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

Area of Science:

• Medical Devices
• Neuromodulation
• Gastroenterology

Background:

• Sacral neuromodulation is a treatment for fecal incontinence (FI).
• The InterStim™ Micro is a rechargeable sacral neuromodulation system.
• This study reports on the fecal incontinence cohort through 6-month follow-up.

Purpose of the Study:

• To confirm the performance and safety of the InterStim™ Micro system.
• To evaluate symptom improvement in patients with fecal incontinence.
• To assess patient-reported outcomes and adverse events.

Main Methods:

• Patients with fecal incontinence (FI) were enrolled after 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; safety was evaluated via adverse event collection.

Main Results:

• A statistically significant improvement in CCIS was observed at 3 months (mean change -4.0, p<0.001) and maintained at 6 months.
• Fecal Incontinence Quality of Life (FIQoL) scores also showed significant improvement at 3 and 6 months.
• 90.6% of participants reported improvement on the Patient Global Impression of Improvement (PGI-I) scale; 18.9% experienced related adverse events, with one serious event.

Conclusions:

• The InterStim™ Micro system met its primary objective, demonstrating statistically significant improvement in CCIS for fecal incontinence patients.
• Patient-reported outcomes, including quality of life, were significantly enhanced.
• The data confirm the clinical performance and safety of the rechargeable sacral neuromodulation system through 6 months post-implant.