Randomized, Sham-Controlled, Double-Blind Trial of the Intibia System in Urge Urinary Incontinence: Quality-of-Life Outcomes.

INTRODUCTION AND HYPOTHESIS: Urgency 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.

METHODS

The 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.

RESULTS

At 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.

CONCLUSIONS

The 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.