The Intibia™ system improves quality of life (QoL) outcomes beyond the placebo effect among patients with urgency urinary incontinence (UUI). Catherine A. Matthews, MD, of Wake Forest Baptist School of Medicine, Winston-Salem, NC, reported pivotal trial findings at the American Urological Association (AUA) annual meeting in Washington, DC.

The Intibia™ system is an implantable tibial nerve stimulator (ITNS) comprising a miniaturized pulse generator subcutaneously inserted below the fascia, adjacent to the tibial nerve near the ankle. The system has a long-lasting, non-rechargeable battery and delivers an automated stimulation (ultimately 30 minutes weekly) that can be tailored to the patient’s preferences, programmed remotely.

In the prospective, multicenter, randomized, double-blind, sham-controlled trial (Clinicaltrials.gov identifier: NCT05250908), the investigators randomly assigned patients (N=208) with UUI in a 2:1 ratio to receive implantation of an active (ITNS-ON; n=139) or sham (ITNS-SHAM; n=69) device.

In this presentation, the secondary outcomes of interest were the change in Patient Global Impression of Improvement (PGI-I) and Overactive Bladder Questionnaire (OABq) from baseline to 3 months. After 3 months, the study was unblinded and clinicians in the active treatment arm could reprogram the Intibia™ system to the patients’ preferred stimulation settings. Patients in the sham control arm could receive Intibia™ system stimulation at therapeutic levels. Patients were followed for 12 months after unblinding.

At baseline, the ITNS-ON and ITNS-SHAM groups experienced 4.3±2.7 and 4.5±2.9 UUI episodes per day. Patients were aged a mean 64 and 65 years, with an obese BMI of 32 and 32 kg/m2, 95.7% and 82.6% were White (P =.0016), respectively.

More than half of patients who received ITNS-ON reported an improvement in PGI-I at month 3 (57.7%) compared with approximately one-third of individuals who received ITNS-SHAM (31.3%; P <.01).

Similarly, the improvement in OABq symptom bother (mean difference [MD], -18.5 vs -10.2; P =.0068) and health-related QoL (HRQoL; MD, 17.2 vs 7.2; P =.0007) from baseline to month 3 was significantly greater with ITNS-ON than with ITNS-SHAM, respectively.

At the 12-month follow-up, the patients in the ITNS-ON group reported an even greater increase in PGI-I improvement (83.0%), OABq symptom bother (MD, -25.6), and OABq HRQoL (MD, 24.6) outcomes. At 12 months, 72% to 74% of patients met the threshold for the minimal clinically important difference in the OABq outcomes.

Dr Matthews concluded, “It’s an honor to present the first and only double-blind sham-controlled pivotal trial for ITNS in the United States. We see this really important improvement in quality of life, which is what our OAB patients care about. It seems that they are frustrated in collecting bladder diaries, and they really just want to know, ‘Am I going to feel better?’ We see that across multiple domains, there were meaningful [differences] over the sham group at 3 months. With sustained improvement at 12 months, the therapy was efficacious.”

The Intibia device is currently being reviewed by the US FDA.