Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6‐month results from the global postmarket ELITE study
Rattachement africain : us, fr, ca. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
AIMS: Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up. METHODS: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapy-related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. RESULTS: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3- and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow-up in UUI episodes/day was -3.6 (95% CI: -4.7, -2.6; n = 62) at 3-month and -3.7 (95% CI: -4.7, -2.7; n = 61) at 6-month. Among subjects with urgency-frequency (UF), the average change from baseline to follow up in voids/day was -4.5 (95% CI: -6.3, -2.7; n = 52) at 3-months and -4.4 (95% CI: -6.0, -2.7; n = 52) at 6-month. The cumulative incidence of device-, procedure-, or therapy- related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. CONCLUSIONS: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6‐month results from the global postmarket ELITE study
- Date Crossref
- 14/03/2023
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Ochsner Medical Center Department of Urology pays non établi dans la noticeÉtablissement de santé
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Urology Associates of North Texas pays non établi dans la noticeÉtablissement de santé
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Urology of Indiana pays non établi dans la noticeÉtablissement de santé
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Prisma Health pays non établi dans la noticeÉtablissement de santé
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Centre Hospitalier Universitaire de Nantes Department of Urology pays non établi dans la noticeÉtablissement de santé
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Nantes Université pays non établi dans la noticeUniversité ou école supérieure
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Louisiana State University Health Sciences Center New Orleans Department of Urology pays non établi dans la noticeÉtablissement de santé
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Metro Urology pays non établi dans la noticeÉtablissement de santé
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First Coast Cardiovascular Institute pays non établi dans la noticeÉtablissement de santé
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Centre Hospitalier Universitaire de Rennes Department of Urology pays non établi dans la noticeÉtablissement de santé
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West Virginia University Department of Urology pays non établi dans la noticeUniversité ou école supérieure
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Department of Urology — Ochsner Medical Center, Urology Associates of North Texas et Urology of Indiana, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.