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. 2025 Jul 29;19(6):396–400. doi: 10.1097/CU9.0000000000000295

Patients with frailty, benign prostatic hyperplasia and indwelling bladder catheter: What are the 1-year outcomes after Rezūm therapy?

Raffaele Balsamo a, Simone Tammaro b,∗, Ferdinando Fusco b, Biagio Barone c, Felice Crocetto d, Celeste Manfredi b, Davide Arcaniolo b, Lorenzo Spirito b, Luca Cindolo e, Marco De Sio b, Francesco Uricchio a
PMCID: PMC12499839  PMID: 41058769

Abstract

Background

Rezūm therapy, a minimally invasive surgical procedure for benign prostatic hyperplasia (BPH), was very recently developed. Its characteristics and safety profile render its use in patients with multiple comorbidities attractive. In this study, we evaluated the outcomes of Rezūm therapy in patients with frailty, BPH, and an indwelling catheter.

Methods

This single-center prospective study involved consecutive patients with frailty who underwent Rezūm therapy from June 2022 to December 2023. Patients with a prostate volume of 30–150 cm3, indwelling bladder catheter for ≥6 months, and diagnosis of frailty were included. Frailty was defined as the concomitant presence of a Clinical Frailty Score of ≥4, Charlson Comorbidity Index of ≥3, and Modified Frailty Index of ≥2. The primary end point was successful removal of the catheter and continued catheter independence 12 months after treatment. The International Prostate Symptom Score, maximum urinary flow rate, and post-void residual volume were evaluated 3, 6, and 12 months after the procedure. Adverse events were monitored throughout the study.

Results

Seventy patients were included: catheter removal was successful in 66 of these patients (94%), all of whom completed 1 year of follow-up without recatheterization. Statistically significant (p < 0.05) improvement was observed in the International Prostate Symptom Score, maximum urinary flow rate, and post-void residual volume during follow-up. No intraprocedural complications occurred. At 30 days, 4 of the 66 patients (6%) experienced postprocedural complications of Clavien-Dindo grades II (n = 2) and IIIa (n = 1).

Conclusions

Rezūm therapy was effectively and safely performed in patients with frailty, BPH, and an indwelling catheter. Further large comparative studies are needed.

Keywords: Benign prostatic hyperplasia, Catheter, Frailty, Rezūm therapy, Water vapor

1. Introduction

Human life expectancy has increased in recent decades due to improved social and economic conditions. Consequently, the global population of older adults has significantly grown. Advanced age is often associated with multiple comorbidities,[1] and older individuals with multiple comorbidities are typically considered frail. Frailty is a clinical condition characterized by an increased susceptibility to adverse health outcomes such as disability, hospitalization, institutionalization, and mortality in response to endogenous or exogenous stressors.[2–4] Notably, the concept of frailty is not exclusively age dependent.[4] The demographic shift has led to a growing demand for medical care services for older patients with frailty, a population for whom the application of standard decision-making algorithms and evidence-based medicine is often challenging.[1]

From an epidemiological perspective, older patients with frailty frequently present with lower urinary tract symptoms related to benign prostatic hyperplasia (BPH). A potential complication of BPH is acute urinary retention.[5] The management of acute urinary retention involves bladder catheterization, followed by medical therapy and a trial without catheter (TWOC).[6–8] For patients who fail multiple TWOCs, surgery remains the treatment of choice for BPH.[9,10] In these cases, the use of an indwelling catheter is required until the surgery is performed.[11]

For decades, transurethral resection of the prostate has been the gold-standard surgical procedure for BPH. Recently, several minimally invasive surgical therapies have been developed to treat BPH-related lower urinary tract symptoms, aiming to reduce surgical morbidity while maintaining an efficacy that is comparable to that of transurethral resection of the prostate.[12–15] One of the most recently developed of these therapies is water vapor thermal therapy (Rezūm System; Boston Scientific Corporation, Marlborough, MA), which uses thermal energy generated by radiofrequency to ablate obstructive prostatic tissue. This procedure has demonstrated efficacy and safety in patients with BPH, including those with an indwelling catheter, and can be performed under sedation in an outpatient setting.[16,17] Recent studies have also shown the effectiveness and safety of the Rezūm System in patients with large prostate volumes of ≥80 mL.[18] Therefore, Rezūm therapy seems to be a suitable and promising surgical option for men with BPH and indwelling catheters who are living with frailty; however, evidence in this specific patient population remains limited.[19–21]

The primary aim of this study was to evaluate the potential role of Rezūm therapy in patients with frailty and an indwelling bladder catheter.

