Clinical Performance and Safety for the Rechargeable InterStim Micro System in Non-Obstructive Urinary Retention...

Area of Science:

• Urology
• Neurology
• Medical Devices

Background:

• Non-obstructive urinary retention (NOUR) presents a significant challenge in urological care.
• Sacral neuromodulation (SNM) offers a therapeutic option for bladder dysfunction.
• The rechargeable InterStim Micro system is a novel SNM device.

Purpose of the Study:

• To evaluate the clinical performance and safety of the InterStim Micro SNM system in patients with NOUR.
• To report initial findings from the global ELITE study for the NOUR cohort.
• To assess outcomes at 6 months post-implantation.

Main Methods:

• Subjects with NOUR underwent successful therapy evaluation and implantation of the InterStim Micro neurostimulator.
• The primary endpoint was the reduction in daily clean intermittent self-catheterizations (CISC) at 3 months compared to baseline.
• Secondary endpoints included changes in post-void residual volume and patient-reported outcomes.

Main Results:

• A statistically significant reduction in daily CISC was observed at 3 months (-3.5, P < .001) and sustained at 6 months (-3.5).
• Significant reductions in post-void residual volume were noted at 3 months (-244 mL) and 6 months (-264 mL).
• High patient satisfaction was reported, with 88% and 79% experiencing improvement at 3 and 6 months, respectively. Adverse events were generally mild and related to the device or procedure.

Conclusions:

• The InterStim Micro system demonstrates significant efficacy in reducing CISC and post-void residual in patients with NOUR.
• The system shows a favorable safety profile through 6 months of follow-up.
• These findings support the use of InterStim Micro as an effective treatment option for NOUR.