Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia
- PMID: 33368143
- PMCID: PMC8728637
- DOI: 10.1002/14651858.CD012867.pub2
Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia
Update in
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Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012867. doi: 10.1002/14651858.CD012867.pub3. Cochrane Database Syst Rev. 2022. PMID: 35349161 Free PMC article.
Abstract
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.
پیشینه: طیفی از رویکردهای جراحی کمتهاجمیتر بهعنوان گزینههای درمانی جایگزین رزکسیون پروستات از طریق مجاری ادراری (transurethral resection of the prostate; TURP) در مدیریت نشانههای دستگاه ادراری تحتانی (lower urinary tract symptoms; LUTS) در مردان مبتلا به هیپرپلازی خوشخیم پروستات (benign prostatic hyperplasia; BPH) پیشنهاد شدهاند. آمبولیزاسیون شریانی پروستات (prostatic arterial embolization; PAE) یک روش درمانی نسبتا جدید و کم تهاجمی است. اهداف: ارزیابی اثرات PAE در مقایسه با سایر روشهای درمان LUTS در مردان مبتلا به BPH. روشهای جستوجو: ما جستوجوی جامعی را در بانکهای اطلاعاتی مختلف (کتابخانه کاکرین، MEDLINE؛ Embase؛ LILACS؛ Scopus؛ Web of Science؛ و Google Scholar)، پایگاههای ثبت کارآزماییها، سایر منابع علمی منتشر نشده، و مجموعه مقالات کنفرانس منتشر شده تا 25 سپتامبر 2020، بدون اعمال محدودیت در زبان یا وضعیت انتشار، انجام دادیم. معیارهای انتخاب: ما کارآزماییهای تصادفیسازی و کنترل شده (randomised controlled trials; RCTs)، همچنین مطالعات غیر‐تصادفیسازی شده (NRS، محدود به مطالعات کوهورت آیندهنگر با گروههای مقایسه همزمان) را با حضور مردان بالای 40 سال مبتلا به LUTS وارد کردیم که نشانههایشان به BPH نسبت داده شد و تحت PAE در مقابل TURP یا سایر مداخلات جراحی قرار گفتند. گردآوری و تجزیهوتحلیل دادهها: دو نویسنده مرور بهطور مستقل از هم مطالعات را برای ورود و خروج طبقهبندی کرده و دادهها را از مطالعات وارد شده خلاصه کردند. ما تجزیهوتحلیل آماری را با استفاده از یک مدل اثرات تصادفی انجام دادیم و آنها را مطابق با کتابچه راهنمای کاکرین برای مرورهای سیستماتیک مداخلات تفسیر کردیم. برای ارزیابی قطعیت شواهد RCTها و NRSها از راهنمایی GRADE استفاده شد. نتایج اصلی: ما دادههایی را برای آگاهی از دو مقایسه یافتیم: PAE در مقابل TURP (شش RCT و دو NRS)، و PAE در مقابل روش ساختگی (یک RCT). میانگین سنی، IPSS، و حجم پروستات شرکتکنندگان، به ترتیب 66 سال، 22.8 و 72.8 میلیلیتر بود. این چکیده متمرکز است بر مقایسه PAE در مقابل TURP به عنوان موضوع اصلی مورد نظر. PAE در مقابل TURP ما شش RCT و دو NRS را با پیگیری کوتاهمدت (تا 12 ماه) و یک RCT را با پیگیری طولانیمدت (13 تا 24 ماه) وارد کردیم. پیگیری کوتاهمدت: بر اساس شواهد به دست آمده از RCT، ممکن است تفاوتی اندک یا عدم تفاوت در بهبود نمره نشانههای اورولوژیک وجود داشته باشد (تفاوت میانگین [MD]: 1.55؛ 95% فاصله اطمینان [CI]: 0.40‐ تا 3.50؛ 369 شرکتکننده؛ 6 RCT؛ I² = 75%؛ شواهد با قطعیت پائین) که با نمره بینالمللی نشانههای پروستات (International Prostatic Symptom Score; IPSS) در مقیاس 0 تا 35 اندازهگیری شد، و نمرات بالاتر نشانههای بدتر را نشان میدهد. در کیفیت زندگی نیز ممکن است تفاوتی اندک یا عدم تفاوت وجود داشته باشد (MD: 0.16؛ 95% CI؛ 0.37‐ تا 0.68؛ 309 شرکتکننده؛ 5 RCT؛ I² = 56%؛ شواهد با قطعیت پائین) که توسط سوال کیفیت زندگی IPSS در یک مقیاس 0 تا 6 اندازهگیری شد، و نمرات بالاتر نشانگر کیفیت زندگی بدتر به ترتیب بین PAE و TURP است. در حالی که ما در مورد