2. Methods

2.1. Study design and ethical details

We conducted a single-center prospective study. Consecutive patients with frailty undergoing Rezūm therapy at our institution—Monaldi Hospital, Naples, Italy—from June 2022 to December 2023 were recruited. This study was conducted in accordance with the Declaration of Helsinki on ethical principles for medical research involving human subjects.[22] The study protocol was approved by the Institutional Review Board (approval number 11566/2022). All patients provided written informed consent for the inclusion of their data in the database and the use of these data in scientific research. Counseling regarding the Rezūm procedure was provided to all participants before the procedure was performed.

2.2. Patient enrollment

The inclusion criteria were a prostate volume of 30–150 cm3, an indwelling bladder catheter for ≥6 months, and a diagnosis of frailty. The prostate volume was measured via transrectal ultrasound. All patients had a history of acute urinary retention and had failed at least 2 TWOCs, despite receiving appropriate medical therapy for BPH. Before undergoing Rezūm therapy, each patient had undergone 2 TWOCs, both of which were unsuccessful. A trial without catheter failure was defined as an inability to achieve spontaneous micturition or a post-void residual (PVR) volume of ≥300 mL.[23] All instances of a PVR volume of ≥300 mL were classified as failures and were excluded from the data collection.

Frailty was defined as the concomitant presence of a Clinical Frailty Score of ≥4, a Charlson Comorbidity Index of ≥3, and a 5-item Modified Frailty Index of ≥2.[24–26]

The exclusion criteria included prior prostate surgery, neurogenic bladder, history of neurological disease, prostate cancer, bladder cancer, pelvic radiotherapy, interstitial cystitis, urethral stricture, chronic prostatitis, bladder stones, bladder diverticula, recurrent catheter-associated urinary tract infections, urinary incontinence, and an International Prostate Symptom Score (IPSS) indicating predominant voiding symptoms (voiding/storage IPSS subscores of >1). Patients with missing data were excluded. The presence of a median prostatic lobe was not used as an exclusion criterion.

2.3. Patient evaluation

Baseline data were collected for age, body mass index, digital rectal examination, prostate-specific antigen levels, prostate measurements, and duration of catheterization. All participants were previously sexually active with antegrade ejaculation, but ceased sexual activity after indwelling catheter placement. Because of catheter dependency, baseline urinary and sexual functions were not assessed, as they were assumed to be severely compromised.

The primary end point was a successful TWOC after the procedure, with sustained catheter independence at 12 months. Secondary outcomes included the IPSS,[27] 5-item version of the International Index of Erectile Function score,[28] peak urinary flow rate (Qmax), and PVR volume, assessed at 3, 6, and 12 months after the procedure was performed. The Patient Global Impression of Improvement (PGI-I) questionnaire was administered at the end of the follow-up period.[29]

Total (from sedation induction to catheterization) and actual (from Rezūm device insertion to removal) procedural times and the number of vapor injections used were recorded. Adverse events were monitored, including intraprocedural and postprocedural complications classified using the Clavien-Dindo classification, urinary incontinence, and anejaculation rates at 12 months.[30] The need for BPH medication after the procedure and surgical retreatments at 12 months was documented.

