SUFU: Altaviva system provides sustained improvements in UUI symptoms and QOL

Findings from the pivotal TITAN 2 trial (NCT05226286), shared at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) 2026 Winter Meeting, demonstrate that an implantable tibial neuromodulation (ITNM) system offers sustained benefit for urgency urinary incontinence (UUI). Two poster presentations reported that the Altaviva system delivered durable symptom improvement and high patient satisfaction through 24 months of follow-up.^1,2

Altaviva is a “small device is placed under the skin near the ankle [that] sends electrical pulses to the tibial nerve” in order to restore communication pathways between the brain and the bladder and thus help reduce bladder control symptoms.³ The device was approved in the US for the treatment of patients with UUI in September 2025.

Kevin Benson, MD, a urogynecologist at Sanford Health and an investigator in TITAN 2, explained that the study builds upon the earlier TITAN 1 feasibility trial and offers an alternative for “a group of patients that might have had problems either tolerating or being eligible, frankly, for a sacral neuromodulation device.”

Study design and methodology

TITAN 2 was designed as a prospective, multicenter, single-arm, nonrandomized study conducted across 26 sites.^1,2 A total of 126 patients underwent implantation with the Altaviva device, with outcomes assessed at 6, 12, and 24 months.¹ The primary end point was the UUI responder rate at 6 months, defined as a reduction of at least 50% in daily UUI episodes.¹

Enrollment criteria were rigorous, requiring prior failure of or intolerance to conservative management as well as more than 2 pharmacologic therapies.¹ Benson underscored 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.”

At baseline, participants had lived with UUI for a mean of 7 years and experienced an average of 5.1 UUI episodes per day.¹ Notably, 29% had previously failed advanced therapies such as intradetrusor onabotulinumtoxinA or sacral neuromodulation.¹

Clinical effectiveness and durability

The first poster highlighted effectiveness results through 24 months, demonstrating that symptom improvement was maintained over the full 2-year period.¹ On average, patients experienced approximately 2.5 to nearly 3 fewer leakage episodes 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 Urology Times®, adding that fewer daily episodes enable patients to “utilize the bathroom in a manner that is discreet and safe for them.”

He further noted that reducing overall voiding frequency allows patients to “free up to do those things and not negatively impact their quality of life,” whether in professional, academic, or personal settings.

Safety and procedural profile

Cumulative adverse device effect rates were 17% at 6 months and 24% at 24 months.¹ All device-related events were classified as mild or moderate, and no cases of device migration were reported.

Benson emphasized that it was “important” that the findings showed “no increase in adverse outcomes or any type of increased significant adverse events as it relates to safety.”

The implantation procedure is performed under local anesthesia, which Benson described as a “big thing” in terms of patient reassurance and comfort. He explained that the minimally invasive device is positioned above the ankle fascia.

“By not having a penetrator inside the fascia, the degree of safety is increased,” Benson said, noting that adverse events in that region were minimal and that only 1 device required explant.

Patient-reported outcomes

The second poster focused on patient-reported outcomes and quality of life measures.² The OAB-q health-related quality of life score improved by +26.9 at 6 months and remained stable at +27.1 at 24 months.

Benson indicated that these improvements reflect patients’ enhanced 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 24 months, 80% of participants reported overall improvement in their condition. Additionally, 71% indicated satisfaction with treatment at 2 years and said they would recommend the therapy to others.

Investigators concluded that the Altaviva ITNM system delivers sustained reductions in UUI symptoms along with meaningful quality of life improvements through 24 months of follow-up.^1,2 Benson summarized the clinical relevance 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
3. Altaviva System. Medtronic. Accessed March 3, 2026. https://www.medtronic.com/en-us/patients/conditions-treatments/urinary/altaviva-system.html