Background

Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time.

Objective

To compare UUI episodes (UUIE) over 24 mo following SNM or BTX.

Design, setting, and participants

Multicenter, open-label, randomized, extension trial (February 2012–July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX.

Intervention

SNM (n = 194) versus 200 U BTX (n = 192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed.

Outcome measurements and statistical analysis

Primary outcome: change in mean daily UUIE over 24 mo. Secondary outcomes: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model.

Results and limitations

Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (−3.88 vs −3.50 episodes/d,95% confidence interval [CI] = −0.14–0.89; p = 0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference = −9.14, 95% CI = −14.38–−3.90; p < 0.001), treatment endorsement (mean difference = −12.16, 95% CI = −17.7–−6.63; p < 0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p < 0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively.

Conclusions

Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions.

Patient summary

We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.

中文翻译：

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On神经调节性与OnabotulinumtoxinA联合治疗难治性尿急尿失禁的两年结果：一项随机试验。

背景

尿急尿失禁（UUI）是一种慢性疾病，condition神经调节（SNM）（InterStim / Medtronic）和肉毒杆菌毒素A（BTX）（BotoxA / Allergan）被利用。这些疗法尚未经过长时间的比较。

客观的

比较SNM或BTX之后24个月内的UUI情节（UUIE）。

设计，设置和参与者

在美国的9个医疗中心进行的多中心，开放标签，随机，扩展试验（2012年2月至2016年7月），涉及386名妇女在3天内UUIE≥6且药物治疗不足。参与者是治疗的临床反应者：SNM放置后或BTX后1个月UUIE降低≥50％。

干涉

SNM（n  = 194）与200 U BTX（n  = 192）。SNM重新编程在整个24个月内进行。6个月后，允许再注射两次BTX。

成果测量和统计分析

主要结果：超过24个月的平均每日UUIE发生变化。次要结果：无UUIE，UUIE降低≥75％和≥50％；膀胱过度活动症问卷简表；尿痛库存清单的缩写形式；失禁影响问卷；病人对改善的整体印象；膀胱过度活动症患者对治疗问卷的满意度；和不良事件（AE）。初步分析使用线性混合模型。

结果与局限性

可获得260/298（87％）位临床缓解者的结果数据。在24 mo内未发现平均UUIE降低的差异（−3.88 vs -3.50集/ d，95％置信区间[CI] = −0.14–0.89；p  = 0.15），UUI分辨率无差异，≥75％或减少UUIE≥50％。BTX组保持较高的满意度（平均差异= −9.14，95％CI = −14.38–-3.90；p  <0.001），治疗认可（平均差异= −12.16，95％CI = −17.7–−6.63；p  <0.001）至24 mo。其他辅助措施没有不同。BTX后复发性尿路感染（UTI）更高（24％比10％；p  <0.01），第二次注射后需要6％的间歇性导尿。SNM修订和清除分别发生在3％和9％的患者中。

结论

两种治疗方法均能持续改善UUI，BTX剂量较高时，干净的间歇性导管插入率较低，但存在UTI风险。由于标准化的导线放置以及严格的治疗反应定义，SNM修订/删除率很低。

病人总结

我们比较了一大批患有严重尿急性尿失禁（UUI）的美国妇女，这些妇女在2年期间接受了neuro神经调节（InterStim）或肉毒杆菌毒素A（肉毒杆菌A）治疗。我们发现，两种疗法在减轻UUI症状方面均具有相似的成功，且不良事件较少。但是，肉毒杆菌毒素治疗组中的妇女对治疗的满意度和认可度较高，但发生尿路感染的机会较高。我们得出的结论是，两种疗法均可在2年内持续降低每日尿失禁的发生率。