Overactive Bladder Therapy: Patient Desire For Implantable Tibial Nerve Stimulator
Overview
Third-tier treatments for overactive bladder (OAB) presently encompass intravesical Onabotulinumtoxin-A injections (BTX-A), percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM). A recent addition to this array is the implantable tibial nerve stimulator (ITNS), offering a novel therapeutic avenue for OAB patients without neurogenic complications.
This investigation aimed to scrutinize alterations in patient inclinations toward third-tier OAB therapies following the introduction of ITNS alongside established options for non-neurogenic OAB.
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To fulfill this objective, a survey was meticulously crafted and disseminated via the SurveyMonkey platform to a demography comprising U.S. adults aged 18 years and above. Screening queries were meticulously formulated to select individuals exhibiting symptoms of OAB. Comprehensive elucidations of prevailing third-tier therapies sanctioned by the AUA/SUFU guidelines (BTX-A, PTNS, and SNM) were provided, prompting participants to prioritize these treatments (stage A). Subsequently, ITNS was introduced, accompanied by a detailed description, prompting respondents to reassess their preferences among the existing guideline-endorsed therapies and ITNS (stage B). Absolute and relative variations in therapy preferences from stage A to stage B were meticulously computed. Furthermore, correlations between the ultimate therapy selection in stage B and participant characteristics were rigorously examined.
Introduction
Overactive bladder (OAB) stands as a prevalent condition, afflicting 7%–27% of men and 9%–43% of women according to population-based studies. The impact of OAB extends significantly across various dimensions of patients’ quality of life and is correlated with heightened morbidity. Guided by the directives of the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), non-neurogenic OAB management is delineated into first-line behavioral interventions, second-line pharmacologic interventions, and third-line procedural interventions.
Third-tier interventions encompass intradetrusor Onabotulinumtoxin-A injections (BTX-A), sacral neuromodulation (SNM), and posterior tibial nerve stimulation (PTNS). While payer policies often stipulate a sequential trial of these therapies, guideline mandates do not necessitate such a stepwise approach. Third-line therapies may be offered interchangeably, with an alternative option presented if one proves ineffective.
Recent advancements in neuromodulation for OAB have given rise to implantable tibial nerve stimulators (ITNS), yet their incorporation into guidelines for non-neurogenic OAB remains pending, given the limited evaluation of their long-term efficacy exceeding three years.
While individual studies showcase the efficacy of BTX-A, PTNS, and SNM compared to placebos, comprehensive head-to-head evaluations are lacking. Patient compliance and satisfaction with chosen therapy hinge upon multifactorial considerations including cost, efficacy, time, and adverse effects. Knowledge gaps, negative experiences, and inadequate communication with healthcare providers present additional barriers to therapy adherence.
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Understanding patients’ preferences and aversions toward each therapy is pivotal for personalized counseling and optimal adherence. A previous study conducted by our team explored patient inclinations and impediments towards third-line OAB therapies. Notably, BTX-A was least favored due to potential self-catheterization requirements, SNM faced resistance due to the need for an implanted device, and PTNS was met with reluctance due to the necessity of frequent office visits for maintenance therapy. Moreover, PTNS compliance over the long term has been reported as low as 39.5% at 12 months, underscoring the need for alternative treatment modalities.
Of the third-line OAB therapies, ITNS shares similarities with PTNS in its proposed mechanism of action, albeit necessitating fewer office visits for treatment efficacy. However, owing to its novelty, limited information exists regarding patient reception and attitudes toward ITNS. As the repertoire of neuromodulation devices expands, clinicians must adeptly furnish individualized counseling to steer therapy selection. This study endeavors to scrutinize shifts in patient preference for third-line OAB therapies subsequent to the introduction of ITNS as a treatment option, alongside the established third-line therapies endorsed by guidelines.
Methods
Inclusion Criteria
– Participants must be adults of all genders residing in the United States, aged 18 years and above.
– Individuals with any range of income are eligible for participation.
– Participants must express symptoms indicative of overactive bladder (OAB).
Exclusion Criteria
– Individuals solely presenting symptoms of stress urinary incontinence (SUI) without concomitant symptoms of OAB will be excluded from participation.
– There are no additional exclusion criteria specified beyond the primary focus on individuals with symptoms of OAB.
This voluntary survey, administered via the SurveyMonkey platform, targets a diverse demographic of adults within the United States, aiming to capture responses from individuals experiencing symptoms of OAB. The research team, setting precise demographic parameters, ensures inclusivity across gender and socioeconomic strata. A research consent form is provided to participants before survey commencement, adhering to ethical standards. Screening questions discern individuals with symptoms pertinent to OAB, while excluding those solely manifesting symptoms of SUI. No form of compensation or reward is offered to participants, maintaining the integrity of responses. The survey entails ranking current third-line therapies for OAB—BTX-A, PTNS, and SNM—followed by the introduction of ITNS, allowing participants to rank their preferences among these options. Descriptions of therapies, including ITNS, are meticulously crafted based on the FDA-approved ITNS device available at the time of survey creation, ensuring accuracy and consistency in survey content.
