Malde Sachin, Lavin Victoria, Perrouin-Verbe Marie-Aimée, Elterman Dean, Peyronnet Benoît, Smits Martijn, Shah Sagar, Xavier Keith, Krlin Ryan, Bukkapatnam Raviender, Papi Bianca, Champs Mylène, Goudelocke Colin, Sahai Arun
Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
The Newcastle Upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital, Newcastle, UK.
Urology. 2025 Aug;202:58-65. doi: 10.1016/j.urology.2025.03.057. Epub 2025 Apr 4.
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.
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.
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).
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.
