When first line therapies such as behavioral therapy for overactive bladder (OAB) are unsuccessful, the American Urological Association guidelines recommend the use of anticholinergics (oral or transdermal medications) or β3-adrenoceptor agonists, as second line therapies. However, studies have shown that over a 12-month period, both β3-adrenoceptor agonists and anticholinergics have relatively high discontinuation rates (67% and 84%, respectively).[1] A recent systematic review observed an association between the cumulative use of anticholinergic medications and increased risk for cognitive impairment.[2] 

For patients inadequately managed with second line pharmacotherapies, third line treatment options are available such as onabotulinumtoxinA, sacral nerve stimulation, and percutaneous tibial nerve stimulation, all of which show high success rates. 

Despite high discontinuation rates with second line therapies, and high success rates with third line treatment options, the progression to third line therapy was reported to be less than 5% overall with rates rising to 10% in the community urology practice setting.[3] This may be due to a variety of factors including a lack of understanding of options, fear of side effects, or desire to avoid invasive treatments. Engaging patients with individualized, patient-centered care that guides the understanding and access to available therapeutic options can optimize care and improve treatment continuation throughout the clinical care pathway. We hypothesized that utilization of a treatment navigator, defined as a health professional focused on individualized patient-centered care and assisting in the guidance of the patient through the OAB clinical pathway, will lead to a higher utilization rate of third line therapies, such as onabotulinumtoxinA, and improve treatment continuation rates.

The primary objective of this study was to describe and compare the rate of patients progressing to onabotulinumtoxinA as a third line OAB treatment and continuing treatment with and without a treatment navigator, with a secondary aim of describing practice characteristics.

Adult patients diagnosed and treated for non-neurogenic OAB between January 1, 2015 and December 31, 2019 were retrospectively identified using ICD-9, ICD-10 and procedure codes from the Precision Point Specialty Analytics Portal for OAB. This database contains the electronic medical record data for over 90 community-based urology practices in the US that provide care to over 2.4 million OAB patients. 

Patients with a minimum of two OAB medical visits, occurring at least 30 days apart were considered for inclusion. Patients were excluded if they had OAB symptoms associated with a neurological condition or had a history of chronic urinary retention treated with intermittent catheterization or an indwelling catheter. A subset of eligible patients was randomly selected and stratified into navigation and non-navigation groups. The proportion of patients progressing to third line onabotulinumtoxinA, the proportion continuing onabotulinumtoxinA treatment, patient demographics and practice characteristics were assessed. Treatment continuation with onabotulinumtoxinA was defined as a patient returning for retreatment within 12-months of initial treatment and was assessed for patients with 12-months of follow-up data available (index date on or before December 31, 2018).

A total of 9,000 patients were randomly selected from the 170,000 patients who met all study inclusion criteria. This included 1,151 patients with care managed by a navigator and 7,849 patients without a navigator. Most patients receiving both navigated care (34.9%) and non-navigated care (35.1%) were from medium size practices, defined as having 11–25 providers (eg. urologists, nurse practitioners). Mean (±SD) age at diagnosis (index date) was 63.5 ± 16.9 years (64.0 ± 15.1 navigated, and 63.5 ± 17.2 non-navigated); 59.9% of patients were female who were more likely to receive navigated care (81.7% navigated vs. 56.7% non-navigated; p <0.001).

Third line therapy utilization results are summarized in Table 1. Of those patients receiving navigated patient-centered care, 24% advanced to a third line treatment compared with 11% without navigated care (odds ratio [95% CI]: 2.6 [2.20–2.99]; p <0.001). Patients receiving navigated care were also more likely to advance to onabotulinumtoxinA compared with the non-navigated cohort (10.5% and 5.1%, respectively, odds ratio [95% CI]: 2.2 [1.77–2.72]; p <0.001). Furthermore, the proportion of patients continuing onabotulinumtoxinA treatment significantly increased in patients receiving navigated patient-centered care versus the non-navigated cohort (59.4% vs 45.0%, respectively, odds ratio [95% CI]: 1.8 [1.02–3.15]; p = 0.042).

Navigated care is beneficial in OAB patients who do not respond to second line pharmacotherapy as it significantly improves both progression to third line therapy (odds ratio [95% CI]: 2.6 [2.20–2.99]; p < 0.001) and increases the proportion of patients continuing third line therapy with onabotulinumtoxinA (odds ratio [95% CI]: 1.8 [1.02–3.15]; p = 0.042) compared to patients without navigated care.

Utilization of a treatment navigator providing patient-centered care can help guide patients through the OAB clinical pathway, leading to increased utilization and continuation of third line treatment options such as onabotulinumtoxinA. Our results warrant further research to explore the impact navigated patient-centered care may have on patient satisfaction, quality of life outcomes and the need for further treatments.

Sussman D, Yehoshua A, Kowalski J, et al. Adherence and persistence of mirabegron and anticholinergic therapies in patients with overactive bladder: a real-world claims data analysis. Int J Clin Pract 2017; 71(3-4): e12824.
Pieper NT, Grossi CM, Chan W-Y, et al. Anticholinergic drugs and incident dementia, mild cognitive impairment and cognitive decline: a meta-analysis. Age and Aging 2020;49:939-47.
Moskowitz D, Adelstein S, Lucioni A et al. Use of Third Line Therapy for Overactive Bladder in a Practice with Multiple Subspecialty Providers-Are We Doing Enough? J Urol 2018; 199(3):779-784.