A Prospective Study to Evaluate Efficacy Using the Nuro™ Percutaneous Tibial Neuromodulation System in Drug-Naïve Patients with Overactive Bladder Syndrome

Overactive bladder (OAB) is a very prevalent condition that has a tremendous negative impact on the quality of life (QOL) of millions of people around the world. Accordingly, there has been increasing focus on how to best manage this bothersome constellation of symptoms that includes urinary frequency and urgency with or without incontinence. New OAB treatment modalities are at the forefront of the medical literature and discussions at every urologic and pelvic floor meeting. The AUA/SUFU OAB guidelines are constantly evolving, with the most recent update having been presented at the 2019 American Urological Association meeting in Chicago.

The guidelines present treatment options in a graded fashion indicated as 1^stthrough 4^th line therapies, that starts with conservative therapies and progresses through more invasive options. However, the updated guidelines include an important assertion that explicitly establishes that it is not necessary to proceed through each line of therapy before trying the next line. In other words, the guidelines are not meant to represent an algorithm, but rather guidance regarding available options for OAB management.

The RESET study evaluated percutaneous tibial nerve neuromodulation (PTNM), also known as percutaneous tibial nerve stimulation (PTNS), in the treatment of drug-naïve OAB patients. The importance of this study cannot be underestimated. Medications pose a huge financial burden on patients and the healthcare system. Additionally, recent studies suggesting the potential for some OAB medications to cause cognitive side effects ^1,2 in addition to bothersome dry mouth, dry eyes, and constipation have escalated the movement away from pharmacotherapy in some patients. Finally, and importantly, studies have demonstrated that up to 90% of patients have discontinued their medications by 6 months.³ While this may be due to any of the above factors, it also brings into question the efficacy of medications used to treat OAB.

To be eligible for the RESET study, patients had to be drug-naïve with a minimum of 3 urgency incontinence (UUI) episodes on a 3-day voiding diary. 96% of the 120 patients enrolled completed the study, with 107 completing a full 12 PTNM sessions. All parameters assessed revealed statistically significant and favorable outcomes. A decrease in UUI episodes/day and urinary frequency were statistically significant. Importantly, the degree of improvement in UUI/day increased as the patients progressed through 12 treatments, suggesting that patients should endeavor to complete all 12 treatments. These outcomes were mirrored in the health-related QOL assessment, which demonstrated a significant improvement overall and in subscales of the QOL tool. There were no serious adverse events.

This study is particularly relevant in today’s treatment of OAB and in light of the updated AUA/SUFU guidelines that suggest that drug-naïve patients can proceed straight to PTNM without first trying pharmacotherapy. Many patients wish to forego medication altogether, and with the high cost, bothersome side effects, and efficacy profile of medications in the face of a successful minimally invasive option such as PTNM, it is very reasonable to consider PTNM earlier in the treatment algorithm for OAB.

Written by: Kathleen Kobashi, MD, FACS, FPMRS, Urology, Virginia Mason Medical Center, Seatle, Washington, United States

References:
1. Richardson K et al.: Anticholinergic drugs and risk of dementia: case-control study. BMJ 2018;Apr 25 361:k:1315.
2. Coupland CAC et al.: Anticholinergic drug exposure and the risk of dementia: a nested case-control study. JAMA Intern Med 2019 Jun 24.
3. Veenboer PW and Bosch JL: Long term adherence to antimuscarinic therapy in everyday practice a systematic review. J Urol 2014;191(4):1003-8.

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