Liss Michael A, Morales Blanca, Skarecky Douglas, Ahlering Thomas E
Department of Urology, University of California , Irvine, Orange, California.
J Endourol. 2014 Oct;28(10):1241-5. doi: 10.1089/end.2014.0342. Epub 2014 Jul 21.
Permanent and prolonged incontinence following robot assisted radical prostatectomy (RARP) is known to result from injury to the external sphincter. We hypothesize that pre-existing detrusor overactivity may also contribute to delayed return of continence (>3 months). This pilot study examines the safety profile and efficacy of muscarinic receptor antagonist, solifenacin, in incontinent men after prostatectomy.
Men using three or more pads 7 days post catheter removal were invited to enroll into the study (5 mg daily of solifenacin for 3 months). All subjects received RARP under hypothermic conditions by one surgeon. Continence was defined as 0 pads.
Forty men were enrolled, one excluded due to missing follow-up. Two men reported nonserious adverse events: one a vaso-vagal reaction when taking solifenacin with sildenafil, and the other was dehydration and dizziness after strenuous exercise. Additionally, four withdrew due to side effects. The efficacy outcomes show improved intermittency after prostatectomy, though unclear if due to the medication. At 3 months, 21 patients (53.8%) reached the primary continence outcome of zero pads. The median time to continence in this group was 95 days.
Solifenacin is well tolerated in post radical prostatectomy patients with a 15% withdrawal rate due to side effects. These results formed the basis of a large, prospectively randomized clinical trial comparing the effects of solifenacin versus placebo in a population of men incontinent after RARP.
机器人辅助根治性前列腺切除术（RARP）后出现永久性和持续性尿失禁，已知是由外括约肌损伤所致。我们推测，术前存在的逼尿肌过度活动也可能导致控尿延迟恢复（超过3个月）。这项初步研究探讨了毒蕈碱受体拮抗剂索利那新在前列腺切除术后尿失禁男性患者中的安全性和疗效。
邀请在拔除导尿管7天后使用三块或更多尿垫的男性参加本研究（每日5毫克索利那新，持续3个月）。所有受试者均由一名外科医生在低温条件下进行RARP手术。控尿定义为使用0块尿垫。
40名男性入组，1名因失访被排除。两名男性报告了非严重不良事件：一名在服用索利那新与西地那非时出现血管迷走反应，另一名在剧烈运动后出现脱水和头晕。此外，有4人因副作用退出。疗效结果显示前列腺切除术后间歇性有所改善，但不清楚是否归因于药物。3个月时，21例患者（53.8%）达到了零尿垫的主要控尿结果。该组控尿的中位时间为95天。
索利那新在根治性前列腺切除术后患者中耐受性良好，因副作用导致的退出率为15%。这些结果构成了一项大型前瞻性随机临床试验的基础，该试验比较索利那新与安慰剂对RARP术后尿失禁男性人群的影响。