2.4. Procedural technique and patient management

The Rezūm system consists of a generator with a radiofrequency power supply and a disposable transurethral delivery device compatible with a 4-mm, 30-degree, 30-cm rigid cystoscope lens. Thermal energy is generated via radiofrequency being applied to an inductive coil heater in the handle of the device. This energy is delivered to the prostate through a retractable 8-gauge needle in 9-second injections, as previously described.[31]

All procedures were performed by a single expert surgeon in an outpatient setting under conscious sedation. A Ch 20 Foley catheter was placed after the procedure was performed. If complications were absent, patients were discharged on the same day, after a short observation period, with a bladder catheter.

The first TWOC was scheduled to take place 3 weeks after the procedure. If unsuccessful, up to 2 additional TWOCs were planned at 2-week intervals. Benign prostatic hyperplasia medications were discontinued on the day of the procedure, but were reinstated temporarily in cases of initial TWOC failure. The Rezūm procedure was considered unsuccessful if 3 TWOCs failed or if the catheter needed to be repositioned during follow-up.

2.5. Statistics

The Shapiro-Wilk test[32] was applied to test normality. Continuous variables are reported as medians and interquartile ranges (IQRs), whereas categorical variables are expressed as absolute and relative frequencies. Outcome comparisons at different follow-up time points (3 vs. 6 months and 6 vs. 12 months) were conducted using the Wilcoxon signed-rank test.[33] Subgroup analyses were performed using the Wilcoxon rank sum and Fisher exact tests. A p value of <0.05 was considered the threshold for statistical significance. R Studio v 2024.09.0+375 was used for statistical analyses (Posit, Boston, MA).

3. Results

A total of 70 men with indwelling catheters who were living with frailty were included. Baseline patient characteristics are summarized in Table 1. The median (IQR) age was 75 (72–80) years. The median (IQR) preprocedural prostate volume (PV) was 70 (58–98) cm3, with 31 patients (44%) presenting with a large gland volume (≥80 mL). Overall, 64 patients (92%) presented with a median lobe, and 18 (26%) had an intravesical prostatic protrusion of ≥5 mm. The median (IQR) total and actual procedural times were 12 (9.2–15.8) and 2 (1.7–3.1) minutes, respectively. The median (IQR) number of vapor injections was 8 (6–9.5). No intraprocedural complications occurred.

Table 1.

Baseline characteristics of patients with frailty.

Characteristic Value
Age, yr, median (IQR) 75 (72–80)
Body mass index, kg/m2, median (IQR) 25 (24–27)
mFI-5, median (IQR) 3 (2–5)
Charlson Comorbidity Index, median (IQR) 4 (3–8)
Clinical Frailty Score, median (IQR) 5 (4–9)
Duration of catheterization, mo, median (IQR) 10 (8–14)
PSA level, ng/mL, median (IQR) 3.0 (2.0–4.2)
Prostate volume, mL, median (IQR) 70 (58–98)
Median lobe, n (%) 64 (92)
Preprocedural IPP, n (%)
 No 6 (8)
 Grade I 47 (68)
 Grade II 11 (16)
 Grade III 6 (8)
Open in a new tab

IPP = intravesical prostatic protrusion; IQR = interquartile range; mFI-5 = 5-item Modified Frailty Index; PSA = prostatic-specific antigen.

In 66 men (94%), the catheters were successfully removed 3 weeks after undergoing the procedure. All patients who achieved independence from having to use a catheter completed a 1-year period of follow-up without requiring recatheterization. Four men (6%) failed the initial TWOC and, after 2 additional unsuccessful attempts, were scheduled for surgical retreatment (transurethral resection of the prostate). Among the patients who gained catheter independence, significant improvements were observed in the median IPSS-total score, Qmax, and PVR volume at both 3 versus 6 months and 6 versus 12 months (p = 0.023 and p < 0.001, respectively). After the procedure, the median 5-item version of the International Index of Erectile Function score showed a statistically significant improvement at 3 versus 6 months (p = 0.002) and 6 versus 12 months (p < 0.001). At 12 months, of the 66 men who achieved independence from catheter use, 51 (77%) regained antegrade ejaculation and resumed sexual activity. The postprocedural outcomes of the patients who were catheter independent are summarized in Table 2. At 12 months, all men who were catheter independent reported an improvement on the PGI-I questionnaire, with 54 (81%) describing their condition as “much better” or “very much better.”

