Introduction and Hypothesis <p>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.</p> Methods <p>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).</p> Results <p>Of 53 patients implanted, 90.6% were female and the mean (± SD) age was 58 ± 11&#xa0;years. There was a statistically significant improvement in CCIS at 3&#xa0;months vs baseline, with a mean change of −4 ± 3.7 (<i>p</i> &lt; 0.001, <i>n</i> = 52). This improvement was maintained at 6&#xa0;months, with a mean change of −4.0 ± 3.58 (<i>n</i> = 52). The mean change in Fecal Incontinence Quality of Life (FIQoL) at 3&#xa0;months was 3.2 ± 2.8 (<i>n</i> = 52) and 3.6 ± 2.9 (<i>n</i> = 53) at 6&#xa0;months. On the Patient Global Impression of Improvement (PGI-I), 94% (<i>n</i> = 52) and 90.6% (<i>n</i> = 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.</p> Conclusions <p>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.</p> <p>Clinical trial registration: NCT04506866.</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Post-Market Study Evaluating Performance of the Rechargeable InterStim™ Micro System in Fecal Incontinence Patients

  • Dean Elterman,
  • Margarita Murphy,
  • Ryan Krlin,
  • Rebecca Levine,
  • Jerome Yaklic,
  • Jodi Michaels,
  • Joshua Bleier,
  • Ian Paquette,
  • Russell Farmer,
  • Keith Xavier,
  • Bianca Papi,
  • Mariah Wu,
  • Laurent Siproudhis

摘要

Introduction and Hypothesis

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.

Methods

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).

Results

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.

Conclusions

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.

Clinical trial registration: NCT04506866.