ABSTRACT
Background and Aims
Benign prostatic hyperplasia (BPH) is among the most common urologic conditions in elderly men, presenting with lower urinary tract symptoms. Prostatic artery embolization (PAE) is a recent interventional treatment for BPH.
Methods
This prospective single‐center study reviewed the results of cases that underwent PAE for BPH from 2020 to 2022. Inclusion criteria were men with BPH refractory to pharmacologic treatment or those experiencing persistent adverse effects from medications, who were not candidates for surgical management. Assessments were made using ultrasonography for prostate volume and the International Prostate Symptom Score (IPSS) before and at 3 and 12 months after PAE. The clinical success rate of PAE was assessed according to the Cardiovascular and Interventional Radiological Society of Europe Standards of Practice. Recurrence of symptoms and complications after PAE were also recorded.
Results
From a total of 46 included patients, clinical success was achieved in 93% at 3 months and 85% at 12 months. Complications occurred in eight (17.4%) cases, including five cases of erectile dysfunction and three cases of urinary tract infection. Eight (17.4%) cases had recurrent symptoms and required pharmacologic treatment, while seven (15.2%) needed surgery. The IPSS score dropped significantly at 3 months, with a mean difference of −16.2 (95% CI: −17.7 to −14.8) (p < 0.001), and at 12 months after PAE, with a mean difference of −13.5 (95% CI: −15.9 to −11.1) (p < 0.001). Prostate volume decreased significantly at 3 months, with a mean difference of −36.0 (95% CI: −43.0 to −29.0) (p < 0.001), and at 12 months, with a mean difference of −37.3 (95% CI: −43.7 to −31.0) (p < 0.001).
Conclusion
The findings of this study indicate that PAE is an effective therapeutic approach for patients with BPH, demonstrated by the low rates of adverse events and the absence of major complications.
Keywords: benign prostate hyperplasia, complication, interventional radiology, outcome, prostate artery embolization
1. Introduction
Benign prostatic hyperplasia (BPH) is one of the most common urologic diseases affecting elderly men, characterized by obstructive and other lower urinary tract symptoms (LUTS) [1]. Histologic changes and growth in the transition zone of the prostate, which constitutes about 5% of the gland and surrounds the proximal urethra, lead to LUTS. These symptoms include frequency, urgency, dysuria, incomplete bladder emptying, and a weak urination stream [2]. Globally, the prevalence of BPH has been estimated at approximately 2500 cases per 100,000 population, with the disease burden increasing over the past years, especially in low‐ and middle‐income countries [3]. It is estimated that among men aged over 50, 50–75% experience BPH‐induced LUTS, with this percentage rising significantly with age. For instance, among men aged over 70, about 80% are affected [1].
Diagnosis of BPH is made through a combination of clinical assessments, including history and physical examination, particularly digital rectal examination, and paraclinical methods involving laboratory tests and imaging tools [4]. Uroflowmetry is another key guideline‐recommended tool for assessing benign prostatic obstruction and aids in managing LUTS and BPH [5]. Ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) are key radiologic tools used to evaluate prostate size and plan treatment approaches, as well as to help differentiate BPH from malignant prostatic lesions [6]. Before any radiologic evaluation, a comprehensive assessment of the patient's symptoms is essential, and the International Prostate Symptom Score (IPSS) is a valuable tool for assessing the severity of LUTS during both diagnosis and follow‐up stages of the disease [7, 8].
Treatment options for BPH range from pharmacologic therapies to surgical interventions such as transurethral resection of the prostate (TURP) for cases resistant to medical treatment or exhibiting progressing symptoms [2, 9, 10]. Prostatic artery embolization (PAE) has emerged as a nonsurgical intervention with growing interest among clinicians over the past decade, showing promising results [11, 12]. Several studies have reported outcomes of PAE in different populations; however, results regarding the efficacy and safety of this approach vary [13, 14, 15, 16, 17, 18, 19, 20, 21]. There are ongoing debates comparing PAE to standard surgical approaches like TURP, necessitating further examination to establish its efficacy and safety [22, 23, 24, 25].
This study aims to assess the outcomes of PAE in a series of cases in Iran, focusing on patients who failed medical treatment and were followed for 1 year to monitor symptoms and PAE outcomes. The scarcity of data on this intervention in Iran enhances the relevance of this study, providing valuable evidence for further research and clinical applications in the country.
2. Materials and Methods
2.1. Study Design and Population
We conducted a prospective study at the Advanced Diagnostic and Interventional Radiology Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran, from 2020 to 2022. The study included candidates for PAE who had experienced failure of medical treatment for BPH (IPSS > 7 while on pharmacologic treatment or experiencing drug complications) and were not candidates for surgical treatment and anesthesia due to comorbidities and other contraindications. Exclusion criteria included urologic malignancy, atherosclerosis, tortuosity of the iliac arteries, other pelvic vascular complexities, and candidacy for urologic surgeries such as for renal stones, bladder diverticula, hematuria, history of overactive bladder, and history of pelvic surgery or radiation therapy.
