Clinical Performance and Safety for the Rechargeable InterStim Micro System in Non-Obstructive Urinary Retention Subjects: 6-Month Results From the Global Post-Market ELITE Study

Objective

To confirm the clinical performance and safety of the rechargeable InterStim Micro sacral neuromodulation system, we report the first results from the global ELITE study for the non-obstructive urinary retention cohort through 6 months of follow-up.

Methods

Subjects were enrolled following successful therapy evaluation and neurostimulator implant. The primary objective was improvement in the number of clean intermittent self-catheterizations (CISC) per day at 3-months post-implant compared to baseline.

Results

The change in the number of CISC per day from baseline was −3.5 (95% CI: −4.77, −2.26; n = 23) at the 3-month follow-up, which was statistically significant (P <.001) and signifies that the primary objective was met. This change was sustained at 6-month follow-up, with a change of −3.5 (95% CI: −4.73, −2.29; n = 24). There was a reduction in post-void residual of 244 mL (95% CI: −334.6, −154; n = 22) at 3 months and 264 mL (95% CI: −366.43, −161.56; n = 21) at 6 months vs baseline. On the Patient Global Impression of Improvement, 88% and 79% of subjects reported that their bladder condition was better at 3 and 6 months, respectively, compared to before they were treated with InterStim Micro. Device-, procedure-, or therapy-related AEs included implant site pain (11.1%; 3/27), medical device site discomfort (7.4%; 2/27), and pain in extremity (7.4%; 2/27).

Conclusion

This study reports on the non-obstructive urinary retention population of the global ELITE study, demonstrating the efficacy and safety of the InterStim Micro system through 6 months of follow-up.