Analysis
The descriptive analysis entailed examining both absolute and relative alterations in therapy preferences from stage A to stage B. This assessment aimed to discern shifts in participant inclinations following the introduction of the implantable tibial nerve stimulator (ITNS) alongside established therapies for overactive bladder (OAB). Inferential analysis sought to elucidate associations between the ultimate therapy choice at stage B and various participant characteristics, encompassing age, sex, race/ethnicity, household income, OAB symptoms, and prior OAB treatments. Statistical methods including one-way analysis of variance (ANOVA), χ2 test, or Fisher’s exact test were employed to explore these relationships. Data analysis was conducted utilizing SPSS software version 29.0 (IBM Corp), ensuring robust and comprehensive examination of the survey findings.
Results
The study enrolled a total of 485 participants, the majority of whom were female (62.5%), with an average age of 49.1 years. The racial distribution of the sample encompassed 69.1% Caucasian, 7.6% African American, 7.6% Asian, 12.7% Hispanic, and 2.9% other ethnicities. Participants hailed from diverse income backgrounds, with 46.8% reporting annual household incomes below $50,000. The prevalence of symptoms associated with overactive bladder (OAB) was notably high among respondents, with 73.0% reporting urge urinary incontinence (UUI), 68.0% experiencing urinary urgency, 44.1% reporting urinary frequency, and 55.1% reporting nocturia. Furthermore, a substantial proportion of participants had undergone prior OAB treatments, with 29.2% receiving medication, 8.7% undergoing BTX-A injections, 10.3% undergoing PTNS, and 8.0% undergoing SNM.
During the initial stage of the survey (stage A), participants were asked to rank their preferences for third-line OAB therapies, with 28% selecting BTX-A as their first choice, 27% preferring PTNS, and 13.8% opting for SNM. Notably, a significant portion (26.6%) indicated no preference for any therapy. In contrast, during the subsequent stage (stage B), following the introduction of the implantable tibial nerve stimulator (ITNS), preferences shifted. While 27.6% continued to favor BTX-A, the proportion favoring PTNS decreased to 19.2%, SNM to 7.8%, and 19.2% selected ITNS as their first choice. Additionally, 21.9% of participants opted for no therapy, and 4.3% expressed equal preference for all therapies.
A detailed analysis revealed both absolute and relative declines in preferences for BTX-A, SNM, and PTNS between stage A and stage B. Notably, participants initially interested in PTNS exhibited the most substantial decrease in preference following the introduction of ITNS. Preferences for ITNS versus other therapies or no therapy were found to be unrelated to demographic factors such as age, sex, race/ethnicity, or household income. However, individuals experiencing concurrent symptoms of stress urinary incontinence (SUI) showed a preference for other third-line therapies over ITNS. Moreover, participants with prior experience with third-line therapies, particularly BTX-A or PTNS, were more inclined towards alternative options rather than ITNS. Specifically, individuals with prior BTX-A or PTNS treatments displayed a greater preference for alternative third-line therapies.
Conclusion
Several significant advancements in neuromodulation procedures and devices have emerged for treating overactive bladder (OAB) over the past decade. Although implantable tibial nerve stimulator (ITNS) devices possess limited long-term data, initial studies suggest comparable response rates to sacral neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS), with added benefits of reduced cost and fewer adverse effects. This study represents the first of its kind, aiming to explore shifts in patient preferences for third-line OAB therapies upon the introduction of ITNS, the latest form of neuromodulation designed for OAB treatment.
Building upon a prior single-center study conducted by the institution, which examined patient preferences for BTX-A, PTNS, and SNM after providing educational counseling videos, the current study sought to evaluate a larger, more diverse sample of OAB patients. Unlike the previous study, where educational counseling was delivered via video interface, the current study integrated educational material within the survey itself, serving as reading material.
In the initial stage of the study, participants’ preferences for third-line therapies, as outlined in the AUA/SUFU guidelines, were assessed through text and pictorial descriptions. Results revealed a similar pattern of preferences compared to previous data, with BTX-A and PTNS garnering comparable rates of interest, while fewer participants opted for SNM. Notably, a larger proportion of participants expressed disinterest in any therapy in this study compared to the prior cohort, likely attributed to differences in participant populations.
Upon introducing ITNS in the second stage of the study, shifts in patient preferences were analyzed. Results indicated that a substantial number of participants originally interested in PTNS switched their preference to ITNS, given their shared mechanism of action. Moreover, a significant relative change in interest was observed among participants initially interested in SNM, with over 40% favoring ITNS as their primary choice. This shift may be attributed to the less invasive nature of ITNS compared to SNM, despite both involving implanted devices.
Furthermore, the study found that introducing ITNS prompted approximately 17% of patients who initially opted for no therapy to consider ITNS as a viable option. This suggests that ITNS may serve as an acceptable alternative for patients hesitant to pursue traditional third-line therapies.
Analysis of factors influencing therapy choice revealed a relationship between symptom severity and treatment preference, with patients experiencing stress urinary incontinence (SUI) symptoms showing a greater preference for other third-line therapies over ITNS. Additionally, individuals who had prior experience with third-line therapies were more inclined towards alternative options, potentially indicating satisfaction with existing treatments or hesitancy towards newer therapies with limited long-term data.
Despite the high prevalence of OAB, there remains poor progression from second- to third-line therapies, emphasizing the need to understand patient phenotypes suitable for ITNS to increase successful treatment outcomes. Factors such as age, body mass index, comorbidities, and concomitant bowel or sexual disorders play crucial roles in determining the efficacy of neuromodulation therapies.
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