- Research Article
- 10.1007/s00192-025-06127-9
Post-Market Study Evaluating Performance of the Rechargeable InterStim™ Micro System in Fecal Incontinence Patients.
- Apr 01, 2025
- International urogynecology journal
- Dean Elterman + 12 more +12
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 ± 11years. There was a statistically significant improvement in CCIS at 3months vs baseline, with a mean change of -4 ± 3.7 (p < 0.001, n = 52). This improvement was maintained at 6months, with a mean change of -4.0 ± 3.58 (n = 52). The mean change in Fecal Incontinence Quality of Life (FIQoL) at 3months was 3.2 ± 2.8 (n = 52) and 3.6 ± 2.9 (n = 53) at 6months. 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.
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