers. The study reviewed data from patients monitored between April 2019 and August 2024. All patients aged 50 years or younger had their baseline medical and BPH history recorded, which included uroflowmetry measurements (Qmax and PVR) and validated questionnaires such as the International Prostate Symptom Score (IPSS), IPSS Quality of Life (QoL), Benign Prostatic Hyperplasia Impact Index (BPHII) and International Index of Erectile Function-15 (IIEF-15). Data were collected at baseline and at 3, 6, and 12 months following the procedure.

Results:

Fourteen patients were included, with a mean age of 49.6 years (SD 1.05). The mean baseline prostate volume was 54.3 cc (SD: 22.0). At baseline, the mean IPSS was 24.3 ± 5.9, which significantly improved to 10.5 ± 5.8 at 6 months and 11.6 ± 5.4 at 12 months. The IPSS QoL score improved from 4.8 ± 0.9 at baseline to 2.4 ± 1.7 at 12 months. Qmax increased from 7.9 ± 4.5 mL/s to 17.8 ± 6.1 mL/s at 12 months. PVR decreased from 197.6 ± 270.2 mL to 51 ± 77 mL at 12 months. IIEF scores showed no significant differences.

Conclusion:

The Rezūm procedure demonstrates significant efficacy in improving urinary symptoms and quality of life in men under 50.

Introduction

The global prevalence of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) is estimated at 26.2%, with rates increasing significantly with age—from 20% in men aged 50–59 years to 38.4% in those aged 80 and older. ¹ BPH, a common cause of bladder outlet obstruction, often results in bothersome LUTS that can substantially impair quality of life . ² Beyond symptom burden, prostate enlargement may also lead to serious complications, including urinary retention, recurrent urinary tract infections, and even renal insufficiency.^3,4

Traditionally, transurethral resection of the prostate (TURP) has served as the surgical standard of care for patients. However, TURPs are associated with undesirable side effects like urinary retention, incontinence, strictures, infections, erectile dysfunction, and retrograde ejaculation. ⁵ The past few decades have seen the development of several alternatives to TURPs, including water vapor thermal therapy. This treatment modality, known as Rezūm Water Vapor Thermal Therapy, has emerged as a significant minimally invasive option for managing BPH-related lower urinary tract symptoms (LUTS). ⁶

A comparison between Rezūm therapy and transurethral resection of the prostate (TURP) demonstrated that Rezūm is associated with significantly shorter operative times and less intraoperative bleeding. Furthermore, improvements in International Prostate Symptom Score (IPSS), quality of life (QoL), and maximum urinary flow rate (Qmax) were comparable between the two procedures at both 6-month and 1-year follow-up. ⁷ Supporting its safety profile, a recent expert consensus emphasized that adverse events related to Rezūm therapy are predominantly transient and low-grade (Clavien-Dindo <3). ⁸

Rezūm therapy, a minimally invasive procedure with well-established benefits and a low risk of adverse events, presents an excellent surgical option for young patients with BPH-related LUTS. ⁹ Its shorter operative time and minimal impact on sexual function make it particularly appealing to younger men with fewer comorbidities and demanding schedules. ¹⁰ This study aims to evaluate the efficacy of Rezūm therapy in men under 50, focusing on its effects on urinary and sexual function.

Methods

Study subjects

This study is a retrospective review of a prospectively collected database from two high-volume centers performing water vapor thermal therapy (WVTT-Rezūm) in Canada and Italy. Institutional ethics board approval was obtained at each center. The cohort included patients who underwent Rezūm therapy between April 2019 and August 2024, with eligibility restricted to those aged 50 years or younger.

Rezūm water vapor thermal therapy was performed according to previously established methods. ¹¹ Each application of water vapor ablated contiguous regions of prostatic tissue, following the urethra’s natural gradient. The number of injections was determined at the surgeon’s discretion based on the patient’s prostatic anatomy and the goal of preserving ejaculation. Patients were discharged the same day with a Foley catheter in place. The duration of catheterization was 7 days.

