Prostatic arterial embolisation for men with benign prostatic hyperplasia: a Cochrane review.

OBJECTIVES: To assess the effects of prostatic arterial embolisation (PAE) compared to other procedures for treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). METHODS: We included randomised controlled trials (RCTs), as well as non-randomised studies (NRSs) enrolling men with BPH undergoing PAE vs other surgical interventions via a comprehensive search up until 8 November 2021. Two independent reviewers screened the literature, extracted data, assessed risk of bias, performed statistical analyses by using a random-effects model, and rated the certainty of evidence (CoE) of RCTs and NRSs. RESULTS: We found data to inform two comparisons: PAE vs transurethral resection of prostate (TURP; six RCTs and two NRSs), and PAE vs sham (one RCT). This abstract focuses on the primary outcomes in a comparison of PAE vs TURP. Short-term follow-up: based on RCT evidence, there may be little to no difference in urological symptom score improvement (mean difference [MD] 1.72, 95% confidence interval [CI] -0.37 to 3.81; low CoE) and quality of life (QoL; MD 0.28, 95% CI -0.28 to 0.84; low CoE) measured by International Prostatic Symptom Score. We are very uncertain about the effects of PAE on major adverse events (risk ratio [RR] 0.75, 95% CI 0.19-2.97; very low CoE). Long-term follow-up: based on RCT evidence, PAE may result in little to no difference in urological symptom scores (MD 2.58, 95% CI -1.54 to 6.71; low CoE) and QoL (MD 0.50, 95% CI -0.03 to 1.04; low CoE). We are very uncertain about major adverse events (RR 0.91, 95% CI 0.20-4.05; very low CoE). CONCLUSION: Compared to TURP, the impact on urological symptoms and QoL improvement as perceived by patients appears to be similar. This review did reveal major uncertainty as to how major adverse events compare.

Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.

BACKGROUND: A variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Prostatic arterial embolization (PAE) is a relatively new, minimally invasive treatment approach. OBJECTIVES: To assess the effects of PAE compared to other procedures for treatment of LUTS in men with BPH. SEARCH METHODS: We performed a comprehensive search the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of grey literature, and conference proceedings with no restrictions on language of publication or publication status, up to 8 November 2021. SELECTION CRITERIA: We included parallel-group randomized controlled trials (RCTs), as well as non-randomized studies (NRS, limited to prospective cohort studies with concurrent comparison groups) enrolling men over the age of 40 years with LUTS attributed to BPH undergoing PAE versus TURP or other surgical interventions.  DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies for inclusion or exclusion and abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence of RCTs and NRSs.  MAIN RESULTS: We found data to inform two comparisons: PAE versus TURP (six RCTs and two NRSs), and PAE versus sham (one RCT). Mean age was 66 years, International Prostate Symptom Score (IPSS) was 22.8, and prostate volume of participants was 72.8 mL. This abstract focuses on the comparison of PAE versus TURP as the primary topic of interest. Prostatic arterial embolization versus transurethral resection of the prostate We included six RCTs and two NRSs with short-term (up to 12 months) follow-up, and two RCTs and one NRS with long-term follow-up (13 to 24 months).  Short-term follow-up: based on RCT evidence, there may be little to no difference in urologic symptom score improvement measured by the International Prostatic Symptom Score (IPSS) on a scale from 0 to 35, with higher scores indicating worse symptoms (mean difference [MD] 1.72, 95% confidence interval [CI] -0.37 to 3.81; 6 RCTs, 360 participants; I² = 78%; low-certainty evidence). There may be little to no difference in quality of life as measured by the IPSS-quality of life question on a scale from 0 to 6, with higher scores indicating worse quality of life between PAE and TURP, respectively (MD 0.28, 95% CI -0.28 to 0.84; 5 RCTs, 300 participants; I² = 63%; low-certainty evidence). While we are very uncertain about the effects of PAE on major adverse events (risk ratio [RR] 0.75, 95% CI 0.19 to 2.97; 4 RCTs, 250 participants; I² = 24%; very low-certainty evidence), PAE likely increases retreatments (RR 3.20, 95% CI 1.41 to 7.27; 4 RCTs, 303 participants; I² = 0%; moderate-certainty evidence). PAE may make little to no difference in erectile function measured by the International Index of Erectile Function-5 on a scale from 1 to 25, with higher scores indicating better function (MD -0.50 points, 95% CI -5.88 to 4.88; 2 RCTs, 120 participants; I² = 68%; low-certainty evidence). Based on NRS evidence, PAE may reduce the occurrence of ejaculatory disorders (RR 0.51, 95% CI 0.35 to 0.73; 1 NRS, 260 participants; low-certainty evidence). Long-term follow-up: based on RCT evidence, PAE may result in little to no difference in urologic symptom scores (MD 2.58 points, 95% CI -1.54 to 6.71; 2 RCTs, 176 participants; I² = 73%; low-certainty evidence) and quality of life (MD 0.50 points, 95% CI -0.03 to 1.04; 2 RCTs, 176 participants; I² = 29%; low-certainty evidence). We are very uncertain about major adverse events (RR 0.91, 95% CI 0.20 to 4.05; 2 RCTs, 206 participants; I² = 72%; very low-certainty evidence). PAE likely increases retreatments (RR 3.80, 95% CI 1.32 to 10.93; 1 RCT, 81 participants; moderate-certainty evidence). While PAE may result in little to no difference in erectile function (MD 3.09 points, 95% CI -0.76 to 6.94; 1 RCT, 81 participants; low-certainty evidence), PAE may reduce the occurrence of ejaculatory disorders (RR 0.67, 95% CI 0.45 to 0.98; 1 RCT, 50 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: Compared to TURP, PAE may provide similar improvement in urologic symptom scores and quality of life. While we are very uncertain about major adverse events, PAE likely increases retreatment rates. While erectile function may be similar, PAE may reduce ejaculatory disorders. Certainty of evidence for the outcomes of this review was low or very low except for retreatment (moderate-certainty evidence), signaling that our confidence in the reported effect size is limited or very limited, and that this topic should be better informed by future research.

Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.

BACKGROUND: A variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Prostatic arterial embolization (PAE) is a relatively new, minimally invasive treatment approach. OBJECTIVES: To assess the effects of PAE compared to other procedures for treatment of LUTS in men with BPH. SEARCH METHODS: We performed a comprehensive search using multiple databases (The Cochrane Library, MEDLINE, Embase, LILACS, Scopus, Web of Science, and Google Scholar), trials registries, other sources of grey literature, and conference proceedings with no restrictions on language of publication or publication status, up until 25 September 2020. SELECTION CRITERIA: We included parallel-group randomized controlled trials (RCTs), as well as non-randomized studies (NRS, limited to prospective cohort studies with concurrent comparison groups) enrolling men over the age of 40 with LUTS attributed to BPH undergoing PAE versus TURP or other surgical interventions.  DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies for inclusion or exclusion and abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence of RCTs and NRSs.  MAIN RESULTS: We found data to inform two comparisons: PAE versus TURP (six RCTs and two NRSs), and PAE versus sham (one RCT). Mean age, IPSS, and prostate volume of participants were 66 years, 22.8, and 72.8 mL, respectively. This abstract focuses on the comparison of PAE versus TURP as the primary topic of interest. PAE versus TURP We included six RCTs and two NRSs with short-term (up to 12 months) follow-up and one RCT with long-term follow-up (13 to 24 months).  Short-term follow-up: based on RCT evidence, there may be little to no difference in urologic symptom score improvement (mean difference [MD] 1.55, 95% confidence interval [CI] -0.40 to 3.50; 369 participants; 6 RCTs; I² = 75%; low-certainty evidence) measured by the International Prostatic Symptom Score (IPSS) on a scale from 0 to 35, with higher scores indicating worse symptoms. There may be little to no difference in quality of life (MD 0.16, 95% CI -0.37 to 0.68; 309 participants; 5 RCTs; I² = 56%; low-certainty evidence) as measured by the IPSS quality of life question on a scale from 0 to 6, with higher scores indicating worse quality of life between PAE and TURP, respectively. While we are very uncertain about the effects of PAE on major adverse events (risk ratio [RR] 0.71, 95% CI 0.16 to 3.10; 250 participants; 4 RCTs; I² = 26%; very low-certainty evidence), PAE may increase re-treatments (RR 3.64, 95% CI 1.02 to 12.98; 204 participants; 3 RCTs; I² = 0%; low-certainty evidence). Based on 18 re-treatments per 1000 men in the TURP group, this corresponds to 47 more (0 more to 214 more) per 1000 men undergoing PAE.   We are very uncertain about the effects on erectile function (MD -0.03, 95% CI -6.35 to 6.29; 129 participants; 2 RCTs; I² = 78%; very low-certainty evidence) measured by the International Index of Erectile Function at 5 on a scale from 1 to 25, with higher scores indicating better function. NRS evidence when available yielded similar results. Based on evidence from NRS, PAE may reduce the occurrence of ejaculatory disorders (RR 0.51, 95% CI 0.35 to 0.73; 260 participants; 1 NRS; low-certainty evidence). Longer-term follow-up: based on RCT evidence, we are very uncertain about the effects of PAE on urologic symptom scores (MD 0.30, 95% CI -3.17 to 3.77; 95 participants; very low-certainty evidence) compared to TURP. Quality of life may be similar (MD 0.20, 95% CI -0.49 to 0.89; 95 participants; low-certainty evidence). We are also very uncertain about major adverse events (RR 1.96, 95% CI 0.63 to 6.13; 107 participants; very low-certainty evidence). We did not find evidence on erectile function and ejaculatory disorders. Based on evidence from NRS, PAE may increase re-treatment rates (RR 1.51, 95% CI 0.43 to 5.29; 305 participants; low-certainty evidence); based on 56 re-treatments per 1000 men in the TURP group. this corresponds to 143 more (25 more to 430 more) per 1000 men in the PAE group.  AUTHORS' CONCLUSIONS: Compared to TURP up to 12 months (short-term follow-up), PAE may provide similar improvement in urologic symptom scores and quality of life. While we are very uncertain about major adverse events, PAE may increase re-treatment rates. We are uncertain about erectile function, but PAE may reduce ejaculatory disorders. Longer term (follow-up of 13 to 24 months), we are very uncertain as to how both procedures compare with regard to urologic symptom scores, but quality of life appears to be similar. We are very uncertain about major adverse events but PAE may increase re-treatments. We did not find longer term evidence on erectile function and ejaculatory disorders. Certainty of evidence for the main outcomes of this review was low or very low, signalling that our confidence in the reported effect size is limited or very limited, and that this topic should be better informed by future research.