2.2. Embolization Protocol
Eligible patients underwent pelvic CT angiography before the procedure to detect any vascular complexities and to identify the origin of the inferior vesical artery (IVA), the major feeding artery of the prostate. Pelvic angiography was performed through femoral artery access, followed by placement of the catheter at the internal iliac artery. Digital subtraction angiography (DSA) was then used to assess the prostate blood supply and detail the IVA. A microcatheter ranging in size from 1.7 French to 2.4 French was inserted into the IVA lumen and positioned distally before its bifurcation into anteromedial and posterolateral branches. After confirming prostate parenchyma perfusion and ensuring no arterial side branches were at risk of nontarget embolization, embolization was carried out by injecting microspheres measuring 300–500 μm. The target endpoint of embolization was defined as achieving complete occlusion, characterized by slow flow or stasis in the prostatic arteries and disruption of arterial flow, accompanied by clear opacification of the prostate gland.
2.3. Data Collection
Clinical data were collected through interviews and paraclinical assessments at three time points: before PAE, 3 months after PAE, and 12 months after PAE. Interviews primarily focused on symptoms, assessing elements of the IPSS questionnaire. Paraclinical assessments involved ultrasonography to measure prostate volume. Patient follow‐up continued for 1 year to monitor symptoms and complications related to PAE.
2.4. Definition of Variables
Collected demographic and clinical variables included age, body mass index (BMI), Charlson Comorbidity Index (CCI) score, prostate‐specific antigen (PSA) (ng/mL), IPSS score, and International Index of Erectile Function (IIEF‐5) score. The IPSS questionnaire, which assesses seven LUTS—frequency, urgency, nocturia, intermittency, weak stream, straining, and incomplete emptying—on a scale of 0–5, yielding a total score of 0‐35, served as the primary clinical assessment tool. Based on this scoring, patients were categorized as mildly symptomatic (0–7), moderately symptomatic (8–19), or severely symptomatic (20–35) [8]. We used these ranges to categorize recorded IPSS scores to analyze changes before and after PAE. Prostate volume (cm3) measured during ultrasonography was another study variable, categorized as < 50 cm3, 50–80 cm3, and > 80 cm3, based on previous publications [14]. Recurrences of symptoms post‐PAE and the need to resume medical treatment or proceed to surgical intervention were among the outcomes assessed. Erectile dysfunction (ED) was assessed using IIEF‐5 score and categorized into five severity levels of absence of ED (IIEF‐5 score 22–25), mild (score 17–21), mild to moderate (score 12–16), moderate (score 8–11), and severe (score 5–7) ED [26].
2.5. Definition of Intervention Success
We measured the intervention success in two aspects: technical success and clinical success. Technical success was defined as the successful embolization of at least one prostate lobe during the procedure [27]. The clinical success rate of PAE for BPH was determined by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Standards of Practice on PAE [28]. Clinical success was defined as achieving symptomatic improvement, indicated by an IPSS score of less than 18 and a reduction of at least 25% from the baseline score [16].
2.6. Statistical Analysis
Quantitative variables were summarized using mean ± standard deviation, and qualitative variables were summarized by frequency and percentages. We used paired samples t‐tests to examine mean changes in primary study objectives before PAE and at two follow‐up assessments. Mean differences in changes were reported with a 95% confidence interval (95% CI). Paired pre‐ and post‐PAE categorized variables of IPSS and prostate volume were compared using the McNemar–Bowker test via the nominal symmetry test. A two‐tailed p value < 0.05 was set as the significance level for comparisons. Data analysis and visualization were performed using R version 4.4.2 (https://www.R-project.org/).
2.7. Ethical Considerations
This study received ethical approval from the ethical committee at Tehran University of Medical Sciences (code: IR.TUMS.IKHC.REC.1399.500). Also, clinical trial approval for the base intervention was obtained from the Iranian Registry of Clinical Trials (code: IRCT2015100318457N2). All patients provided informed consent before participation in study and were free to leave the study at any stage.
3. Results
3.1. General Findings
A total of 46 patients with BPH were prospectively evaluated and analyzed in this study. The mean age of the included patients was 67.2 ± 6.7 years. At baseline before intervention, patients had a mean BMI of 27.5 ± 2.2, mean CCI score of 2.5 ± 1.2, mean PSA of 6.1 ± 2.3 (ng/mL), mean prostate volume of 93.4 ± 23.4 (cm3), mean IPSS score of 25.3 ± 5.0, and mean IIEF‐5 score of 17.0 ± 2.2 (Table 1).
Table 1.