Table 2.

Outcomes of patients with frailty who achieved catheter independence.

Outcome, median (IQR) 3 mo 6 mo p 6 mo 12 mo p
Qmax, mL/s 12 (11–15) 14 (12–17) <0.001 14 (12–17) 16 (13–19) <0.001
PVR volume, mL 50 (30–70) 45 (30–60) 0.023 45 (30–60) 40 (30–55) <0.001
IPSS-total 20 (16–23.8) 17 (15–20) <0.001 17 (15–20) 15 (13–19) <0.001
IPSS-storage 10 (8–12) 9 (7–10) <0.001 9 (7–10) 8 (7–10) <0.001
IPSS-voiding 10 (7–10) 8 (6–9) <0.001 8 (6–9) 7 (5–8) <0.001
IIEF-5 11.5 (5–20) 14 (6–15.8) 0.002 14 (6–15.8) 18.5 (7.5–21.25) <0.001
Open in a new tab

Statistically significant p values are presented in bold.

IIEF-5 = 5-item version of the International Index of Erectile Function; IPSS = International Prostate Symptom Score; IQR = interquartile range; PVR = post-void residual; Qmax = peak flow rate.

Before undergoing Rezūm therapy and because of having indwelling catheters placed, none of the patients were being administered medication for BPH. Only 3 men resumed pharmacological therapy after an unsuccessful TWOC. The remaining patients who were catheter independent did not require any medication during the 12 months of follow-up.

Within the first 30 days after undergoing the procedure, 4 of the 66 patients (6%) experienced complications: 2 patients had prostatitis and required antibiotic therapy (Clavien-Dindo grade II), and 1 patient developed a fibrin clot that necessitated endoscopic removal (Clavien-Dindo grade IIIa). At 12 months, 6 of the 66 patients (8.5%) reported mild postprocedural urgency urinary incontinence (0–1 pad/day), and the anejaculation rate was 23.4% (15/66 patients). No statistically significant differences in efficacy or safety outcomes were identified when the cohort was stratified by PV (≤80 vs. >80 cm3) or by the duration of catheterization before surgery (≤12 vs. >12 months).

4. Discussion

Several minimally invasive surgical treatments have been proposed as alternatives to conventional surgical interventions for BPH. The aim of using these novel procedures is to minimize both surgical and sexual morbidity while maintaining comparable efficacy.[34,35] Reducing surgical morbidity is particularly relevant in high-risk populations, such as those of older patients.[36,37]

Rezūm therapy has emerged as a promising minimally invasive surgical therapy. Although previous studies have evaluated its efficacy and safety in older patients with catheters,[11,38–41] few have specifically assessed its outcomes in individuals living with frailty who were dependent on catheter use.

In an observational study, Eredics et al.[42] reported a high success rate of water vapor therapy in 136 patients with recurrent urinary retention and indwelling catheters. The mean patient age was 80.3 (range, 59–97) years, compared with 75 (IQR, 72–80) years in our cohort. Both studies included patients deemed unsuitable or at high risk for surgery under general anesthesia due to multimorbidity and or frailty. The mean PV in the study by Eredics et al. was 54 mL, compared with 70 (IQR, 58–98) mL in our study, with a similar duration of catheter dependency (4.8 vs. 6 months). Their study reported a spontaneous voiding rate of 78.6% and a catheter independence rate exceeding 90% at ≥12 months. These outcomes align closely with our findings: 94% of patients maintained their status of catheter independence with spontaneous voiding at 1 year. Furthermore, 81% of the men in our cohort who were catheter-independent reported significant improvement on the PGI-I questionnaire.

Similarly, Tadrist et al.[43] described their experience using the Rezūm™ system to remove the need for indwelling catheters in patient with frailty and multimorbidity. They reported a 100% voiding success rate (22/24 patients) after a median postoperative catheterization period of 21 days, with no recurrences at 1 year. These findings are comparable to those of our study, despite differences in sample size and frailty assessment.

