Pudendal neuromodulation system shows promise for urinary incontinence

Preliminary data from the AURA-2 trial (NCT05241379) support the safety and feasibility of the Amber-UI therapy, a fully implantable, adaptive pudendal neuromodulation system for the treatment of patients with urinary incontinence (UI), according to a news release from Amber Therapeutics, the developer of the therapy.¹

In total, the first-in-human study recruited 13 patients with severe refractory urge UI or mixed UI.

Data from the first-in-human study were presented at the recent Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) annual meeting in Fort Lauderdale, Florida.²

“I am very excited to see these excellent preliminary results with Amber-UI in a very difficult-to-manage patient group with mixed urinary incontinence, and for whom no single therapy exists. With these data, Amber’s pioneering technology is demonstrating its promise to be a safe and scalable solution for patients that personalizes therapy to their needs and helps them regain control of their bladder and their lives. We look forward to completing the follow-up period with the remaining patients and presenting final data that we hope will further reinforce Amber-UI’s potential to have a meaningful impact for patients dealing with this common and debilitating condition,” said lead investigator Stefan De Wachter, MD, PhD, in the news release.¹ De Wachter is a professor of urology at Antwerp University and a co-founder of Amber Therapeutics.

Interim data from the study showed that at 6 months following implantation, 80% (4 of 5) of evaluable women with mixed UI experienced a complete resolution of incontinence episodes. Further, investigators observed clinically significant improvements in symptom-related quality-of-life among those patients with mixed and those with refractory urge UI.

The study also demonstrated clinical proof of principle evidence regarding the capabilities on the Amber-UI device. Acute stimulation of the device showed effects on both barrier muscle functions (sphincter and pelvic floor contraction and electromyography measurements) and on suppression of detrusor overactivity leading to increased mean cystometric bladder capacity. This was manifested as reductions in stress and urge incontinence events in patients with mixed UI. The utility of the device’s patient-controlled adaptive algorithms were also demonstrated through the ability of the device to detect relevant physiological biomarkers of pelvic neuromuscular activity in real-time in vivo.

At the SUFU annual meeting, data were presented on 2 female patients included in the AURA-2 study, one of whom had urge urinary incontinence (UUI) and the other with mixed UI.²

Overall, treatment with basal and adaptive stimulation was well-tolerated among both patients, and no adverse events were reported. Treatment during awake urodynamics led to increases in maximum cystometric capacity (MCC) with basal and adaptive stimulation modes from baseline in both patients. The patient with UUI demonstrated an MCC of 233 vs 265 vs 401 mL (180% baseline), and the patients with mixed UI demonstrated an MCC of 221 vs 416 vs 395 mL (188% baseline).

At last follow-up, both patients had reported complete resolution of their incontinence, from 3.6 and 4.2 episodes per day to 0. Additionally, both patients reported a score of 1 (very much better) on a global impression of improvement assessment.

In total, the first-in-human study recruited 13 patients with severe refractory urge UI or mixed UI. Patients were treated at the University Hospital Antwerp in Belgium, where they received a surgical procedure to implant 2 electrode leads on the pudendal nerve.

The primary outcome measure for the study is adverse events related to the device, measured at various time points following implantation. Secondary outcome measures include the number of patients successfully implanted, changes in voiding diary data, and measurements of electromyography.³

References:

1. Amber Therapeutics announces positive preliminary results from its first-in-human investigation of Amber-UI, its new adaptive implanted pudendal neuromodulation system for urinary incontinence. News release. Amber Therapeutics. Published online and accessed February 27, 2024. https://www.globenewswire.com/news-release/2024/02/27/2836113/0/en/Amber-Therapeutics-announces-positive-preliminary-results-from-its-first-in-human-investigation-of-Amber-UI-its-new-adaptive-implanted-pudendal-neuromodulation-system-for-urinary-i.html

2. Wachter SD, Herroelen S, Knowles C, et al. Elucidating the effect of adaptive pudendal nerve stimulation: Early report on two patients. Presented at the 2024 Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Annual Meeting. Fort Lauderdale, Florida. Abstract NM10

3. AURA-2: augmenting urinary reflex activity (AURA-2). ClinicalTrials.gov. Last updated December 6, 2022. Accessed February 27, 2024. https://clinicaltrials.gov/study/NCT05241379