Patient demographics and baseline characteristics.
| Variable | N = 461 |
|---|---|
| Age, years | |
| Mean (SD) | 67.2 (6.7) |
| Median (Q1, Q3) | 67.0 (61.0, 72.0) |
| BMI | |
| Mean (SD) | 27.5 (2.2) |
| Median (Q1, Q3) | 27.5 (25.9, 29.0) |
| Charlson Comorbidity Index score | |
| Mean (SD) | 2.5 (1.2) |
| Median (Q1, Q3) | 2.0 (2.0, 3.0) |
| Prostate‐specific antigen (PSA), ng/mL | |
| Mean (SD) | 6.1 (2.3) |
| Median (Q1, Q3) | 5.9 (4.1, 8.1) |
| Prostate volume, cm3 | |
| Mean (SD) | 93.4 (23.4) |
| Median (Q1, Q3) | 92.0 (80.0, 101.0) |
| International Prostate Symptom Score (IPSS) score | |
| Mean (SD) | 25.3 (5.0) |
| Median (Q1, Q3) | 26.0 (25.0, 29.0) |
| International Index of Erectile Function (IIEF‐5) score | |
| Mean (SD) | 17.0 (2.2) |
| Median (Q1, Q3) | 17.0 (16.0, 18.0) |
| Sondage | 4 (8.7%) |
Mean (SD), median (Q1, Q3), or frequency (%).
PAE achieved a clinical success rate of 93% at 3 months and 85% at 12 months. Regarding complications, 8 (17.4%) patients experienced complications after PAE: five developed ED and three developed urinary tract infections. Additionally, seven patients (15.2%) underwent TURP after 18 months due to recurrent symptoms, and eight patients (17.4%) experienced recurrent LUTS requiring medical treatment after 12 months. Notably, one patient who had reported pelvic and perineal pain indicative of prostatodynia before PAE experienced complete resolution of pain within the first month after the intervention.
3.2. IPSS Changes
The average IPSS before PAE was 25.4 ± 4.9, which significantly decreased to 9.1 ± 4.1 3 months after PAE, indicating a substantial reduction with a mean difference of −16.2 (95% CI: −17.7 to −14.8) (p < 0.001). By 12 months post‐PAE, the mean IPSS was 11.9 ± 8.4, showing a further significant decrease with a mean difference of −13.5 (95% CI: −15.9 to −11.1) (p < 0.001). Additionally, a comparison of IPSS scores between the three‐ and twelve‐month follow‐ups revealed a significant change, with a mean difference of 2.7 (95% CI: 0.3 to 5.1) (p = 0.0268) (Figures 1 and 2).
Figure 1.
Distribution of IPSS scores over time. Box plot showing the distribution of IPSS scores at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. Comparing the box plots highlights the initial improvement in symptoms at 3 months and the variability at 12 months.
Figure 2.
Mean IPSS score over time. Line plot showing the mean IPSS score at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. Error bars represent the standard deviation, highlighting the significant reduction in the mean IPSS score at 3 months and the partial increase at 12 months.
3.3. IPSS Score Categories
According to the IPSS guidelines, total IPSS scores are categorized into three groups: 0–7 (mildly symptomatic), 8–19 (moderately symptomatic), and 20–35 (severely symptomatic). We analyzed the IPSS scores of patients at three key time points in the study. Before PAE, none of the patients were classified as mildly symptomatic; 3 patients (6.5%) were moderately symptomatic; and the majority, 43 patients (93.5%), were severely symptomatic. At the 3‐month follow‐up post‐PAE, a substantial shift was observed: 18 patients (39.1%) were mildly symptomatic, 28 patients (60.9%) were moderately symptomatic, and none were severely symptomatic. Twelve months post‐PAE, the distribution included 14 patients (30.4%) who were mildly symptomatic, 19 patients (41.3%) who were moderately symptomatic, and 13 patients (28.3%) who returned to being severely symptomatic (Figure 3).
Figure 3.
Proportions of symptom severity categories over time. Bar plot showing the proportions of symptom severity categories at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. Categories are defined as follows: red for severely symptomatic, blue for moderately symptomatic, and green for mildly symptomatic. The plot highlights the significant decrease in the proportion of the severely symptomatic category and the corresponding increase in the moderately symptomatic and mildly symptomatic categories over time.
Statistical analysis of these proportions demonstrated a significant difference in the distribution of IPSS categories from pre‐PAE to the follow‐ups at 3 months (p < 0.001) and 12 months post‐PAE (p < 0.001).
3.4. IPSS Domains
Analysis of IPSS domain changes before and after PAE indicated minor variations but a consistent trend in symptom progression over time. The symptom with the highest score before PAE was a weak stream, averaging 4.4 ± 0.9. This score decreased to 1.5 ± 0.6 3 months after PAE and slightly increased to 1.7 ± 1.1 by the 12‐month evaluation. During the 3‐month follow‐up, the weak stream and straining both scored highest at 1.5 ( ± 0.6 and ± 0.8, respectively), while straining was the most pronounced symptom at 12 months, scoring 2.0 ± 1.6 (Table 2, Figures 4 and 5).
Table 2.
Summary of IPSS domains scores in three time points of study.
| IPSS domains | Before PAE1 | 3 Months after PAE1 | 12 Months after PAE1 |
|---|---|---|---|
| Frequency | 3 (1.4) | 1.2 (0.6) | 1.5 (1) |
| Incomplete emptying | 4.2 (0.7) | 1.1 (0.6) | 1.3 (1) |
| Intermittency | 3.3 (1.3) | 1 (0.7) | 0.9 (0.9) |
| Nocturia | 2.5 (1.2) | 1.2 (0.8) | 1.1 (0.6) |
| Strain | 3.5 (1.2) | 1.5 (0.8) | 2 (1.6) |
| Urgency | 3.6 (0.7) | 0.8 (1) | 1 (1) |
| Weak stream | 4.4 (0.9) | 1.5 (0.6) | 1.7 (1.1) |
Mean (SD).