Our results demonstrate that 94% of men who were catheterized and living with frailty and treated with Rezūm therapy achieved spontaneous voiding, with sustained improvement in urinary function (measured using the IPSS, Qmax, and PVR volume) at 1 year. The low rate of postoperative complications (approximately 6%) underscores the favorable safety profile of Rezūm therapy in this population of individuals who are at high risk.

This study is among the first to specifically evaluate Rezūm therapy in patients with frailty who also have catheters. The study's strengths include its prospective design and the use of validated assessment tools. However, several limitations must be acknowledged. The primary limitations include the small sample size and the lack of a control group. Moreover, the absence of a standardized and widely accepted definition of frailty and TWOC failure may impact the generalizability of the findings. Certain parameters, such as the PVR volume, may have been influenced by the sample size. The relatively short period of follow-up and the single-surgeon series design represent additional limitations. Lastly, the presence of an indwelling catheter before treatment precluded an objective baseline evaluation of urinary function, preventing direct preprocedural and postprocedural comparisons. Nevertheless, removal of the catheter and restoration of spontaneous voiding should be considered significant indicators of improvement in urinary function.

Rezūm therapy induces delayed tissue ablation, necessitating more than 3 months for full resorption and reduction of the PV. Therefore, in cases of initial TWOC failure, up to 3 TWOC attempts may be warranted.[19,42–45] Further large-scale comparative studies are required to validate our findings and refine treatment recommendations.

5. Conclusions

Rezūm therapy provided an effective and safe intervention for patients with frailty, BPH, and indwelling catheters, offering a high likelihood of catheter removal with minimal severe complications. Further large-scale studies are needed to confirm these promising results and establish definitive clinical guidelines.

Acknowledgments

We acknowledge Dr. M. Campanaro for her invaluable assistance in revising the manuscript.

Statement of ethics

This study was conducted in accordance with the Declaration of Helsinki on ethical principles for medical research involving human subjects. The study protocol was approved by the Institutional Review Board of University of Campania “Luigi Vanvitelli” - AOU Luigi Vanvitelli - AORN “Ospedali dei Colli” (approval number 11566/2022). All patients provided written informed consent for the inclusion of their data in the database and the use of these data in scientific research.

Conflicts of interest statement

All authors have completed the ICMJE uniform disclosure form. The authors have no conflicts of interest to declare.

Funding source

None.

Author contributions

ST, RB: Conception and design;

MDS, FF, FU, FC, MF: Administrative support;

RB, FU, DA: Provision of study materials or patients;

ST, BB, CM, LS: Collection and assembly of data;

BB, CM, ST: Data analysis and interpretation;

All authors: Manuscript writing and final approval of manuscript.

Data availability

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

Footnotes

How to cite this article: Balsamo R, Tammaro S, Fusco F, Barone B, Crocetto F, Manfredi C, Arcaniolo D, Spirito L, Cindolo L, De Sio M, Uricchio F. Patients with frailty, benign prostatic hyperplasia and indwelling bladder catheter: what are the 1-year outcomes after rezūm therapy?. Curr Urol 2025;19(6):396–400. doi: 10.1097/CU9.0000000000000295

Contributor Information

Raffaele Balsamo, Email: raffaelebalsamo5@gmail.com.

Simone Tammaro, Email: simone.tammaro95@gmail.com.

Ferdinando Fusco, Email: ferdinando-fusco@libero.it.

Biagio Barone, Email: biagio193@gmail.com.

Felice Crocetto, Email: felice.crocetto@unina.it.

Celeste Manfredi, Email: manfredi.celeste@gmail.com.

Davide Arcaniolo, Email: davide.arcaniolo@gmail.com.

Lorenzo Spirito, Email: lorenzospirito@msn.com.

Luca Cindolo, Email: lucacindolo@gmail.com.

Marco De Sio, Email: desiomd@gmail.com.

Francesco Uricchio, Email: francesco.uricchio@ospedalideicolli.it.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

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

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