Kevin Benson, MD, explains new Altaviva data for urgency urinary incontinence

Data from the TITAN 2 pivotal study (NCT05226286) presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) 2026 Winter Meeting indicated that an implantable tibial neuromodulation (ITNM) system provides durable relief for urgency urinary incontinence (UUI). Two poster presentations highlighted that the Altaviva (Medtronic) system maintained significant symptom reduction and high patient satisfaction over 24 months.

UUI is a common symptom of overactive bladder (OAB) associated with psychological and health risks; however, treatment adherence is historically low. By 2030, approximately 402 million adults worldwide will be living with OAB. Kevin Benson, MD, a urogynecologist at Sanford Health and study investigator, noted the study provides an opportunity for "a group of patients that might have had problems either tolerating or being eligible, frankly, for a sacral neuromodulation device."

TITAN 2 Study Design

The TITAN 2 study was a prospective, multi-center, single-arm trial conducted at 26 sites. A total of 126 participants were implanted with the Altaviva system. The primary endpoint was the UUI responder rate at 6 months, defined as at least a 50% reduction in UUI episodes per day.

Participants were required to have failed or been intolerant to conservative therapy and more than two pharmacological treatments. Benson emphasized that "these patients really reflect the real world. You might say they're not cherry-picked." Baseline characteristics included a mean of 7 years since diagnosis and 5.1 UUI episodes per day; 29% had failed prior advanced treatments like Botox or sacral neuromodulation.

Sustained Outcomes and Quality of Life

The Altaviva system maintained improvement throughout the 2-year follow-up, translating to approximately 2.5 to nearly 3 fewer leaks per day. "What we found was essentially that the results presented earlier in the 12-month data are sustained. We didn't see any drop-off in efficacy,” Benson told Contemporary OB/GYN.

Safety data showed cumulative adverse device effect rates of 17% at 6 months and 24% at 24 months. All effects were mild or moderate. Benson remarked it was "important" that data showed "no increase in adverse outcomes."

The OAB-q health-related QoL score improved by +26.9 at 6 months and remained sustained at +27.1 at 24 months. By 24 months, 80% of participants reported improvement and 71% reported satisfaction. Benson concluded that "over a 2-year period of time, it is a safe therapy that can be offered to patients without concerns that there are going to be major adverse issues."

To view more of the data, click here.

Editor’s note: Kevin Benson, MD, reported a disclosure to Medtronic.

Reference:

Fitch J. Altaviva system for UUI demonstrates sustained safety, efficacy, quality of life improvements through 24 months. Contemporary OB/GYN. Published March 3, 2026. Accessed March 3, 2026. https://www.contemporaryobgyn.net/view/altaviva-system-for-uui-demonstrates-sustained-safety-efficacy-quality-of-life-improvements-through-24-months