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Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study.
To describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE).
This was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics.
Four hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all p < 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all p < 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE.
PAE is a safe and effective treatment for symptomatic BPH and LUTS. Level of Evidence Level 3 Trial registration ClinicalTrials.gov NCT03527589.
Sapoval MR
,Bhatia S
,Déan C
,Rampoldi A
,Carnevale FC
,Bent C
,Tapping CR
,Bongiovanni S
,Taylor J
,Brower JS
,Rush M
,McWilliams JP
,Little MW
,PROstate Study Investigators
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Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Obstruction: 5-year Outcomes of a Randomised, Open-label, Noninferiority Trial.
Prostatic artery embolisation (PAE) and transurethral resection of the prostate (TURP) are two of the surgical options for treatment of lower urinary tract symptoms/benign prostatic obstruction (LUTS/BPO). Our aim was to compare the efficacy and safety of PAE and TURP for LUTS/BPO treatment at long-term follow-up.
We conducted a randomised, open-label, single-centre trial at a Swiss tertiary care centre. The main outcome was the change in International Prostate Symptom Score (IPSS) after PAE versus TURP. Secondary outcomes included patient-reported outcomes, functional measures, and adverse events assessed at baseline and at 3, 6, 12, 24, and 60 mo. Between-group differences in the change from baseline to 5 yr were tested using two-sided Mann-Whitney and t tests.
Of the 103 patients with refractory LUTS/BPO who were randomised between 2014 and 2017, 18/48 who underwent PAE and 38/51 who underwent TURP reached the 60-mo follow-up visit. The mean reduction in IPSS from baseline to 5 yr was -7.78 points after PAE and -11.57 points after TURP (difference 3.79 points, 95% confidence interval [CI] -0.66 to 8.24; p = 0.092). TURP was superior for most patient-reported secondary outcomes except for erectile function. At 5 yr, PAE was less effective than TURP regarding objective parameters, such as the improvement in maximum urinary flow rate (3.59 vs 9.30 ml/s, difference -5.71, 95% CI -10.72 to -0.70; p = 0. 027) and reduction in postvoid residual volume (27.81 vs 219.97 ml; difference 192.15, 95% CI 83.79-300.51; p = 0.001).
The improvement in LUTS/BPO at 5 yr after PAE was inferior to that achieved with TURP. The limitations of PAE should be considered during patient selection and counselling.
In this study, we show the long-term results of prostate artery embolisation (PAE) in comparison to transurethral resection of the prostate (TURP) for the treatment of benign prostate enlargement causing urinary symptoms. PAE shows good long-term results in properly selected patients, although the improvements are less pronounced than with TURP. This trial is registered on ClinicalTrials.gov as NCT02054013.
Müllhaupt G
,Hechelhammer L
,Graf N
,Mordasini L
,Schmid HP
,Engeler DS
,Abt D
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《European Urology Focus》
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The 'Prostate Embolisation AS first-line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial' (P-EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH.
To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first-line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment-naïve patients in the 'Prostate Embolisation AS first-line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial' (P-EASY ADVANCE).
A total of 39 men with enlarged prostates, moderate-severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow-up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short- to medium-term intervals following interventions and compared to baseline.
The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P < 0.001), incomplete emptying (P = 0.002), total IPSS (P = 0.032), Qmax (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group.
Prostate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment-naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.
Brown N
,Kiosoglous A
,Castree S
,Firouzmand S
,McBean R
,Walker DG
,Wallace S
,Kua B
,Gianduzzo T
,Esler RC
,Campbell P
,Schoeman J
,Yaxley J
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Prostatic Artery Embolization: Mid- to Long-Term Outcomes in 1,075 Patients.
To assess the mid- to long-term safety and effectiveness of prostatic artery embolization (PAE) at a single-center cohort of 1,075 patients.