Figure 4.
Mean IPSS domain scores over time by symptom. Line plot showing the mean IPSS domain scores for different symptoms (frequency, incomplete emptying, intermittency, nocturia, straining, urgency, and weak stream) at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. Error bars represent the standard deviation, indicating the variation in symptom severity reduction at 3 months and changes at 12 months.
Figure 5.
Radar plot of mean IPSS domain scores by symptom over time. Radar plot showing the mean IPSS domain scores for different symptoms (frequency, incomplete emptying, intermittency, nocturia, straining, urgency, and weak stream) at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. The plot illustrates the reduction in symptom severity across different domains post‐PAE and the variability in symptom scores over time.
3.5. Prostate Volume Changes
Initial prostate volume assessments before PAE showed a mean volume of 93.4 ± 23.4 cm3. This reduced significantly to 57.3 ± 15.2 cm3 3 months post‐PAE, representing a mean decrease of −36.0 (95% CI: −43.0 to −29.0) (p < 0.001). By 12 months post‐PAE, the mean prostate volume was 56.0 ± 16.7 cm3, a significant decrease from pre‐PAE values by −37.3 (95% CI: −43.7 to −31.0) (p < 0.001). However, the change in prostate volume from 3 to 12 months post‐PAE was minimal and not statistically significant, with a mean difference of −1.3 (95% CI: −7.8 to 5.2) (p = 0.693) (Figures 6 and 7).
Figure 6.
Distribution of prostate volume over time. Box plot showing the distribution of prostate volume at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. Comparing the plots illustrates the initial reduction in prostate volume at 3 months and the variability at 12 months.
Figure 7.
Mean prostate volume over time. Line plot showing the mean prostate volume at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. Error bars represent the standard deviation, highlighting the significant reduction in mean prostate volume at 3 months and the stabilization at 12 months.
3.6. Prostate Volume Categories
Regarding categorization based on prostate volume, before PAE, 33 patients (71.7%) were categorized as > 80 cm3 and 13 patients (28.3%) as 50–80 cm3, with no patients in the < 50 cm3 category. At the 3‐month follow‐up post‐PAE, the distribution shifted significantly, with 21 patients (45.7%) in each of the < 50 cm3 and 50–80 cm3 categories and 4 patients (8.7%) remaining in the > 80 cm3 category. By the 12‐month follow‐up, 20 patients (43.5%) were in the < 50 cm3 category, 23 patients (50.0%) were in the 50–80 cm3 category, and 3 patients (6.5%) were in the > 80 cm3 category (Figure 8). Paired proportions statistical testing indicated a significant difference in the distribution of prostate volume categories from pre‐PAE to 3 months (p < 0.001) and to 12 months post‐PAE (p < 0.001).
Figure 8.
Proportions of prostate volume categories over time. Bar plot showing the proportions of prostate volume categories at three time points: before PAE, 3 months post‐PAE, and 12 months post‐PAE. Categories are defined as follows: red for > 80, blue for 50–80, and green for < 50. The plot highlights the decrease in the proportion of the > 80 category and the corresponding increase in the 50–80 and < 50 categories over time.
Examples of angiograms before and after PAE are provided in Figure 9.
Figure 9.
Imaging of prostatic artery embolization. (A) Pre‐prostatic artery embolization angiogram of the inferior vesical artery. (B) Post‐prostatic artery embolization angiogram of the inferior vesical artery. (C) Axial T2‐weighted magnetic resonance imaging of the prostate 1 month after embolization, showing a central low T2 signal consistent with central necrosis.
3.7. IIEF‐5 Changes
The mean IIEF‐5 score among the included cases was 17.0 ± 2.2 before PAE, which increased to 19.0 ± 0.9 3 months post‐PAE and further improved to 20.0 ± 0.9 12 months post‐PAE. This upward trend in the mean IIEF‐5 score during the follow‐up period indicates a general improvement in erectile function for most patients. Before PAE, only one patient had a severe ED score below 11 (score of 6). Following treatment, this patient's score remained low, and an additional five patients developed scores in the range of 8–11, indicating moderate ED.
4. Discussion
This study explored the efficacy of PAE in patients with BPH who had not responded to medical treatment and were unsuitable for surgical management. The primary findings demonstrate significant relief of LUTS due to BPH, particularly in the first 3 months post‐intervention. Although some symptoms recurred within the 1‐year follow‐up period, they were generally less severe compared to baseline. Additionally, the low rate of complications post‐PAE underscores the safety of this intervention, suggesting it is a viable treatment option for severe cases of BPH.
