Flynn Michael K, Amundsen Cindy L, Perevich MaryAnn, Liu Fan, Webster George D
Division of Urogynecology, Department of Obstetrics and Gynecology, University of Rochester, Rochester, New York, USA.
J Urol. 2009 Jun;181(6):2608-15. doi: 10.1016/j.juro.2009.01.117. Epub 2009 Apr 16.
We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder.
Subjects were recruited from the Division of Urogynecology at the University of Rochester. Inclusion criteria were overactive bladder refractory to anticholinergic medications, multiple daily incontinence episodes and a 24-hour pad weight of 100 gm or greater. Subjects with low leak point pressures, increased post-void residual volume or neurological etiologies were excluded from study. Subjects were randomized to placebo or to 1 of 2 doses of botulinum-A toxin. The detrusor was injected at 8 to 10 sites above the trigone. Evaluations were performed at baseline, and at 3 and 6 weeks after injection, and included bladder diaries, pad weights, quality of life questionnaires and urodynamic studies.
A total of 22 subjects participated in stage 1 of this 2-stage study. We report on the outcomes of stage 1 of this study. Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin, the 2 botulinum-A toxin groups were combined for this report. There were no differences in mean baseline measurements between the 2 groups. Statistically significant improvements in daily incontinence episodes, pads changed per day and quality of life questionnaires were seen in the botulinum-A toxin group with no changes in the placebo group. No change in nocturia, daily voiding frequency, peak flow or detrusor pressure was seen in either group. Of 15 subjects 4 (26%) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization. Four subjects experienced a urinary tract infection, 2 (13%) in the botulinum-A toxin group and 2 (28%) in the placebo group (not significant).
Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks. However, there is a risk of urinary retention requiring self-catheterization.
我们比较了膀胱镜下注射肉毒杆菌A毒素与安慰剂治疗特发性膀胱过度活动症患者尿失禁的有效性。
受试者从罗切斯特大学泌尿妇科招募。纳入标准为对抗胆碱能药物难治的膀胱过度活动症、每日多次尿失禁发作且24小时尿垫重量达100克或以上。低漏点压力、排尿后残余尿量增加或有神经病因的受试者被排除在研究之外。受试者被随机分为安慰剂组或两种剂量肉毒杆菌A毒素中的一组。在膀胱三角上方8至10个部位注射逼尿肌。在基线、注射后3周和6周进行评估，包括膀胱日记、尿垫重量、生活质量问卷和尿动力学研究。
共有22名受试者参与了这项两阶段研究的第一阶段。我们报告本研究第一阶段的结果。由于第二阶段仍在进行中且研究人员对肉毒杆菌A毒素的剂量仍不知情，本报告将两个肉毒杆菌A毒素组合并。两组之间的平均基线测量值无差异。肉毒杆菌A毒素组每日尿失禁发作次数、每日更换尿垫数和生活质量问卷有统计学意义的改善，而安慰剂组无变化。两组夜尿、每日排尿频率、最大尿流率或逼尿肌压力均无变化。15名接受肉毒杆菌A毒素治疗的受试者中有4名（26%）排尿后残余尿量达200毫升或以上，1名受试者需要间歇性导尿。4名受试者发生尿路感染，肉毒杆菌A毒素组2名（13%），安慰剂组2名（28%）（无统计学意义）。
肉毒杆菌A毒素在6周时可显著减少膀胱过度活动症所致的急迫性尿失禁。然而，存在需要自我导尿的尿潴留风险。
