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Published on: January 10, 2013
Clinical Performance and Safety for the Rechargeable InterStim Micro System in Non-Obstructive Urinary Retention
Sachin Malde1, Victoria Lavin2, Marie-Aimée Perrouin-Verbe3
1Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
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.