Our results align with those from similar studies in the field. Notably, the average IPSS score in our cohort decreased by 16.2 within the first 3 months post‐PAE, compared to a 9.23 decrease reported in another study [29]. Furthermore, prostate volume reduction averaged 36.0 cm3 in our study over 3 months, significantly higher than the 12.17 cm3 reduction observed in the comparative study [29]. A different study with a 7‐month follow‐up reported a prostate volume reduction of 18.2 cm3, equivalent to a 19.2% reduction, and an IPSS decrease of 11.3, representing a 44.8% decrease from baseline [15]. Additional research revealed a 31.6% decrease in prostate volume 1 year post‐PAE, with substantial declines in IPSS both 1 month and 1 year after embolization [16]. A systematic review noted an average IPSS reduction from 24.51 to 10.42 6 months post‐PAE, alongside a mean prostate volume decrease from 96.56 to 46.73 cm3 within 12 months [30]. A meta‐analysis highlighted significant reductions across studies in both IPSS, averaging a 14.81 score decrease, and prostate volume, with an average reduction of 28 cm3 during the pooled follow‐up periods [17]. In a cross‐sectional study of patients with significant urinary obstruction and prostate volumes exceeding 80 cm3, the average IPSS decreased from 23.98 to 10.40 and prostate volume from 129.31 to 71.20 cm3 1 year after PAE, both statistically significant changes [18]. Further research within 6 months post‐PAE showed substantial reductions in IPSS from 27 to 8 and prostate volume from 110 to 67 cm3 [19]. The largest study on PAE outcomes, which involved 255 patients over a period ranging from 1 to 36 months with a mean follow‐up of 10 months, reported cumulative PAE success rates between 81.9% and 72% [31].
Our study demonstrated the peak efficacy of PAE for BPH at 3 months post‐intervention. This aligns with findings from another study that reported the most significant symptom improvements at 3 months compared to 1 and 6 months post‐PAE [13]. Further research stratified patients by baseline prostate volume into categories of less than 50 cm3, 50–80 cm3, and over 80 cm3 and observed the greatest symptom resolution at 3 months across all groups [14]. In our cohort, less than one‐fifth of patients experienced a recurrence of LUTS post‐PAE, which is comparable to another study where the recurrence rate was 13.3%, with cases occurring 6 and 12 months post‐intervention, both of which were successfully managed by TURP [22].
A major strength of our study was the absence of any severe complications, such as ischemic changes in other organs, and a considerably lower rate of minor complications compared to other studies. Complications in our cohort were primarily ED in five cases and urinary tract infections in three cases, which is consistent with a study reporting a 9.8% infection rate post‐PAE requiring antibiotic therapy [15]. A systematic review reported a minor complication rate of 35.6%, which was mostly benign except for one case of bladder ischemia that led to partial bladder resection [30]. Bladder ischemia has also been noted as a rare but serious complication in other studies [11, 31]. A meta‐analysis reported major complication rates of perineal and urethral pain in 9.4% and hematuria in 9% of cases [17]. Another study documented a range of minor complications from 9% to 36%, all resolving within a week post‐PAE, and noted the occurrence of acute urinary retention in about one‐third of cases, requiring Foley catheterization for 3–7 days post‐intervention [19]. In our series, none of the patients required catheterization post‐PAE, nor did any experience urinary retention.
Notably, one case in our study involving severe prostatodynia before PAE showed remarkable improvement, with the pain completely resolving after the embolization. This patient reported no pain during the first year of follow‐up, highlighting the potential of PAE to significantly enhance the quality of life in patients with BPH. This finding is in line with previous reports, such as a study on nine patients with medically recalcitrant radiation‐induced prostatitis that showed similar promising results [32]. However, further research involving a larger cohort is necessary to fully assess PAE's efficacy in this specific scenario.
PAE offers a less invasive alternative to surgical options like TURP, often performed through peripheral vascular access (mainly the femoral artery) using local anesthetics, facilitating outpatient procedures and rapid patient recovery. High success rates ranging from 75% to 94% have been reported in various studies [23]. Notably, most patients do not require Foley catheterization post‐PAE, and medical treatments are often completely ceased in the months following the procedure [16, 23]. Unlike surgical approaches such as TURP, which may present higher complication rates with larger prostate volumes (over 80 cm3), PAE does not have a prostate volume limitation and has been demonstrated to be safe even in larger prostates, with a low risk of major complications [10, 21]. Moreover, PAE is effective and safe in older patients, showing comparable results across different age groups with no age‐related limitations for the intervention [20].
A systematic review and meta‐analysis comparing PAE to surgical approaches for treating LUTS induced by BPH indicated that PAE might be superior in terms of short‐term outcomes, particularly concerning lower rates of major and sexual complications. However, surgical approaches might be more reliable and successful in midterm and long‐term evaluations [25]. The most recent systematic reviews and data synthesis of studies pooling results of PAE and comparing the results of this minimally invasive procedure to surgical interventions like TURP highlight the comparable efficacy of PAE in reducing moderate to severe LUTS in BPH cases who are not eligible for surgery and have failed the medical therapies leading to notable improvements in urological symptoms and patient quality of life with a low risk of complications and only a few adverse events [33, 34, 35]. The paramount success of PAE in control of BPH symptoms has also been reflected in recently updated American Urological Association Guidelines for the management of BPH, which brings more attention to this procedure as a viable option [36, 37].
