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蕭子玄 以InterStim系統進行膀胱過動症之薦骨神經調節(SNM):SOUNDS 法國前瞻性多中心觀察性研究 2021/9/1 下午 04:23:04
原 文 題  目 Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS
作  者 Chartier-Kastlera E, Normand LL, Ruffion A, et al.
出  處 European Urology Focus (2021) in-press
出版日期 in-press (Accepted June 29, 2021)
評 論

膀胱過動症的後線治療一直是許多難治患者的一線希望。神經調節的觀念已存在多年,但一直難以廣泛應用於膀胱過動症之治療。SOUNDS 的研究結果提供以InterStim系統進行膀胱過動症SNM之實證醫學基礎,對於此療法之推廣應有助益。

研究的主要參數為排尿日記效果、生活品質及疾病嚴重度等。追蹤時間為33.7月。共有190患者完成研究,其中包括初次使用及再次植入的患者。初次使用的患者有72%於第四次追蹤時表達治療有效,然而併發症率達49%,再次手術者有33%,而永久移除率達13%。此研究顯示InterStim系統對膀胱過動症之療效具統計意義,而且安全性在可接受範圍。

針對台灣醫療現況,推廣上會碰到若干問題。一、價格極高,一般患者就算有高額實支實付保險可能也難以負擔。二、因為價格極高,縱使療效具統計意義,主觀失敗率還有三成,而這種不確定性對醫師或患者都是相當大的壓力。三、手術部位非泌尿科醫師熟悉的身體部位,可能會降低泌尿科醫師嘗試或學習之動機。若價格能調降,而且醫師陸續有機會接受訓練,InterStim系統於膀胱過動症的後線治療應能佔一席之地。

abstract

Objective: To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation.

Design setting, and participants: Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 mo.

Outcome measurements and statistical analysis: The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test.

Results and limitations: Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4mo

Conclusions: This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life.

Patient summary: Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder.

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