PDF(Pubmed)
Abstract：
BACKGROUND: Prostate cancer (PCa) is the most common non-cutaneous malignancy in men and leads to the second most common cause of cancer related mortality in men. Early detection of PCa allows for a potentially curative intervention. Most men will live over a decade from the time of their PCa diagnosis. Thus, treatments must balance curative interventions with their impact on quality of life. Radical prostatectomy (RP) is one such potentially curative intervention but often leads to erectile dysfunction (ED) and urinary incontinence (UI). Approximately 90,000 RPs are performed each year in the USA. Post-operative ED and UI is thought to occur in part from traumatic peripheral nerve injury (TPNI) to the neurovascular bundles that surround the prostate. Thus, patients undergoing RP may be a population that would benefit from clinical studies that look at TPNI.
METHODS: The study is a single-institution, double-blinded placebo-controlled, randomized clinical trial in which patients immediately post-RP receive either 4-aminopyrdine (4AP) or placebo in a 1:1 fashion. The primary outcome is evaluation of the efficacy of 4AP in accelerating the early return of baseline erectile and urinary function post-radical prostatectomy.
CONCLUSIONS: This study is critical as it could reduce the morbidity associated with RP, a commonly performed operation, and identify a patient population that may greatly benefit into further TPNI research.
BACKGROUND: ClinicalTrials.gov NCT03701581. Prospectively registered on October 10, 2018.
METHODS: The study is a single-institution, double-blinded placebo-controlled, randomized clinical trial in which patients immediately post-RP receive either 4-aminopyrdine (4AP) or placebo in a 1:1 fashion. The primary outcome is evaluation of the efficacy of 4AP in accelerating the early return of baseline erectile and urinary function post-radical prostatectomy.
CONCLUSIONS: This study is critical as it could reduce the morbidity associated with RP, a commonly performed operation, and identify a patient population that may greatly benefit into further TPNI research.
BACKGROUND: ClinicalTrials.gov NCT03701581. Prospectively registered on October 10, 2018.
摘要：
背景：前列腺癌（PCa）是男性最常见的非皮肤恶性肿瘤，是导致男性癌症相关死亡的第二大常见原因。PCa的早期检测允许潜在的治愈性干预。大多数男性从他们的PCa诊断开始将活到十年以上。因此，治疗必须平衡治愈性干预措施及其对生活质量的影响。根治性前列腺切除术（RP）是一种潜在的治愈性干预措施，但通常会导致勃起功能障碍（ED）和尿失禁（UI）。在美国每年执行大约90,000个RP。术后ED和UI被认为部分发生于外伤性周围神经损伤(TPNI)至前列腺周围的神经血管束。因此，接受RP治疗的患者可能是受益于TPNI临床研究的人群.
方法：这项研究是一个单一的机构，双盲安慰剂对照,随机临床试验，患者在RP后立即接受4-氨基吡啶（4AP）或安慰剂，以1：1的方式。主要结果是评估4AP在前列腺癌根治术后加速基线勃起和排尿功能的早期恢复方面的疗效。
结论：这项研究至关重要，因为它可以降低与RP相关的发病率，通常执行的操作，并确定可能大大受益于进一步的TPNI研究的患者群体。
背景：ClinicalTrials.govNCT03701581。预计于2018年10月10日注册。
方法：这项研究是一个单一的机构，双盲安慰剂对照,随机临床试验，患者在RP后立即接受4-氨基吡啶（4AP）或安慰剂，以1：1的方式。主要结果是评估4AP在前列腺癌根治术后加速基线勃起和排尿功能的早期恢复方面的疗效。
结论：这项研究至关重要，因为它可以降低与RP相关的发病率，通常执行的操作，并确定可能大大受益于进一步的TPNI研究的患者群体。
背景：ClinicalTrials.govNCT03701581。预计于2018年10月10日注册。