تأثیر PAE بر عوارض جانبی عمده بسیار نامطمئن هستیم (خطر نسبی [RR]: 0.71؛ 95% CI؛ 0.16 تا 3.10؛ 250 شرکتکننده؛ 4 RCT؛ I² = 26%؛ شواهد با قطعیت بسیار پائین)، PAE ممکن است نیاز را به درمان مجدد افزایش دهد (RR: 3.64؛ 95% CI؛ 1.02 تا 12.98؛ 204 شرکتکننده؛ 3 RCT؛ I² = 0%؛ شواهد با قطعیت بسیار پائین). بر اساس 18 مورد درمان مجدد در هر 1000 مرد در گروه TURP، این عدد متناظر است با 47 مورد دیگر (0 مورد بیشتر تا 214 مورد بیشتر) در هر 1000 مرد تحت درمان با PAE. ما در مورد اثرات درمان بر عملکرد نعوظ بسیار نامطمئن هستیم (MD: ‐0.03؛ 95% CI؛ 6.35‐ تا 6.29؛ 129 شرکتکننده؛ 2 RCT؛ I² = 78%؛ شواهد با قطعیت بسیار پائین) که توسط شاخص بینالمللی عملکرد نعوظ در 5 روی مقیاس 1 تا 25 اندازهگیری شد، که نمرات بالاتر نشان دهنده عملکرد بهتر است. شواهد NRS در صورت وجود، نتایج مشابهی را به همراه داشت. براساس شواهد به دست آمده از NRS، روش PAE ممکن است بروز اختلالات انزال را کاهش دهد (RR: 0.51؛ 95% CI؛ 0.35 تا 0.73؛ 260 شرکتکننده؛ 1 NRS؛ شواهد با قطعیت پائین). پیگیری طولانیمدتتر: براساس شواهد RCT، ما در مورد تأثیر PAE بر نمرات نشانههای اورولوژیک، در مقایسه با TURP، بسیار نامطمئن هستیم (MD: 0.30؛ 95% CI؛ 3.17‐ تا 3.77؛ 95 شرکتکننده؛ شواهد با قطعیت بسیار پائین). کیفیت زندگی ممکن است مشابه باشد (MD: 0.20؛ 95% CI؛ 0.49‐ تا 0.89؛ 95 شرکتکننده؛ شواهد با قطعیت پائین). ما همچنین در مورد حوادث عمده جانبی بسیار نامطمئن هستیم (RR: 1.96؛ 95% CI؛ 0.63 تا 6.13؛ 107 شرکتکننده؛ شواهد با قطعیت بسیار پائین). ما شواهدی را در مورد عملکرد نعوظ و اختلالات انزال پیدا نکردیم. بر اساس شواهد به دست آمده از NRS، روش PAE ممکن است نرخ درمان مجدد را افزایش دهد (RR: 1.51؛ 95% CI؛ 0.43 تا 5.29؛ 305 شرکتکننده؛ شواهد با قطعیت پائین)؛ بر اساس 56 مورد نیاز به درمان مجدد در هر 1000 مرد در گروه TURP. این متناظر است با 143 نفر بیشتر (25 نفر بیشتر تا 430 نفر بیشتر) در هر 1000 مرد در گروه PAE. نتیجهگیریهای نویسندگان: در مقایسه با TURP تا 12 ماه (پیگیری کوتاهمدت)، PAE ممکن است میزان بهبودی مشابهی را در نمرات نشانههای اورولوژیک و کیفیت زندگی ایجاد کند. در حالی که در مورد عوارض جانبی عمده بسیار نامطمئن هستیم، PAE ممکن است نرخ درمان مجدد را افزایش دهد. ما در مورد عملکرد نعوظ اطمینان نداریم، اما PAE ممکن است اختلالات انزال را کاهش دهد. با پیگیری طولانیمدتتر (13 تا 24 ماه)، در مورد اینکه هر دو روش با توجه به نمرات نشانههای اورولوژیک چگونه مقایسه میشوند، بسیار نامطمئن هستیم، اما به نظر میرسد کیفیت زندگی مشابه باشد. در مورد عوارض جانبی عمده بسیار نامطمئن هستیم، اما PAE ممکن است نرخ درمان مجدد را افزایش دهد. شواهد طولانیمدتتری را در مورد عملکرد نعوظ و اختلالات انزال پیدا نکردیم. قطعیت شواهد برای پیامدهای اصلی این مرور، پائین یا بسیار پائین بود، این نشان دهنده آن است که اعتماد ما به اندازه تاثیرگذاری گزارش شده، محدود یا بسیار محدود است، و این موضوع باید در تحقیقات آینده بهتر بررسی شود.
Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
JHJ: none.
MB: Boston Scientific (consultant for endourology and stone management), Auris Health (consultant for robotic surgery and endourology).
KAM: none.
SY: none.
JG: none.
MHK: none.
VN: none.
PD: none.
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References
References to studies included in this review
Abt 2021 {published data only}
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Abt 2019 {published data only}
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