Data collection and outcomes of interest

Patients were evaluated at baseline, 3, 6, and 12 months. Collected data included patient demographics, prostate volume, number of Rezūm injections, procedure-related complications, and BPH medication usage at baseline and follow-up. Clinical assessments comprised the International Prostate Symptom Score (IPSS) and its Quality of Life (QoL) subscale, the International Index of Erectile Function (IIEF-15), maximum urinary flow rate (Qmax) and post-void residual volume (PVR).

The primary outcome was the effectiveness of Rezūm therapy in improving urinary symptoms and objective measures of urinary function, as assessed by IPSS, IPSS QoL, Qmax, and PVR. These outcomes were evaluated in relation to baseline and follow-up data collected throughout the study period. Secondary outcomes focused on sexual function, assessed using the IIEF-15 to evaluate the therapy’s impact on male sexual health.

Statistical analysis

Patient characteristics and outcomes were analyzed descriptively. Continuous variables were compared using Student’s t-test or rank-sum tests, depending on data distribution. Categorical variables were analyzed using Fisher’s exact test. All statistical analyses were conducted using Stata 18BE, with a two-sided p-value < 0.05 considered statistically significant.

Results

A total of 14 patients who underwent the Rezūm procedure were included in this analysis. The mean age at the time of the procedure was 49.6 years (SD: 1.05). The mean baseline prostate volume was 54.3 cc (SD: 22.0). A median lobe was present in seven patients (50%). Five patients (35.7%) were on alpha-blockers, and two patients (14.3%) were on 5-alpha reductase inhibitors. The procedure involved a mean of 7.3 vapor injections (SD: 4.0). The mean duration for scope in-and-out was 5.6 min (SD: 4.3).

Baseline characteristics are shown in Table 1.

Table 1.

Baseline characteristics.

Variable	Full Sample (n = 14)
Age
Mean (SD)	49.6 (1.05)
Median	50
Range (min-max)	(46–50.0)
Median lobe – n (%)	7 (50.0%)
Hypertension – n (%)	0 (0.0%)
Diabetes – n (%)	0 (0.0%)
History of urinary retention – n (%)	3 (23.1%)
Baseline prostate volume
Mean (SD)	54.3 (22.0)
Median (Q1–Q3)	50.2 (40.0–70.8)
Range (min-max)	(16.9–87.0)
Currently using foley catheter – n (%)	2 (14.3%)
Alpha blockers – n (%)	5 (35.7%)
ARI Inhibitors – n (%)	2 (14.3%)
Anticoagulants or antiplatelet - n (%)	1 (7.1%)
Total no. vapor injections
Mean (SD)	7.3 (4.0)
Median (Q1–Q3)	6.0 (5.0, 8.8)
Range (min-max)	(2, 15)
Duration scope in-out (min)
Mean (SD)	5.6 (4.3)
Median (Q1-Q3)	4.5 (2.2, 9.5)
Range (min-max)	(1, 15)

5ARI: 5-alpha reductase inhibitor; IQR: interquartile range.

Urinary status

At baseline, IPSS was 24.3 ± 5.9, which significantly decreased to 10.5 ± 5.8 at 6 months. By 12 months the reduction was maintained at 11.6 ± 5.4, representing an overall 52.7% improvement from baseline (p = 0.009; Figure 1(a)). Similarly, the IPSS QoL score improved from 4.8 ± 0.9 at baseline to 2 ± 1.5 at 6 months and 2.4 ± 1.7 at 12 months (p = 0.008; Figure 1(b)). The mean peak urinary flow rate (Qmax) increased from 7.9 ± 4.5 mL/s at baseline to 17.8 ± 6.1 mL/s at 12 months (Figure 2(a)). PVR, which was initially 197.6 ± 270.2 mL, reduced to 22.5 ± 26.3 mL at 6 months, to 51 ± 77 mL at 12 months (Figure 2(b)). All patients had their Foley catheter removed within 7 days, with no cases of urinary retention observed.

