Bretschneider C Emi, Sheyn David, Lanki Nicola, Volpe Lena, Gupta Ankita
Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Division of Female Pelvic Medicine and Reconstructive Surgery, Urology Institute, University Hospitals, Cleveland, OH, USA.
Int Urogynecol J. 2024 Dec;35(12):2349-2355. doi: 10.1007/s00192-024-05891-4. Epub 2024 Aug 12.
The objective was to describe long-term device-related reoperations at 8 years following sacral neuromodulation (SNM) in women older than 65 years for the indications of overactive bladder (OAB), fecal incontinence (FI), and/or idiopathic urinary retention (UR).
The 2010-2019 Medicare 100% Outpatient Limited Dataset was used to identify women aged 65 years and older who underwent SNM to treat OAB, FI, and/or UR. The primary study outcome was any device-related reoperation within 8 years following initial implantable pulse generator (IPG) implantation defined as: IPG revision or removal; IPG replacement; or neuro-electrode revision or removal. Kaplan-Meier survival analysis was also performed to evaluate time to adverse event.
The cohort included 32,454 women with a mean age of 74 years. The most common indication for SNM was OAB (71%) followed by UI and FI (13%) and FI only (8%). Staged SNM procedures were performed more frequently (60%) than percutaneous nerve evaluation/full implants. The overall rate of device-related reoperations was 24% over 8 years: 12% of patients underwent removal or revision of the neuro-electrode, 11% underwent removal or revision of the IPG, and 13% underwent replacement of the IPG. The mean follow-up was 3.9 ± 2.4 years. The cumulative incidence of any device-related reoperations was 9.4% at 1 year, 20% at 3 years, and 43% at 8 years.
In the 8 years following SNM implantation, the rate of device-related reoperation among female Medicare beneficiaries was 43%, and staged implants were associated with a 17% lower likelihood of undergoing any device-related reoperations.
目的是描述65岁以上女性因膀胱过度活动症（OAB）、大便失禁（FI）和/或特发性尿潴留（UR）接受骶神经调节（SNM）8年后与装置相关的长期再次手术情况。
使用2010 - 2019年医疗保险100%门诊有限数据集，以识别65岁及以上接受SNM治疗OAB、FI和/或UR的女性。主要研究结局是首次植入可植入脉冲发生器（IPG）后8年内任何与装置相关的再次手术，定义为：IPG翻修或移除；IPG更换；或神经电极翻修或移除。还进行了Kaplan - Meier生存分析以评估不良事件发生时间。
该队列包括32454名女性，平均年龄74岁。SNM最常见的适应证是OAB（71%），其次是尿失禁和FI（13%）以及仅FI（8%）。分期SNM手术比经皮神经评估/完全植入更频繁（60%）。8年内与装置相关的再次手术总体发生率为24%：12%的患者接受了神经电极的移除或翻修，11%接受了IPG的移除或翻修，13%接受了IPG的更换。平均随访时间为3.9±2.4年。任何与装置相关的再次手术的累积发生率在1年时为9.4%，3年时为20%，8年时为43%。
在SNM植入后的8年中，女性医疗保险受益人与装置相关的再次手术率为43%，分期植入与任何与装置相关的再次手术的可能性降低17%相关。
