背景:间质性膀胱炎/膀胱疼痛综合征是一种与下尿路症状持续超过六周的膀胱相关的不愉快感觉,与其他可识别的原因无关。病因可能是多因素的,包括尿路上皮异常,神经源性疼痛上调,以及潜在的膀胱和阴道微生物组改变。尽管膀胱滴注和逼尿肌内注射对这种情况有效,尚未进行头对头比较。
目的:比较膀胱滴注与逼尿肌内注射脑钠毒素A治疗间质性膀胱炎/膀胱疼痛综合征的疗效。
方法:O'Leary-Sant(OLS)问卷得分≥6,符合间质性膀胱炎/膀胱疼痛综合征临床标准的患者,和期望的程序化管理被随机分配到膀胱滴注或逼尿肌内注射鼻烟毒素A。主要结果是组间治疗后2个月的OLS评分差异。次要结果包括评估性功能,身体/心理健康状况,疼痛,患者满意度,治疗感知,再治疗,和不良事件发生率。
结果:分析了47例患者,其中22例患者随机接受膀胱滴注,25例患者接受了单纯碱毒素A注射。两组之间的人口统计学和临床特征没有差异。从基线到治疗后2个月,所有患者的OLS量表均有下降(间质性膀胱炎症状指数(ICSI)-6.3(CI-8.54,-3.95),p<.0001;间质性膀胱炎问题指数(ICPI)-5.9(CI-8.18,-3.57),p<.0001)。治疗后2个月,与膀胱滴注组相比,onabotulinumtoxinA组的患者OLS评分显着降低(ICSI6.3±4.5[onabotulinumtoxinA]与9.6±4.2[滴注],p=.008;ICPI5.9±5.1[烟草素毒素A]与8.3±4.0[滴注],p=.048)。两组之间的OLS评分差异在治疗后6-9个月没有持续。其余问卷的基线和治疗后时间点之间没有统计学上的显着差异。8%的患者接受了甲胎素毒素A注射经历了需要自我导管插入的尿retention留。与接受膀胱滴注的患者相比,接受过甲脑毒素A注射的患者在6-9个月内接受再治疗的可能性显着降低(相对风险13.6;95%CI,1.92-96.6;P=.0002)。两组之间在患者满意度方面没有差异,感知治疗的便利性,或愿意接受治疗。
结论:单纯碱毒素A注射和膀胱滴注都是安全的,间质性膀胱炎/膀胱疼痛综合征患者的有效治疗方法,在治疗后2个月表现出显著的临床改善。我们的发现表明,与膀胱滴注疗法相比,逼尿肌肌内注射对这种情况是一种更有效的程序性治疗方法,并且与降低的再治疗率有关。
BACKGROUND: Interstitial cystitis (IC)/bladder pain syndrome (BPS) is an unpleasant sensation related to the bladder with lower urinary tract symptoms lasting more than 6 weeks, unrelated to an otherwise identifiable cause. The etiology is likely multifactorial including urothelial abnormalities, neurogenic pain upregulation, and potentially bladder and vaginal microbiome alterations. Despite treatment effectiveness of both bladder instillations and intradetrusor onabotulinumtoxinA injection for this condition, a head-to-head comparison has not been performed.
OBJECTIVE: To compare the efficacy of bladder instillations and intradetrusor onabotulinumtoxinA injection for treatment of IC/BPS.
METHODS: Patients with O\'Leary-Sant (OLS) questionnaire scores of ≥6, meeting clinical criteria for IC/BPS, and desiring procedural management were randomized to bladder instillations or intradetrusor onabotulinumtoxinA injection. The primary outcome was the difference in OLS scores at 2 months posttreatment between groups. Secondary outcomes included evaluation of sexual function, physical/mental health status, pain, patient satisfaction, treatment perception, retreatment, and adverse event rates.
RESULTS: Forty-seven patients were analyzed with 22 randomized to bladder instillations and 25 to onabotulinumtoxinA injection. There were no differences in demographic and clinical characteristics between groups. From baseline to 2 months posttreatment, there was a decrease in OLS subscales in all patients (Interstitial Cystitis Symptom Index [ICSI] -6.3 (confidence interval [CI] -8.54, -3.95), P<.0001; Interstitial Cystitis Problem Index [ICPI] -5.9 (CI -8.18, -3.57), P<.0001). At 2 months posttreatment, patients in the onabotulinumtoxinA group had significantly lower OLS scores compared to those in the bladder instillation group (ICSI 6.3±4.5 [onabotulinumtoxinA] vs 9.6±4.2 [instillation], P=.008; ICPI 5.9±5.1 [onabotulinumtoxinA] vs 8.3±4.0 [instillation], P=.048). The difference in OLS scores between groups did not persist at 6 to 9 months posttreatment. There were no statistically significant differences between baseline and posttreatment time points for the remaining questionnaires. Eight percent of patients who received onabotulinumtoxinA injection experienced urinary retention requiring self-catheterization. Patients who underwent onabotulinumtoxinA injection were significantly less likely to receive retreatment within 6 to 9 months compared to patients who received bladder instillations (relative risk 13.6; 95% CI, 1.92-96.6; P=.0002). There were no differences between groups regarding patient satisfaction, perception of treatment convenience, or willingness to undergo retreatment.
CONCLUSIONS: Both onabotulinumtoxinA injection and bladder instillations are safe, effective treatments for patients with IC/BPS, with significant clinical improvement demonstrated at 2 months posttreatment. Our findings suggest that intradetrusor onabotulinumtoxinA injection is a more effective procedural treatment for this condition than bladder instillation therapy and associated with decreased rates of retreatment.