Figure 1.

(a) IPSS and (b) IPSS QoL scores (95% CI) over time.

Figure 2.

(a) Qmax and (b) PVR values (95% CI) over time.

Sexual function

The International Index of Erectile Function (IIEF) score at baseline was 43.1 ± 25.7. By 6 months, it decreased to 30.3 ± 20.5, and at 12 months, it increased to 35.7 ± 23.2 (Figure 3). No significant differences were observed. Retrograde ejaculation occurred in only one patient (7.1%); all other patients reported no significant change in ejaculatory function.

Figure 3.

IIEF-15 scores (95% CI) over time.

Changes in outcomes from baseline to 3-, 6- and 12-months follow-up are shown in Table 2.

Table 2.

Changes in outcomes from baseline to 3-, 6- and 12-months follow-up.

	Measure	Baseline	M03	M06	M12
PVR	n	12	4	4	9
	Baseline	197.6 ± 270.2	42.5 ± 40.3	42.5 ± 40.3	114.2 ± 158
	Follow up		15 ± 30	22.5 ± 26.3	51 ± 77.1
	Change		−27.5 ± 25	−20 ± 36.5	−63.2 ± 176.4
	% Change		−64.7	−47.1	−55.4
	p Value		0.181	0.423	0.441
QMax	n	13	5	4	7
	Baseline	7.9 ± 4.5	6.2 ± 1.5	5.8 ± 1.3	9 ± 5.7
	Follow up		11.6 ± 2.7	15.3 ± 5.7	17.8 ± 6.1
	Change		5.4 ± 2.9	9.6 ± 4.5	8.8 ± 7.6
	% Change		86.5	166.1	97.9
	p Value		0.058	0.125	0.034
IPSS	n	13	9	8	9
	Baseline	24.3 ± 5.9	24.4 ± 6.7	23.4 ± 6.3	24.4 ± 6.7
	Follow up		13.1 ± 4.4	10.5 ± 5.8	11.6 ± 5.4
	Change		−11.3 ± 7.1	−12.9 ± 9.1	−12.9 ± 9.2
	% Change		−46.4	−55.1	−52.7
	p Value		0.009	0.014	0.009
IPSS QoL	n	13	9	8	9
	Baseline	4.8 ± 0.9	4.8 ± 1	4.8 ± 1	4.8 ± 1
	Follow up		3.1 ± 1.3	2 ± 1.5	2.4 ± 1.7
	Change		−1.7 ± 1.3	−2.8 ± 1.8	−2.3 ± 1.7
	% Change		−34.9	−57.9	−48.8
	p Value		0.021	0.021	0.008
IIEF	n	13	7	6	7
	Baseline	43.1 ± 25.7	28 ± 20.2	27 ± 21.6	33 ± 25.3
	Follow up		28.4 ± 19.7	30.3 ± 20.5	35.7 ± 23.2
	Change		0.4 ± 2.2	3.3 ± 7	2.7 ± 6.4
	% Change		1.5	12.3	8.2
	p Value		1	0.343	0.345

BPHII: Benign Prostatic Hyperplasia Impact Index; IIEF-15: International Index of Erectile Function; IPSS: International Prostate Symptom Score; PVR: post-void residual volume; Qmax: peak urinary flow; QoL: quality of life; SD: standard deviation.

Discussion

Benign prostatic hyperplasia remains a condition that is not yet fully understood. Although lifestyle and metabolic factors are believed to contribute to its development, its pathophysiology continues to evolve, with an increasing recognition of its occurrence in younger men. ¹² Water Vapor Thermal Therapy has established a strong role among minimally invasive surgical treatments (MIST) for BPH, owing to its durable outcomes, significant improvements in urinary function, and minimal impact on sexual function. ¹³ As such, it is particularly appealing to younger men affected by benign prostatic obstruction. Moreover, studies have confirmed that the efficacy of the procedure remains consistent regardless of patient age.^14,15