Prostatic urethral lift for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.

BACKGROUND: A variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of prostate (TURP) for the management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). A recent addition to these is prostatic urethral lift (PUL). OBJECTIVES: To assess the effects of PUL for the treatment of LUTS in men with BPH. SEARCH METHODS: We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, LILACS, Scopus, Web of Science, and Google Scholar), trials registries, other sources of grey literature, and conference proceedings with no restrictions on the language of publication or publication status up until 31 January 2019. SELECTION CRITERIA: We included parallel group randomized controlled trials (RCTs). While we planned to include non-RCTs if RCTs had provided low-certainty evidence for a given outcome and comparison, we could not find any non-RCTs. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We planned subgroup analyses by age, prostate volume, and severity of baseline symptoms. We used the GRADE approach to rate the certainty of the evidence. MAIN RESULTS: We included two RCTs with 297 participants comparing PUL to sham surgery or TURP. The mean age was 65.6 years and mean International Prostate Symptom Score was 22.7. Mean prostate volume was 42.2 mL. We considered review outcomes measured up to and including 12 months after randomization as short-term and later than 12 months as long-term. For patient-reported outcomes, lower scores indicate more urological symptom improvement and higher quality of life. In contrast, higher scores refers to better erectile and ejaculatory function.PUL versus sham: based on one study of 206 randomized participants with short follow-up (up to three months), PUL may lead to a clinically important improvement in urological symptom scores (mean difference (MD) -5.20, 95% confidence interval (CI) -7.44 to -2.96; low-certainty evidence) and likely improves quality of life (MD -1.20, 95% CI -1.67 to -0.73; moderate-certainty evidence). We are uncertain whether PUL increases major adverse events (very low-certainty evidence). There were no retreatments reported in either study group by three months. PUL likely results in little to no difference in erectile function (MD -1.40, 95% CI -3.24 to 0.44; moderate-certainty evidence) and ejaculatory function (MD 0.50, 95% CI -0.38 to 1.38; moderate-certainty evidence).PUL versus TURP: based on one study of 91 randomized participants with a short follow-up (up to 12 months), PUL may result in a substantially lesser improvement in urological symptom scores than TURP (MD 4.50, 95% CI 1.10 to 7.90; low-certainty evidence). PUL may result in a slightly reduced or similar quality of life (MD 0.30, 95% CI -0.49 to 1.09; low-certainty evidence). We are very uncertain whether PUL may cause fewer major adverse events but increased retreatments (both very low-certainty evidence). PUL probably results in little to no difference in erectile function (MD 0.80, 95% CI -1.50 to 3.10; moderate-certainty evidence), but probably results in substantially better ejaculatory function (MD 5.00, 95% CI 3.08 to 6.92; moderate-certainty evidence).With regards to longer term follow-up (up to 24 months) based on one study of 91 randomized participants, PUL may result in a substantially lesser improvement in urological symptom score (MD 6.10, 95% CI 2.16 to 10.04; low-certainty evidence) and result in little worse to no difference in quality of life (MD 0.80, 95% CI 0.00 to 1.60; low-certainty evidence). The study did not report on major adverse events. We are very uncertain whether PUL increases retreatment (very low-certainty evidence). PUL likely results in little to no difference in erectile function (MD 1.60, 95% CI -0.80 to 4.00; moderate-certainty evidence), but may result in substantially better ejaculatory function (MD 4.30, 95% CI 2.17 to 6.43; low-certainty evidence).We were unable to perform any of the predefined secondary analyses for either comparison.We found no evidence for other comparisons such as PUL versus laser ablation or enucleation. AUTHORS' CONCLUSIONS: PUL appears less effective than TURP in improving urological symptoms both short-term and long term, while quality of life outcomes may be similar. The effect on erectile function appears similar but ejaculatory function may be better. We are uncertain about major adverse events short-term and found no long-term information. We are very uncertain about retreatment rates both short-term and long-term. We were unable to assess the effects of PUL in subgroups based on age, prostate size, or symptom severity and also could not assess how PUL compared to other surgical management approaches. Given the large numbers of alternative treatment modalities to treat men with LUTS secondary to BPH, this represents important information that should be shared with men considering surgical treatment.