Altaviva system for UUI demonstrates sustained safety, efficacy, quality of life improvements through 24 months

New 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 separate poster presentations highlighted that the Altaviva (Medtronic) system maintained significant symptom reduction and high levels of patient satisfaction over a 24-month follow-up period.^1,2

Altaviva is approved in the United States for use, indicated only for UUI.

UUI is a common symptom of overactive bladder (OAB) associated with psychological and health risks; however, treatment adherence is historically low.¹ By 2030, approximately 402 million adults worldwide will be living with OAB, according to the study authors.

Kevin Benson, MD, a urogynecologist at Sanford Health and investigator for the TITAN 2 pivotal study, noted that the study represents an extension of the TITAN 1 feasibility work and 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 of Altaviva for UUI

The TITAN 2 study was a prospective, multi-center, single-arm, non-randomized trial conducted at 26 sites.^1,2 A total of 126 participants were implanted with the Altaviva system, with data reported at 6, 12, and 24 months.¹ The primary endpoint was the UUI responder rate at 6 months, defined as at least a 50% reduction in UUI episodes per day.¹

The study utilized stringent enrollment criteria, requiring participants to have failed or been intolerant to conservative therapy and more than 2 pharmacological treatments.¹ Benson emphasized that "these patients really reflect the real world. You might say they're not cherry-picked. They're not patients who may have a lower threshold to response."

The cohort’s baseline characteristics included a mean of 7 years since UUI diagnosis and a mean of 5.1 UUI episodes per day.¹ Additionally, 29% of participants had failed prior advanced treatments, including Botox or sacral neuromodulation.¹

Altaviva’s sustained improved outcomes for UUI

The first poster presented at SUFU focused on effectiveness outcomes through 24 months, showing that the Altaviva system maintained improvement throughout the 2-year follow-up.¹ These outcomes translated to approximately 2.5 to nearly 3 fewer leaks per day.¹

"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, noting that the reduction in daily episodes allows patients to "utilize the bathroom in a manner that is discreet and safe for them." He explained that by reducing the total number of voids, patients are "free up to do those things and not negatively impact their quality of life," whether at work, school, or enjoying other activities.

Safety data showed cumulative adverse device effect rates of 17% at 6 months and 24% at 24 months.¹ All reported adverse effects were mild or moderate, with no reported instances of device migration. Benson remarked that it was "important" that the data showed "no increase in adverse outcomes or any type of increased significant adverse events as it relates to safety."

The procedure itself is performed under local anesthetic, which Benson identified as a "big thing" for patient security and comfort. He described the minimally invasive nature of the device, noting it lies above the fascia in the ankle. "By not having a penetrator inside the fascia, the degree of safety is increased," Benson said, adding that "the adverse outcomes that were seen in that area were minimal and that only 1 device required explant."

Altaviva and improved quality of life in patients

The second poster evaluated patient-reported outcomes (PROs) and quality of life (QoL).² The OAB-q health-related QoL score improved by +26.9 at 6 months and remained sustained at +27.1 at 24 months. Benson noted that these metrics reflect the patients' ability "to make it to the bathroom and reducing the total number of voids, and to improve their ability to handle their bladder symptoms."

By the 24-month mark, 80% of participants reported improvement in their condition, with 71% reporting satisfaction at 24 months and that they would recommend treatment.

Related to women’s health specifically, Benson said Altaviva could help women experiencing urinary issues associated with menopause.

“As it relates to utilizing it in that venue, certainly this idea of women experiencing genitourinary syndrome of menopause, patients who have a lot of what are called LUTS, or lower urinary tract symptoms, ties completely into that arena and into that service line that you have, [as] these are patients who may be suffering with other things, but a component is definitely overactive bladder,” he said. “This is a therapy for those people who are active, who are otherwise seeking care for those other symptoms, but have a significant burden with this, could be helped, and this may tie in and dovetail well with therapies that are being offered for that problem.”

The investigators concluded that the Altaviva ITNM system provides sustained improvements in UUI symptoms and quality of life through 24 months of follow-up.^1,2 Benson summarized the clinical impact by stating 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."

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

References:

1. Benson K, Krlin R, Vollstedt A, et al. Safety and efficacy of an implantable tibial neuromodulation system for urgency urinary incontinence at 6, 12, and 24 months. Poster. Presented at: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting. February 25-28, 2026. San Juan, Puerto Rico.
2. Giusto L, Carey J, MacDiarmid S, et al. Patient-reported outcomes resulting from urgency urinary incontinence treatment using a implantable tibial neuromodulation system. Poster. Presented at: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting. February 25-28, 2026. San Juan, Puerto Rico.