Research Center for Evidence-Based Medicine, Iranian EBM Center: A Joanna Briggs Institute Center of Excellence, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Midwifery, Bonab Branch, Islamic Azad University, Bonab, Iran.
Neurourol Urodyn. 2023 Aug;42(6):1329-1343. doi: 10.1002/nau.25224. Epub 2023 Jun 8.
We systematically assessed all available evidence on the efficacy and safety of sacral neuromodulation (SNM) in pregnancy.
On September 2022, a thorough search was done on Ovid, PubMed, Scopus, ProQuest, Web of Science, and The Cochrane Library. We chose studies that included pregnant women who had SNM previously. Two authors independently evaluated the quality of the study using a standardized tool of JBI. Studies were given a risk of bias rating of low, moderate, or high. Given the descriptive nature of this study, we utilized descriptive statistics to report demographic and clinical features. For continuous variables, we used mean and standard deviation, and for dichotomous data, we used frequencies and percentages.
Out of 991 abstracts screened, only 14 studies met our inclusion criteria and were included in the review. Overall, the quality of the evidence available from the literature is low based on the design of the included studies. Fifty-eight women, including 72 pregnancies, had SNM. The indication of SNM implantation was filling phase disorders in 18 cases (30.5%), voiding dysfunction in 35 women (59.3%), IC/BPS in two cases (3.5%), and fecal incontinence. In 38 pregnancies (58.5%), the SNM status was ON during pregnancy. Forty-nine cases delivered a full-term baby (75.4%), 12 cases had pre-term labor (18.5%), two miscarriages, and two postterm pregnancies happened. The most complications in patients with devices were urinary tract infection in 15 women (23.8%), urinary retention in six patients (9.5%), and pyelonephritis in two cases (3.2%). The findings revealed that when the device was deactivated, 11 cases out of the 23 patients (47.8%) had full-term pregnancies, while in ON status, 35 out of the 38 pregnant women (92.1%) had full-term pregnancies. Nine preterm labors in OFF (39.1%), and two in ON status (5.3%) were recorded. The results revealed that this difference was statistically significant (p = 0.002), and those who turned SNM of them off had more preterm labor. Although the studies reported all neonates had a healthy status, two children had chronic motor tic problems and a pilonidal sinus in a case with an active SNM in pregnancy. However, there was no association between the SNM status and pregnancy or neonatal complications (p = 0.057).
SNM activation in pregnancy seems safe and effective. The choice of whether to activate or deactivate SNM should be made on an individual basis given the current SNM evidence.
我们系统地评估了所有关于骶神经调节（SNM）在妊娠中的疗效和安全性的证据。
2022 年 9 月，我们在 Ovid、PubMed、Scopus、ProQuest、Web of Science 和 The Cochrane Library 上进行了全面检索。我们选择了先前接受过 SNM 的孕妇的研究。两位作者使用 JBI 的标准化工具独立评估研究质量。研究被评为低、中或高风险偏倚。鉴于本研究的描述性性质，我们使用描述性统计来报告人口统计学和临床特征。对于连续变量，我们使用平均值和标准差，对于二分类数据，我们使用频率和百分比。
在筛选出的 991 篇摘要中，只有 14 项研究符合我们的纳入标准，并被纳入综述。总体而言，根据纳入研究的设计，文献中可用证据的质量较低。58 名女性，包括 72 例妊娠，接受了 SNM。SNM 植入的指征是 18 例（30.5%）充盈期障碍、35 例（59.3%）排尿功能障碍、2 例（3.5%）IC/BPS 和粪便失禁。在 38 例妊娠中（58.5%），SNM 状态在妊娠期间处于开启状态。49 例足月分娩（75.4%），12 例早产（18.5%），2 例流产，2 例过期妊娠。在有设备的患者中，最常见的并发症是 15 名女性（23.8%）尿路感染、6 名患者（9.5%）尿潴留和 2 例肾盂肾炎。结果显示，当设备关闭时，23 名患者中有 11 名（47.8%）足月分娩，而在开启状态时，38 名孕妇中有 35 名（92.1%）足月分娩。9 例在关闭状态（39.1%）早产，2 例在开启状态（5.3%）早产。结果表明，这一差异具有统计学意义（p=0.002），关闭 SNM 的患者早产更多。尽管研究报告所有新生儿均健康，但在一名孕妇怀孕时 SNM 持续开启的情况下，有两名儿童患有慢性运动性抽动问题和皮隆尼尔窦。然而，SNM 状态与妊娠或新生儿并发症之间没有关联（p=0.057）。
妊娠期间激活 SNM 似乎是安全有效的。鉴于目前 SNM 的证据，应根据个体情况决定是激活还是关闭 SNM。
