Trial reportInternational urogynecology journal2025
Post-Market Study Evaluating Performance of the Rechargeable InterStim™ Micro System in Fecal Incontinence Patients.
Trial report in International urogynecology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04506866 (Evaluation of InterStim Micro System Performance and Safety), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisTo confirm the performance and safety of the rechargeable sacral neuromodulation system (InterStim™ Micro) through 2-year follow-up, we report results from the fecal incontinence (FI) cohort through 6-month follow-up.
methodsEligible patients were enrolled following successful therapy evaluation and implant. Participants completed bowel diaries and questionnaires at baseline, 3, and 6 months post-implant. The primary objective was improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline. Safety was evaluated by collection of reportable adverse events (AE).
resultsOf 53 patients implanted, 90.6% were female and the mean (± SD) age was 58 ± 11 years. There was a statistically significant improvement in CCIS at 3 months vs baseline, with a mean change of -4 ± 3.7 (p < 0.001, n = 52). This improvement was maintained at 6 months, with a mean change of -4.0 ± 3.58 (n = 52). The mean change in Fecal Incontinence Quality of Life (FIQoL) at 3 months was 3.2 ± 2.8 (n = 52) and 3.6 ± 2.9 (n = 53) at 6 months. On the Patient Global Impression of Improvement (PGI-I), 94% (n = 52) and 90.6% (n = 53) of participants reported their condition was better at 3- and 6-month follow-up compared to baseline, respectively. The incidence of device-, procedure-, or therapy-related AEs in enrolled participants was 18.9% (10/53); among these was one serious related AE. There were no unanticipated adverse device effects.
conclusionsThe primary objective of the FI cohort was met, with statistically significant improvement in CCIS and patient-reported outcomes. These data confirm clinical performance and safety through 6 months post-implant. CLINICAL
trial registrationNCT04506866.
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