Given the limited evidence currently available on the use of PAE for BPH treatment across different populations, there is a recommendation for expanded research and clinical evaluation [10, 23]. Further studies also suggest enhancing PAE outcomes in BPH management through precise candidate selection, especially for those with severe obstructive symptoms, and meticulous embolization coupled with a thorough understanding of the pelvic vascular map [38, 39]. Collectively, PAE presents a viable alternative to surgical interventions for managing severe and refractory BPH, especially in patients with comorbidities that are prevalent in this demographic.
This study faced several limitations, including a relatively intermediate number of participants and the absence of a control group receiving surgical treatments such as TURP. The limited follow‐up period of 1 year also constrains the long‐term assessment of PAE's effectiveness. Despite these limitations, this study is notable for being the first to report on the outcomes of PAE for BPH in Iran, providing robust analytical results. These findings offer valuable insights for researchers and expand the knowledge base for the further application of this minimally invasive therapeutic approach.
5. Conclusions
PAE is a safe and effective therapeutic approach for patients with BPH, with the maximum efficacy observed within the first 3 months postprocedure. Given the low rates of adverse events and absence of major complications following PAE, this intervention represents a safe option for treating LUTS in patients with BPH.
Author Contributions
Sina Delazar: conceptualization, data curation, investigation, methodology, project administration, writing – original draft, writing – review and editing, validation. Sina Azadnajafabad: conceptualization, data curation, methodology, investigation, validation, formal analysis, software, visualization, writing – original draft, writing – review and editing. Kavous Firouznia: methodology, investigation, validation, resources, writing – review and editing. Mohammad Reza Nowroozi: methodology, investigation, validation, writing – review and editing. Erfan Amini: conceptualization, investigation, methodology, writing – review and editing, validation. Maryam Fotouhi: methodology, investigation, writing – review and editing. Hossein Ghanaati: conceptualization, investigation, methodology, project administration, supervision, writing – review and editing.
Ethics Statement
This study received the ethical approval from the ethical committee at Tehran University of Medical Sciences (code: IR.TUMS.IKHC.REC.1399.500). Also, the clinical trial approval for the base intervention was obtained from the Iranian Registry of Clinical Trials (code: IRCT2015100318457N2). All patients provided informed consent before participation in study and were free to leave study in any stage.
Conflicts of Interest
The authors declare no conflicts of interest.
1. Transparency Statement
The lead author Hossein Ghanaati affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Acknowledgments
The authors would like to thank all the patients who participated in this study and those who supported this survey.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
References
- 1. Egan K. B., “The Epidemiology of Benign Prostatic Hyperplasia Associated With Lower Urinary Tract Symptoms,” Urologic Clinics of North America 43, no. 3 (2016): 289–297. [DOI] [PubMed] [Google Scholar]
- 2. Lokeshwar S. D., Harper B. T., Webb E., et al., “Epidemiology and Treatment Modalities for the Management of Benign Prostatic Hyperplasia,” Translational Andrology and Urology 8, no. 5 (2019): 529–539. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3. Awedew A. F., Han H., Abbasi B., Collaborators GBDBPH , et al., “The Global, Regional, and National Burden of Benign Prostatic Hyperplasia in 204 Countries and Territories From 2000 to 2019: A Systematic Analysis for the Global Burden of Disease Study 2019,” Lancet Healthy Longevity 3, no. 11 (2022): e754–e776. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4. Nickel J. C., Méndez‐Probst C. E., Whelan T. F., Paterson R. F., and Razvi H., “2010 Update: Guidelines for the Management of Benign Prostatic Hyperplasia,” Canadian Urological Association 4, no. 5 (2010): 310–316. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5. Pandolfo S. D., Crauso F., Aveta A., et al., “A Novel Low‐Cost Uroflowmetry for Patient Telemonitoring,” International Journal of Environmental Research and Public Health 20, no. 4 (2023): 3287. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6. Grossfeld G. D. and Coakley F. V., “Benign Prostatic Hyperplasia: Clinical Overview and Value of Diagnostic Imaging,” Radiologic Clinics of North America 38, no. 1 (2000): 31–47. [DOI] [PubMed] [Google Scholar]
