Department of Urology, Medical School, Catholic University of Sacred Heart, Rome, Italy.
Neurourol Urodyn. 2018 Mar;37(3):1031-1038. doi: 10.1002/nau.23390. Epub 2017 Aug 25.
The injection of botulinum neurotoxin A (BTA) into the prostate represents a minimally invasive treatment in patients with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH). We evaluated the effectiveness of BTA in treating patients with BPH unresponsive to combined medical therapy (CMT), using urodynamic investigations.
This is a randomized, placebo-controlled, double blind trial. Twenty consecutive patients were randomly assigned to receive intraprostatic BTA injection (n = 10) or saline solution (SS) (n = 10). Patients in the intervention group (IG) received 200-300 UI of BTA diluted in 6-8 mL of SS and injected into the transitional zone. Patients in the control group (CG) were treated with SS alone. Primary endpoint was International Prostate Symptom Score (IPSS). Secondary endpoints were: maximum flow rate (Qmax), postvoid residual volume (PVR), maximum cystometric capacity (MCC), bladder outlet obstruction index (BOOI), safety, quality of life (QoL) score, and Patient Reported Outcome (PROs).
All patients in the IG reported subjective improvement starting after 1 month. At 3 months of follow-up IPSS, QoL, PVR were reduced by 55,3% (P < 0.01), and 50% (P < 0.01), 80,6%, (P < 0.01), respectively. Qmax was increased by 68% (P < 0.01). MCC increased by 27% (P < 0.01) and BOOI decreased by 54% (P < 0.01). PROs analysis revealed that 90% of patients in the IG reported a subjective symptomatic relief and treatment satisfaction. No local or systemic side effects were observed in any group.
These results indicated that intraprostatic BTA is safe and can improve LUTS and QoL in patients with BPH and unsatisfactory response to CMT.
在与良性前列腺增生（BPH）相关的下尿路症状（LUTS）患者中，将肉毒杆菌神经毒素 A（BTA）注射到前列腺中代表一种微创治疗方法。我们使用尿动力学研究评估了 BTA 治疗对联合药物治疗（CMT）无反应的 BPH 患者的有效性。
这是一项随机、安慰剂对照、双盲试验。连续 20 名患者被随机分配接受前列腺内 BTA 注射（n=10）或生理盐水溶液（SS）（n=10）。干预组（IG）患者接受 200-300 UI 的 BTA 稀释在 6-8 mL 的 SS 中，并注射到移行区。对照组（CG）患者单独接受 SS 治疗。主要终点是国际前列腺症状评分（IPSS）。次要终点是：最大尿流率（Qmax）、剩余尿量（PVR）、最大膀胱容量（MCC）、膀胱出口梗阻指数（BOOI）、安全性、生活质量（QoL）评分和患者报告的结果（PROs）。
IG 中的所有患者在 1 个月后开始报告主观改善。在 3 个月的随访中，IPSS、QoL、PVR 分别降低了 55.3%（P<0.01）、50%（P<0.01）和 80.6%（P<0.01）。Qmax 增加了 68%（P<0.01）。MCC 增加了 27%（P<0.01），BOOI 降低了 54%（P<0.01）。PROs 分析显示，IG 中 90%的患者报告了主观症状缓解和治疗满意度。两组均未观察到局部或全身副作用。
这些结果表明，前列腺内 BTA 是安全的，可以改善对 CMT 反应不佳的 BPH 患者的 LUTS 和 QoL。
