Department of Urology, Stony Brook Medicine, Stony Brook, New York, USA.
Neurourol Urodyn. 2024 Apr;43(4):959-966. doi: 10.1002/nau.25421. Epub 2024 Feb 23.
Third-line therapies for overactive bladder (OAB) that are currently recommended include intravesical Onabotulinumtoxin-A injections (BTX-A), percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM). The implantable tibial nerve stimulator (ITNS) is a novel therapy that is now available to patients with OAB.
The objective of this study was to analyze shifts in patient preference of third-line therapies for OAB after introducing ITNS as an option among the previously established therapies for non-neurogenic OAB.
A survey was designed and distributed via SurveyMonkey to the platform's audience of U.S. adults of age 18 and older. Screening questions were asked to include only subjects who reported symptoms of OAB. Descriptions of current AUA/SUFU guideline-approved third-line therapies (BTX-A, PTNS, and SNM) were provided, and participants were asked to rank these therapies in order of preference (stage A). Subsequently, ITNS was introduced with a description, and participants were then asked to rank their preferences amongst current guideline-approved therapies and ITNS (stage B). Absolute and relative changes in therapy preferences between stage A and stage B were calculated. Associations between ultimate therapy choice in stage B and participant characteristics were analyzed.
A total of 485 participants completed the survey (62.5% female). The mean age was 49.1 ± 36.5 years (SD). The most common OAB symptoms reported were urgency urinary incontinence (UUI) (73.0%) and urinary urgency (68.0%). 29.2% of patients had tried medication for OAB in the past, and 8.0%-10.3% of patients were previously treated with a third-line therapy for OAB. In stage A, participants ranked their first choice of third-line therapy as follows: 28% BTX-A, 27% PTNS, and 13.8% SNM. 26.6% of participants chose no therapy, and 4.5% chose all three equally. In stage B, participants ranked their first choice as follows: 27.6% BTX-A, 19.2% PTNS, 7.8% SNM, and 19.2% ITNS. 21.9% of participants chose no therapy and 4.3% chose all four equally as their first choice. There were both absolute and relative declines in proportions of patients interested in BTX-A, SNM, and PTNS as their first choice of third-line therapy with the introduction of ITNS. Patients originally interested in PTNS in stage A had the greatest absolute change after the introduction of ITNS with 7.8% of participants opting for ITNS in stage B. Those interested in SNM in stage A had the largest relative change in interest, with 43.5% of those originally interested in SNM opting for ITNS in stage B. Finally, with the introduction of ITNS, the number of participants initially not interested in any third-line therapy declined by an absolute change of 4.7% and relative change of 17.6%. Participants experiencing concurrent stress urinary incontinence (SUI) symptoms were more likely to choose a current guideline-approved third-line therapy than ITNS or no therapy at all (p = 0.047). Those who had prior experience with third-line therapies were more likely to choose a third-line therapy other than ITNS as their ultimate choice of therapy in stage B. Of those who had chosen a guideline-approved third-line therapy in stage B (not ITNS), 13.6% had prior experience with BTX-A, 14.7% with PTNS, and 32 (11.2%) with SNM (p < 0.001, p < 0.001, p = 0.009, respectively).
From our study, it appears that ITNS may attract a subset of patients who would not have otherwise pursued current guideline-approved third-line therapies for OAB. When patients are provided with descriptions of third-line OAB therapies including ITNS as an option, ITNS appears to compete with SNM and PTNS. It is possible that ITNS will provide patients with a different phenotype of neuromodulation therapy that can appeal to a niche OAB population. Given that ITNS devices have been introduced relatively recently to the market, their application will largely depend on cost and payer coverage, provider bias, and patient comorbidities. Further study is needed to understand how these factors interact with and influence patient preference of advanced OAB therapy to understand which patients will most benefit from this treatment modality.