- 7. Wong C. K., Choi E. P. H., Chan S. W. H., et al., “Use of the International Prostate Symptom Score (IPSS) in Chinese Male Patients With Benign Prostatic Hyperplasia,” Aging Male 20, no. 4 (2017): 241–249. [DOI] [PubMed] [Google Scholar]
- 8. Fujimura T., Kume H., Nishimatsu H., et al., “Assessment of Lower Urinary Tract Symptoms in Men by International Prostate Symptom Score and Core Lower Urinary Tract Symptom Score,” BJU International 109, no. 10 (2012): 1512–1516. [DOI] [PubMed] [Google Scholar]
- 9. Lepor H., “Medical Treatment of Benign Prostatic Hyperplasia,” Reviews in Urology 13, no. 1 (2011): 20–33. [PMC free article] [PubMed] [Google Scholar]
- 10. Oelke M., Bachmann A., Descazeaud A., et al., “EAU Guidelines on the Treatment and Follow‐Up of Non‐Neurogenic Male Lower Urinary Tract Symptoms Including Benign Prostatic Obstruction,” European Urology 64, no. 1 (2013): 118–140. [DOI] [PubMed] [Google Scholar]
- 11. Pisco J. M., Pinheiro L. C., Bilhim T., Duarte M., Mendes J. R., and Oliveira A. G., “Prostatic Arterial Embolization to Treat Benign Prostatic Hyperplasia,” Journal of Vascular and Interventional Radiology 22, no. 1 (2011): 11–19; quiz 20. [DOI] [PubMed] [Google Scholar]
- 12. Sun F., Crisóstomo V., Báez‐Díaz C., and Sánchez F. M., “Prostatic Artery Embolization (PAE) for Symptomatic Benign Prostatic Hyperplasia (BPH): Part 1, Pathological Background and Clinical Implications,” Cardiovascular and Interventional Radiology 39, no. 1 (2016): 1–7. [DOI] [PubMed] [Google Scholar]
- 13. Bagla S., Martin C. P., van Breda A., et al., “Early Results From a United States Trial of Prostatic Artery Embolization in the Treatment of Benign Prostatic Hyperplasia,” Journal of Vascular and Interventional Radiology 25, no. 1 (2014): 47–52. [DOI] [PubMed] [Google Scholar]
- 14. Bagla S., Smirniotopoulos J. B., Orlando J. C., van Breda A., and Vadlamudi V., “Comparative Analysis of Prostate Volume as a Predictor of Outcome in Prostate Artery Embolization,” Journal of Vascular and Interventional Radiology 26, no. 12 (2015): 1832–1838. [DOI] [PubMed] [Google Scholar]
- 15. Bilhim T., Pisco J., Rio Tinto H., et al., “Unilateral Versus Bilateral Prostatic Arterial Embolization for Lower Urinary Tract Symptoms in Patients With Prostate Enlargement,” Cardiovascular and Interventional Radiology 36, no. 2 (2013): 403–411. [DOI] [PubMed] [Google Scholar]
- 16. Carnevale F. C., da Motta‐Leal‐Filho J. M., Antunes A. A., et al., “Quality of Life and Clinical Symptom Improvement Support Prostatic Artery Embolization for Patients With Acute Urinary Retention Caused by Benign Prostatic Hyperplasia,” Journal of Vascular and Interventional Radiology 24, no. 4 (2013): 535–542. [DOI] [PubMed] [Google Scholar]
- 17. Feng S., Tian Y., Liu W., et al., “Prostatic Arterial Embolization Treating Moderate‐to‐Severe Lower Urinary Tract Symptoms Related to Benign Prostate Hyperplasia: A Meta‐Analysis,” Cardiovascular and Interventional Radiology 40, no. 1 (2017): 22–32. [DOI] [PubMed] [Google Scholar]
- 18. Kurbatov D., Russo G. I., Lepetukhin A., et al., “Prostatic Artery Embolization for Prostate Volume Greater Than 80 cm3: Results From a Single‐Center Prospective Study,” Urology 84, no. 2 (2014): 400–404. [DOI] [PubMed] [Google Scholar]
- 19. Li Q., Duan F., Wang M. Q., Zhang G. D., and Yuan K., “Prostatic Arterial Embolization With Small Sized Particles for the Treatment of Lower Urinary Tract Symptoms Due to Large Benign Prostatic Hyperplasia: Preliminary Results,” Chinese Medical Journal 128, no. 15 (2015): 2072–2077. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20. Wang M. Q., Wang Y., Yan J. Y., et al., “Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia in Men ≥75 Years: A Prospective Single‐Center Study,” World Journal of Urology 34, no. 9 (2016): 1275–1283. [DOI] [PubMed] [Google Scholar]
- 21. Wang X., Zong H. T., and Zhang Y., “Efficacy and Safety of Prostate Artery Embolization on Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia: A Systematic Review and Meta‐Analysis,” Clinical Interventions in Aging 11 (2016): 1609–1622. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22. Carnevale F. C., Iscaife A., Yoshinaga E. M., Moreira A. M., Antunes A. A., and Srougi M., “Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic‐Controlled Analysis,” Cardiovascular and Interventional Radiology 39, no. 1 (2016): 44–52. [DOI] [PubMed] [Google Scholar]
- 23. Mirakhur A. and McWilliams J. P., “Prostate Artery Embolization for Benign Prostatic Hyperplasia: Current Status,” Canadian Association of Radiologists Journal 68, no. 1 (2017): 84–89. [DOI] [PubMed] [Google Scholar]
