Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial.

BACKGROUND: One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. METHODS: This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. DISCUSSION: In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Obstruction: 5-year Outcomes of a Randomised, Open-label, Noninferiority Trial.

BACKGROUND AND OBJECTIVE: 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. METHODS: 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. KEY FINDINGS AND LIMITATIONS: 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). CONCLUSIONS AND CLINICAL IMPLICATIONS: 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. PATIENT SUMMARY: 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.

Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.

Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively. Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months. Funding: French Ministry of Health and a complementary grant from Merit Medical.

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Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in men. When drug treatment is ineffective or conventional surgery is not suitable, novel minimally invasive therapies can be considered. These include prostatic urethral lift, prostatic artery embolisation, water vapor thermal therapy, Aquablation-image guided robotic waterjet ablation, temporary implantable nitinol device and prostatic stents. These novel therapies can be performed in outpatient setting under local anesthesia, with shorter operative and recovery times, and better protection of ejaculatory function and erectile function. General conditions of the patient and advantages and disadvantages of the each of these therapies should be fully considered to make individualized plans.

Six novel minimally invasive therapies for benign prostatic hyperplasia / 浙江大学学报·医学版

Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in men. When drug treatment is ineffective or conventional surgery is not suitable, novel minimally invasive therapies can be considered. These include prostatic urethral lift, prostatic artery embolisation, water vapor thermal therapy, Aquablation-image guided robotic waterjet ablation, temporary implantable nitinol device and prostatic stents. These novel therapies can be performed in outpatient setting under local anesthesia, with shorter operative and recovery times, and better protection of ejaculatory function and erectile function. General conditions of the patient and advantages and disadvantages of the each of these therapies should be fully considered to make individualized plans.

Prostatic Artery Embolisation: Do We Still Need It and for Whom?

Prostatic artery embolisation (PAE) is now endorsed by international evidence-based guidelines as a treatment for lower urinary tract symptoms presumed secondary to benign prostatic obstruction (LUTS/BPO) for selected patients. PAE is a truly minimally invasive technique, with proven efficacy and safety demonstrated for the short- to mid-term. As it has a unique treatment approach (endovascular instead of transurethral), its profile and ideal application differ clearly from other treatments for LUTS/BPO, which must be considered for patient selection. This mini review examines the role of PAE in the treatment of LUTS/BPO on the basis of current evidence. PATIENT SUMMARY: For properly selected patients, prostatic artery embolisation (PAE), in which arteries feeding the prostate are blocked in a nonsurgical procedure, is one of the treatment options for obstruction of urine outflow caused by benign enlargement of the prostate. This article examines the role of PAE according to the evidence available in the literature.

Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single-centre Trial.

BACKGROUND: Prostatic artery embolisation (PAE) for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction (LUTS/BPO) still remains under investigation. OBJECTIVE: To compare the efficacy and safety of PAE and transurethral resection of the prostate (TURP) in the treatment of LUTS/BPO at 2 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A randomised, open-label trial was conducted. There were 103 participants aged ≥40 yr with refractory LUTS/BPO. INTERVENTION: PAE versus TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: International Prostate Symptoms Score (IPSS) and other questionnaires, functional measures, prostate volume, and adverse events were evaluated. Changes from baseline to 2 yr were tested for differences between the two interventions with standard two-sided tests. RESULTS AND LIMITATIONS: The mean reduction in IPSS after 2 yr was 9.21 points after PAE and 12.09 points after TURP (difference of 2.88 [95% confidence interval 0.04-5.72]; p = 0.047). Superiority of TURP was also found for most other patient-reported outcomes except for erectile function. PAE was less effective than TURP regarding the improvement of maximum urinary flow rate (3.9 vs 10.23 ml/s, difference of -6.33 [-10.12 to -2.54]; p < 0.001), reduction of postvoid residual urine (62.1 vs 204.0 ml; 141.91 [43.31-240.51]; p = 0.005), and reduction of prostate volume (10.66 vs 30.20 ml; 19.54 [7.70-31.38]; p = 0.005). Adverse events were less frequent after PAE than after TURP (total occurrence n = 43 vs 78, p = 0.005), but the distribution among severity classes was similar. Ten patients (21%) who initially underwent PAE required TURP within 2 yr due to unsatisfying clinical outcomes, which prevented further assessment of their outcomes and, therefore, represents a limitation of the study. CONCLUSIONS: Inferior improvements in LUTS/BPO and a relevant re-treatment rate are found 2 yr after PAE compared with TURP. PAE is associated with fewer complications than TURP. The disadvantages of PAE regarding functional outcomes should be considered for patient selection and counselling. PATIENT SUMMARY: Prostatic artery embolisation is safe and effective. However, compared with transurethral resection of the prostate, its disadvantages regarding subjective and objective outcomes should be considered for individual treatment choices.

