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Updated: May 16, 2025
Autonomous and Rechargeable Microneurostimulator Endoscopically Implantable into the Submucosa
Published on: September 27, 2018
Post-Market Study Evaluating Performance of the Rechargeable InterStim™ Micro System in Fecal Incontinence Patients
Dean Elterman1, Margarita Murphy2,3, Ryan Krlin4
1Division of Urology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada. Dean.Elterman@uhn.ca.
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.
