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

• Published in: Urology (Ridgewood, N.J.) Vol. 202; pp. 58 - 65
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2025; Elsevier
• Subjects: Adult; Aged; Electric Stimulation Therapy - adverse effects; Electric Stimulation Therapy - instrumentation; Electric Stimulation Therapy - methods; Female; Follow-Up Studies; Humans; Implantable Neurostimulators - adverse effects; Intermittent Urethral Catheterization; Life Sciences; Male; Middle Aged; Time Factors; Treatment Outcome; Urinary Retention - therapy; Non-obstructive urinary retention; Clinical performance; interstim micro system
• ISSN: 0090-4295; 1527-9995; 1527-9995
• DOI: 10.1016/j.urology.2025.03.057

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.