Gynecologic Oncology Division and Urogynecology Division, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Int J Gynecol Cancer. 2011 May;21(4):730-6. doi: 10.1111/IGC.0b013e3181f7d6de.
Bethanechol chloride is considered as a treatment in patients with high postvoid residual urine (PVR). It enhances detrusor muscle contraction, resulting in higher maximum flow rate, higher detrusor pressure at maximum flow, and lower PVR. The efficacy of this agent in patients after radical hysterectomy is unclear. We aim to evaluate the efficacy of bethanechol chloride compared with placebo for the prevention of bladder dysfunction after type III radical hysterectomy.
Gynecologic cancer patients who underwent type III radical hysterectomy were randomized by computer-generated schedule to assign patients in a 1:1 ratio into 2 groups. The treatment group received bethanechol chloride (Ucholine 20 mg 3 times a day on the third to seventh postoperative day), and the control group received placebo. Patients and physicians were masked to treatment allocation. The primary end point was the rate of urethral catheter removal at 1 week postoperatively. If PVR was more than 30% of voided volume, the urethral catheter was reinserted, and medication would be continued but not for more than 1 month. This study was registered as ISRCTN92687416.
There were 31 patients in each group without significant difference in baseline characteristics. Twenty-one patients (67.7%) in the treatment group and 12 patients (38.7%) in the control group had the urethral catheter removed at 1 week postoperatively (P = 0.04). Median duration of urethral catheterization was shorter in the treatment group (7 and 14 days, P = 0.03). However, the PVR and the incidence of urinary tract infection at 1 month postoperatively were not significantly different. Nine patients (29%) in the treatment group had adverse events such as nausea, abdominal distension, and abdominal cramping, which was higher than the control group (1 patient, 3.2%; P = 0.01). However, no patients required any medical treatments.
Bethanechol chloride decreases the duration of urethral catheterization in patients who underwent type III radical hysterectomy with manageable adverse events.
氯化氨甲酰胆碱被认为是治疗高残余尿（PVR）患者的一种方法。它可以增强逼尿肌收缩，从而提高最大流率、最大流率时的逼尿肌压力，并降低 PVR。其在根治性子宫切除术患者中的疗效尚不清楚。我们旨在评估与安慰剂相比，氯化氨甲酰胆碱预防 III 型根治性子宫切除术后膀胱功能障碍的疗效。
接受 III 型根治性子宫切除术的妇科癌症患者通过计算机生成的时间表进行随机分组，以 1:1 的比例将患者分为两组。治疗组患者术后第 3 至 7 天接受氯化氨甲酰胆碱（Ucholine 20mg，每日 3 次）治疗，对照组患者接受安慰剂治疗。患者和医生对治疗分配均不知情。主要终点为术后 1 周时导尿管拔除率。如果残余尿量超过 30%，则重新插入导尿管，继续药物治疗，但不超过 1 个月。该研究在 ISRCTN 注册，注册号为 ISRCTN92687416。
两组患者的基线特征无显著差异，每组各 31 例。治疗组 21 例（67.7%）患者和对照组 12 例（38.7%）患者术后 1 周时拔除导尿管（P=0.04）。治疗组患者的导尿管留置时间中位数更短（7 天与 14 天，P=0.03）。然而，术后 1 个月时的残余尿量和尿路感染发生率无显著差异。治疗组 9 例（29%）患者出现恶心、腹胀和腹痛等不良反应，高于对照组（1 例，3.2%；P=0.01）。但无患者需要任何药物治疗。
氯化氨甲酰胆碱可缩短 III 型根治性子宫切除术患者的导尿管留置时间，但不良反应发生率较高。
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