Over a 12-month follow-up period, our patients demonstrated statistically and clinically significant improvements in symptom scores and clinical parameters. The International Prostate Symptom Score (IPSS) improved by 52.7%, and the IPSS quality of life (QoL) component improved by 48.8%. Similarly, a multicenter randomized sham-controlled trial of Water Vapor Thermal Therapy reported comparable outcomes at 5 years, with a 48% reduction in IPSS, a 45% improvement in QoL, and a 44% increase in maximum urinary flow rate (Qmax). ⁸

In a recent single-center retrospective study, Qmax improved by 4.8 mL/s, accompanied by a significant 50% reduction in mean post-void residual (PVR) volume. In our study, objective clinical measures demonstrated a 97.9% increase in peak urinary flow rate (Qmax) and a 55.4% reduction in PVR. These findings support the clinical efficacy of Rezūm therapy in relieving lower urinary tract symptoms (LUTS). ¹⁶

An important aspect of our study is the preservation of sexual function. In younger men, concerns about sexual side effects often influence treatment choices, as many BPH therapies are linked to adverse sexual outcomes.^8,17 In our cohort, International Index of Erectile Function (IIEF) scores remained stable throughout the follow-up period, indicating that Rezūm therapy does not impair erectile function. This is consistent with previous studies reporting a low risk of sexual dysfunction with Rezūm, supporting its suitability for younger patients who may be reluctant to undergo invasive surgery or long-term pharmacotherapy due to potential sexual side effects.

A recent prospective multicenter study by Minore et al. specifically evaluated Rezūm outcomes in men under 50, enrolling 10 patients across five institutions. The authors reported significant improvements in IPSS, Qmax, and PVR as early as 3 months post-treatment, with stable results maintained through 12 months. Notably, all patients preserved or regained antegrade ejaculation, and no major complications were observed. These findings reinforce our results, demonstrating that Rezūm is both safe and effective in younger men, with favorable outcomes in urinary function and sexual health. Our study adds to this growing body of evidence by including a larger cohort and further supporting the use of Rezūm as a first line minimally invasive surgical therapy (MIST) in appropriately selected younger patients. ¹⁸

Many urologists remain cautious about recommending more invasive surgical interventions for younger men due to the potential for complications, impact on sexual function, and the likelihood of requiring future procedures. ¹⁹ Prolonged use of oral medications—particularly those that may negatively affect sexual performance—also presents a significant concern for this patient population. Rezūm offers a balanced alternative, providing symptom relief while preserving sexual health, thus addressing a critical need in this demographic.

Despite these encouraging results, our study has several limitations. The small sample size and relatively short follow-up period (12 months) limit the generalizability of our findings and do not allow for long-term assessments of durability. Additionally, the absence of a direct comparator group—such as patients treated with standard transurethral resection of the prostate (TURP) or other minimally invasive therapies. Future studies with larger cohorts, extended follow-up, and comparative designs will be essential to validate these results and further clarify Rezūm’s role in the management of BPH, especially among younger patients.

In addition, further research should explore potential predictors of success, patient selection criteria, and the impact of Rezūm therapy on other quality-of-life measures. Given the favorable safety profile and minimal impact on sexual function observed in our study, Rezūm therapy could be considered a first-line alternative option for younger men with BPH seeking alternatives to long-term pharmacotherapy or invasive surgical procedures. ²⁰ Furthermore, findings from other centers have demonstrated sustained improvements in ejaculatory function, with up to 98% of patients maintaining antegrade ejaculation following Rezūm therapy. ²¹

Our study specifically evaluates the outcomes of Rezūm Water Vapor Thermal Therapy in younger men with BPH. Rezūm appears to be a safe and effective treatment option for patients aged 50 years and younger, providing consistent improvements in urinary function while preserving erectile function. As such, it offers a compelling minimally invasive alternative for those experiencing bladder outlet obstruction due to BPH, especially in a population where maintaining sexual function is a central concern.