ArticleInternational urogynecology journal2026
Randomized, Sham-Controlled, Double-Blind Trial of the Intibia System in Urge Urinary Incontinence: Quality-of-Life Outcomes.
Article in International urogynecology journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introduction and hypothesisUrgency urinary incontinence (UUI) is associated with significant impairments to quality of life (QoL) and overall social well-being. The aim of this analysis was to assess the impact of the Intibia System implantable tibial nerve stimulation (ITNS) device on QoL in patients with UUI and compare with a sham control.
methodsThe Intibia Pivotal Study was a prospective, randomized, sham-controlled, double-blind trial across the USA and the Netherlands. A total of 208 subjects were randomized to either an ITNS treatment group (ITNS-ON, n = 139) or a sham control group (ITNS-SHAM, n = 69). ITNS-SHAM subjects crossed over after 3 months. Disease-specific questionnaires regarding QoL and patient-reported outcomes were used to assess the impact of the Intibia System at 3, 6, and 12 months post-implant.
resultsAt 3 months, significantly more ITNS-ON subjects reported feeling "much better" or "very much better" than ITNS-SHAM subjects (29.2% vs 13.4%, p = 0.0133); ITNS-ON subjects also exceeded the minimally clinically important difference (MCID) at a higher rate than the ITNS-SHAM group for the Overactive Bladder Questionnaire Short Form Symptom Bother (62.8% vs 41.8%; p = 0.0046) and Health-Related Quality of Life sub-scales (57.4% vs 42.4%; p = 0.0463). At 12 months, 83% of ITNS-ON subjects reported any level of improvement compared with baseline. Significant improvements within the ITNS-ON group were observed in the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form over 12 months, with 71.5% of subjects exceeding the MCID.
conclusionsThe Intibia System demonstrated statistically and clinically meaningful improvements in self-reported, disease-specific QoL measures in patients with UUI compared with sham at 3 months and compared with baseline at 12 months.
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