Elterman Dean, Murphy Margarita, Krlin Ryan, Levine Rebecca, Yaklic Jerome, Michaels Jodi, Bleier Joshua, Paquette Ian, Farmer Russell, Xavier Keith, Papi Bianca, Wu Mariah, Siproudhis Laurent
Division of Urology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.
Colon Surgeons of Charleston, Mount Pleasant, SC, USA.
Int Urogynecol J. 2025 Apr;36(4):913-921. doi: 10.1007/s00192-025-06127-9. Epub 2025 Apr 5.
To confirm the performance and safety of the rechargeable sacral neuromodulation system (InterStim™ Micro) through 2-year follow-up, we report results from the fecal incontinence (FI) cohort through 6-month follow-up.
Eligible patients were enrolled following successful therapy evaluation and implant. Participants completed bowel diaries and questionnaires at baseline, 3, and 6 months post-implant. The primary objective was improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline. Safety was evaluated by collection of reportable adverse events (AE).
Of 53 patients implanted, 90.6% were female and the mean (± SD) age was 58 ± 11 years. There was a statistically significant improvement in CCIS at 3 months vs baseline, with a mean change of -4 ± 3.7 (p < 0.001, n = 52). This improvement was maintained at 6 months, with a mean change of -4.0 ± 3.58 (n = 52). The mean change in Fecal Incontinence Quality of Life (FIQoL) at 3 months was 3.2 ± 2.8 (n = 52) and 3.6 ± 2.9 (n = 53) at 6 months. On the Patient Global Impression of Improvement (PGI-I), 94% (n = 52) and 90.6% (n = 53) of participants reported their condition was better at 3- and 6-month follow-up compared to baseline, respectively. The incidence of device-, procedure-, or therapy-related AEs in enrolled participants was 18.9% (10/53); among these was one serious related AE. There were no unanticipated adverse device effects.
The primary objective of the FI cohort was met, with statistically significant improvement in CCIS and patient-reported outcomes. These data confirm clinical performance and safety through 6 months post-implant.
NCT04506866.
为通过2年随访确认可充电骶神经调节系统（InterStim™ Micro）的性能和安全性，我们报告了粪便失禁（FI）队列6个月随访的结果。
符合条件的患者在成功完成治疗评估和植入后入组。参与者在植入前、植入后3个月和6个月完成排便日记和问卷调查。主要目标是与基线相比，植入后3个月时克利夫兰诊所失禁评分（CCIS）有所改善。通过收集可报告的不良事件（AE）来评估安全性。
在53例植入患者中，90.6%为女性，平均（±标准差）年龄为58±11岁。与基线相比，3个月时CCIS有统计学显著改善，平均变化为-4±3.7（p<0.001，n = 52）。这种改善在6个月时得以维持，平均变化为-4.0±3.58（n = 52）。3个月时粪便失禁生活质量（FIQoL）的平均变化为3.2±2.8（n = 52），6个月时为3.6±2.9（n = 53）。在患者总体改善印象（PGI-I）方面，分别有94%（n = 52）和90.6%（n = 53）的参与者报告其病情在3个月和6个月随访时比基线更好。入组参与者中与设备、手术或治疗相关的不良事件发生率为18.9%（10/53）；其中有1例严重相关不良事件。没有出现意外的不良设备效应。
FI队列的主要目标得以实现，CCIS和患者报告的结果有统计学显著改善。这些数据证实了植入后6个月的临床性能和安全性。
NCT04506866。