This institutional review board-approved retrospective study included patients with moderate-to-severe lower urinary tract symptoms (LUTS) or urinary retention who underwent PAE from January 2014 to July 2023. Patients were assessed at 1, 3, 6, and 12 months after PAE and yearly thereafter. The International Prostate Symptom Score (IPSS), quality of life (QoL) score, International Index of Erectile Function-5 (IIEF-5) score, prostate-specific antigen (PSA), prostate volume (PV), postvoid residual, benign prostatic obstruction (BPO) medication usage, urinary catheter status, and further prostatic interventions were assessed. Adverse events were recorded and classified using the Society of Interventional Radiology (SIR) adverse events (AEs) severity classification.
The mean follow-up was 458.4 days (SD ± 559.5). The mean age was 70.4 years (SD ± 9.0), the median (interquartile range) PV was 107 g (76-150 g), and the median preprocedural IPSS, QoL, and IIEF-5 scores and PSA level were 23 (18-28), 5 (4-6), 17 (10-21), and 4.7 ng/mL (2.6-8), respectively. In the LUTS subgroup, at 1-3, 6-12, and 48-60 months, the median IPSS values were 7 (4-12, P < .001), 6 (3-11, P < .001), and 9 (4-15, P < .001), respectively. The QoL scores at the same time points were 2 (1-2, P < .001), 1 (0-2, P < .001), 2 (0-3, P < .001), respectively. Of 126 patients in the retention cohort, 119 (94%) were catheter-free at the 3-month follow-up. Ninety-patients (16% of reintervention eligible patients) required a second prostatic intervention up to 60 months after PAE. After PAE, 65.5% of patients were BPO medication-free at 1 year. Seven patients (0.65%) had severe AEs according to the SIR AE severity classification: (a) transient ischemic attacks, 3; (b) urosepsis, 2 (treated in the inpatient setting with intravenous antibiotics); and (c) prostate sloughing, 2 (needing transurethral resection of the prostate). All AEs resolved without permanent sequelae.
In a large cohort with long-term longitudinal follow-up, PAE showed significant, sustained long-term relief of LUTS, improved QoL, low reintervention rate, and high BPO medication-free rates. Ninety-four percent of catheter-dependent patients at baseline were catheter-free at 3 months.
Bhatia S
,Bhatia A
,Richardson AJ
,Richardson K
,Issa C
,Kumar JG
,Jalaiean H
,Kava B
,Shah HN
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Technological innovation of HoLEP: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
The purpose of this study was to investigate the efficacy of Transurethral Holmium Laser of the Prostate (HoLEP) with Double-n Technology in the treatment of benign prostatic hyperplasia (BPH), with a focus on preserving sexual function postoperatively.
Conducted as a multicenter, prospective, single-blind randomized controlled trial, this study enrolled sexually active male patients with BPH. Participants were randomized into three groups: standard HoLEP (Group A), single-n technology (Group B), and innovative double-n technology (Group C), which emphasizes the preservation of the urethral mucosa and nearby structures. The primary endpoints included maximum urinary flow rate (Qmax), International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF).
Of the 180 initial participants, 139 completed the study. All groups showed significant improvements in Qmax and IPSS. Initial declines in IIEF scores were noted across all groups, stabilizing to baseline by 3 months without further improvement. Group A had modest antegrade ejaculation rates, starting at 15.4% at 3 months and reaching 23.1% at 12 months. Group B showed a significant improvement, with AE rates rising from 31.8% at 3 months to 45.5% at 12 months, significantly higher than Group A (p < 0.05). Group C had the highest AE rates, starting at 57.8% at 3 months and reaching 77.8% at 12 months, significantly surpassing both Group A and B (p < 0.05). Regarding semen reduction, Group A had 100% reduction at 3 months, which decreased to 77.8% at 12 months. Group B followed a similar trend, from 100% at 3 months to 68.2% at 12 months. Group C showed a more pronounced decline, starting at 84.6% at 3 months and dropping to 37.1% at 12 months, with values significantly lower than both Groups A and B (p < 0.05).
The double-n HoLEP technique shows promising results in improving urinary symptoms while better preserving ejaculatory function and sexual quality of life in BPH patients. This technique could offer a significant advancement in the surgical management of BPH, particularly for sexually active patients.
Gao Z
,Wang P
,Liu H
,Ding Y
,Xu L
,Sun Z
,Du R
,Gu L
,Shen Y
,Wang R
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