- 24. Napal Lecumberri S., Insausti Gorbea I., Sáez de Ocariz García A., et al., “Prostatic Artery Embolization Versus Transurethral Resection of the Prostate in the Treatment of Benign Prostatic Hyperplasia: Protocol for a Non‐Inferiority Clinical Trial,” Research and Reports in Urology 10 (2018): 17–22. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25. Zumstein V., Betschart P., Vetterlein M. W., et al., “Prostatic Artery Embolization Versus Standard Surgical Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Systematic Review and Meta‐Analysis,” European Urology Focus 5, no. 6 (2019): 1091–1100. [DOI] [PubMed] [Google Scholar]
- 26. Rosen R., Cappelleri J., Smith M., Lipsky J., and Peña B., “Development and Evaluation of an Abridged, 5‐Item Version of the International Index of Erectile Function (IIEF‐5) as a Diagnostic Tool for Erectile Dysfunction,” International Journal of Impotence Research 11, no. 6 (1999): 319–326. [DOI] [PubMed] [Google Scholar]
- 27. Pisco J. M., Bilhim T., Pinheiro L. C., et al., “Medium‐ and Long‐Term Outcome of Prostate Artery Embolization for Patients With Benign Prostatic Hyperplasia: Results in 630 Patients,” Journal of Vascular and Interventional Radiology 27, no. 8 (2016): 1115–1122. [DOI] [PubMed] [Google Scholar]
- 28. Cornelis F. H., Bilhim T., Hacking N., Sapoval M., Tapping C. R., and Carnevale F. C., “CIRSE Standards of Practice on Prostatic Artery Embolisation,” Cardiovascular and Interventional Radiology 43, no. 2 (2020): 176–185. [DOI] [PubMed] [Google Scholar]
- 29. Abt D., Hechelhammer L., Müllhaupt G., et al., “Comparison of Prostatic Artery Embolisation (PAE) Versus Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia: Randomised, Open Label, Non‐Inferiority Trial,” BMJ 361 (2018): k2338. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30. Cizman Z., Isaacson A., and Burke C., “Short‐ to Midterm Safety and Efficacy of Prostatic Artery Embolization: A Systematic Review,” Journal of Vascular and Interventional Radiology 27, no. 10 (2016): 1487–1493.e1. [DOI] [PubMed] [Google Scholar]
- 31. Pisco J. M., Rio Tinto H., Campos Pinheiro L., et al., “Embolisation of Prostatic Arteries as Treatment of Moderate to Severe Lower Urinary Symptoms (LUTS) Secondary to Benign Hyperplasia: Results of Short‐ and Mid‐Term Follow‐Up,” European Radiology 23, no. 9 (2013): 2561–2572. [DOI] [PubMed] [Google Scholar]
- 32. Parikh N., Keshishian E., Sharma A., et al., “Prostatic Artery Embolization Is Safe and Effective for Medically Recalcitrant Radiation‐Induced Prostatitis,” Advances in Radiation Oncology 5, no. 5 (2020): 905–909. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 33. Altman R., Ferreira R., Barragan C., et al., “Comparing Prostatic Artery Embolization to Surgical and Minimally Invasive Procedures for the Treatment of Benign Prostatic Hyperplasia: A Systematic Review and Meta‐Analysis,” BMC Urology 24, no. 1 (2024): 22. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 34. Ini C., Vasile T., Foti P. V., et al, “Prostate Artery Embolization as Minimally Invasive Treatment for Benign Prostatic Hyperplasia: An Updated Systematic Review,” Journal of Clinical Medicine 13, no. 9 (2024): 2530, 10.3390/jcm13092530. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 35. Malling B., Røder M. A., Brasso K., Forman J., Taudorf M., and Lönn L., “Prostate Artery Embolisation for Benign Prostatic Hyperplasia: A Systematic Review and Meta‐Analysis,” European Radiology 29, no. 1 (2019): 287–298. [DOI] [PubMed] [Google Scholar]
- 36. Sandhu J. S., Bixler B. R., Dahm P., et al., “Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023,” Journal of Urology 211, no. 1 (2024): 11–19. [DOI] [PubMed] [Google Scholar]
- 37. Bilhim T., McWilliams J. P., and Bagla S., “Updated American Urological Association Guidelines for the Management of Benign Prostatic Hyperplasia: Prostatic Artery Embolization Made It Into the Guidelines!,” Cardiovascular and Interventional Radiology 47, no. 1 (2024): 150–153. [DOI] [PubMed] [Google Scholar]
- 38. Picel A. C., Hsieh T. C., Shapiro R. M., Vezeridis A. M., and Isaacson A. J., “Prostatic Artery Embolization for Benign Prostatic Hyperplasia: Patient Evaluation, Anatomy, and Technique for Successful Treatment,” Radiographics 39, no. 5 (2019): 1526–1548. [DOI] [PubMed] [Google Scholar]
- 39. de Assis A. M., Moreira A. M., Carnevale F. C., et al., “Effects of Prostatic Artery Embolization on the Dynamic Component of Benign Prostate Hyperplasia as Assessed by Ultrasound Elastography: A Pilot Series,” Cardiovascular and Interventional Radiology 42, no. 7 (2019): 1001–1007. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.