Radiation Exposure During Prostatic Artery Embolisation: A Systematic Review and Calculation of Associated Risks.

Although evidence supporting the efficacy and safety of prostatic artery embolisation (PAE) is increasing, potential associated risks of ionising radiation in this context remain largely unknown. We systematically reviewed reports on radiation exposure (RE) during PAE in the literature and estimated the risk RE poses using a Monte Carlo dose calculation algorithm. Of 842 studies screened, 22 were included. The overall mean dose area product (DAP) was 181.6 Gy∙cm2 (95% confidence interval 125.7-262.4). The risk model for the effects of RE in a 66-yr-old patient exposed to DAP of 200 Gy∙cm2 showed that the probability of cancer death from the intervention was 0.117%. The highest specific lifetime risk was expected for leukaemia (0.061%). Wide DAP variation between individual studies (medians ranging from 33.2 to 863.4 Gy∙cm2) indicate large potential to reduce RE during PAE at some study centres. RE must be included in patient counselling on PAE, especially for younger patients. PATIENT SUMMARY: We systematically assessed radiation exposure during prostatic artery embolisation (PAE) in the literature and simulated the associated risks in a computer model. PAE exposes patients to very low but not negligible risks, which are most relevant for younger men. This should be discussed with patients before PAE.

The role of novel minimally invasive treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia.

OBJECTIVES: To provide an update on novel minimally invasive lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) treatments in a non-systematic review. To define potential target populations for the various new minimally invasive treatments. METHODS: Recent literature, meta-analyses and guideline recommendations for aquablation (AquaBeam® ; PROCEPT BioRobotics, Redwood City, CA, USA), water vapour thermal therapy (Rezum® ; Boston Scientific, Natick, MA, USA), prostate artery embolisation (PAE), prostatic urethral lift (UroLift® ; NeoTract-Teleflex, Pleasanton, CA, USA) and the temporary implantable nitinol device [i-TIND® (nitinol butterfly-like stent ); Medi-Tate Ltd., Or-Akiva, Israel] were reviewed. RESULTS: Procedures that can be performed on an outpatient basis (Rezum, PAE, UroLift and i-TIND) are not an alternative for the standard patient requiring BPH surgery. Their effect on urinary flow, post-void residual urine volume or bladder outlet obstruction is less pronounced than that of transurethral resection of the prostate (TURP). Yet, these options appear to be valuable for those patients unfit for surgery, men who want to avoid medical therapy in general, or those who want to avoid sexual side-effects associated with medical therapy or standard BPH surgery (e.g. TURP). Aquablation is the first successfully operationalised robotic resection system, especially for patients with prostates >50 g. Nevertheless, long-term data are necessary for all novel, minimally invasive treatments. CONCLUSIONS: Better designed clinical trials, a clearer definition of target populations and a more realistic marketing allow a better characterisation of novel minimally invasive therapies for LUTS/BPH. It is hoped that some of these novel devices will stand the test of time, in contrast to the vast majority of their predecessors.