目前推荐的治疗膀胱过度活动症(OAB)的三线疗法包括膀胱内注射肉毒杆菌毒素 A(BTX-A)、经皮胫神经刺激(PTNS)和骶神经调节(SNM)。植入式胫神经刺激器(ITNS)是一种新的治疗方法,目前已可用于 OAB 患者。
本研究旨在分析在引入 ITNS 作为非神经源性 OAB 先前既定疗法的一种选择后,患者对 OAB 三线疗法的偏好转移。
设计了一项调查,并通过 SurveyMonkey 分发给美国 18 岁及以上成年人的平台受众。询问了筛选问题,仅包括报告有 OAB 症状的受试者。提供了当前 AUA/SUFU 指南批准的三线疗法(BTX-A、PTNS 和 SNM)的描述,并要求参与者按照偏好程度对这些疗法进行排序(阶段 A)。随后,引入了 ITNS 的描述,并要求参与者在当前指南批准的疗法和 ITNS 之间进行偏好排序(阶段 B)。计算了阶段 A 和阶段 B 之间治疗偏好的绝对和相对变化。分析了阶段 B 中最终治疗选择与参与者特征之间的关联。
共有 485 名参与者完成了调查(62.5%为女性)。平均年龄为 49.1±36.5 岁(标准差)。报告的最常见 OAB 症状是急迫性尿失禁(UUI)(73.0%)和尿急(68.0%)。29.2%的患者过去曾接受过 OAB 药物治疗,8.0%-10.3%的患者曾接受过三线疗法治疗 OAB。在阶段 A 中,参与者将他们的三线治疗首选排序如下:28% BTX-A、27% PTNS 和 13.8% SNM。26.6%的参与者选择不治疗,4.5%的参与者选择三者同等。在阶段 B 中,参与者的首选排序如下:27.6% BTX-A、19.2% PTNS、7.8% SNM 和 19.2% ITNS。21.9%的参与者选择不治疗,4.3%的参与者选择四者同等作为他们的首选。随着 ITNS 的引入,对 BTX-A、SNM 和 PTNS 作为三线治疗首选的患者比例均出现绝对和相对下降。在阶段 A 中对 PTNS 感兴趣的患者,在引入 ITNS 后绝对变化最大,有 7.8%的参与者在阶段 B 中选择 ITNS。在阶段 A 中对 SNM 感兴趣的患者,兴趣变化最大,在阶段 B 中有 43.5%的最初对 SNM 感兴趣的患者选择 ITNS。最后,随着 ITNS 的引入,最初对任何三线治疗均不感兴趣的参与者数量绝对减少了 4.7%,相对减少了 17.6%。同时患有压力性尿失禁(SUI)症状的参与者更有可能选择当前指南批准的三线治疗方法,而不是 ITNS 或完全不治疗(p=0.047)。有三线治疗经验的参与者更有可能选择除 ITNS 以外的三线治疗方法作为他们在阶段 B 中的最终治疗选择。在阶段 B 中选择了指南批准的三线治疗方法(非 ITNS)的患者中,有 13.6%的患者之前曾接受过 BTX-A 治疗,14.7%的患者之前曾接受过 PTNS 治疗,32 名(11.2%)患者之前曾接受过 SNM 治疗(p<0.001,p<0.001,p=0.009,分别)。
从我们的研究中可以看出,ITNS 可能会吸引一部分原本不会选择当前指南批准的 OAB 三线治疗方法的患者。当向患者提供包括 ITNS 作为选择的三线 OAB 治疗方法的描述时,ITNS 似乎与 SNM 和 PTNS 竞争。有可能 ITNS 将为患者提供一种不同的神经调节治疗方式,吸引特定的 OAB 人群。鉴于 ITNS 设备最近才被引入市场,它们的应用将在很大程度上取决于成本和支付方覆盖范围、提供者的偏见和患者的合并症。需要进一步研究来了解这些因素如何相互作用并影响患者对高级 OAB 治疗的偏好,以了解哪些患者将从这种治疗方式中获益最大。