Developing a novel, non-hormonal treatment paradigm for vaginal dryness in breast cancer survivors

这项快速跟踪SBIR的目标是证明基于治疗性超声的 治疗乳腺癌幸存者和绝经后阴道干燥症状的医疗设备 女人。今天治疗阴道干燥的最好方法都涉及到激素的使用；然而，激素治疗 对于患有阴道干燥的140万乳腺癌幸存者来说是禁忌(由于存在 癌症复发)。此外，数以百万计的绝经后妇女避免使用激素，因为 风险和令人不快的副作用。Madorra已经开发出一种医疗设备，它使用治疗性超声波来 恢复阴道润滑，完全缓解阴道干燥的症状，不需要激素 心理治疗。Madorra团队进行的初步研究表明，阴道应用的前景 治疗性超声波治疗女性阴道病患者在家中每天使用的阴道干燥 干涩。然而，在这些研究中使用的经过修改的现成超声设备很麻烦，而且 给研究参与者带来了巨大的可用性挑战。研究中的女性抱怨这名用户 界面，编程正确的超声波剂量的挑战，定位和握持设备的困难 在治疗过程中，以及每次使用后清洁设备的负担。因此，一种超声设备，其 可以有效地将所需的超声波直接传递到阴道组织，同时使用方便(因此也很容易 最终用户采用)是必需的。Madorra根据用户的反馈开发了这样的设备，但它 尚未进行临床试验。这项快速通道SBIR提案将支持首次临床使用 马多拉装置。第一阶段包括对Madorra装置的小型单臂试点研究，第二阶段 包括一项更大规模的随机、假对照的关键研究。将使用试点研究(具体目标1-3) 收集Madorra设备的初步临床使用经验数据，包括：安全性、生理学证明 响应、易用性验证和初步疗效。关键研究(具体目标4-6)将收集 具有统计学意义的安全性和有效性数据显示Madorra装置治疗阴道的能力 与假的设备相比，干涩。这些数据将提交给FDA以支持设备 批准并将用于不可逆转地确立Madorra设备的临床疗效。曾经的FDA 获批后，Madorra设备将商业化，并将允许数百万乳腺癌幸存者和 绝经后妇女恢复其性健康和提高其生活质量。

The goal of this Fast-Track SBIR is to demonstrate the safety and efficacy of a therapeutic-ultrasound-based medical device to treat the symptoms of vaginal dryness for breast cancer survivors and postmenopausal women. Today's best treatments for vaginal dryness all involve the use of hormones; yet, hormonal treatments are contraindicated for the 1.4 million breast cancer survivors suffering from vaginal dryness (due to the risk of cancer recurrence). Further, millions of postmenopausal women avoid hormone use because of the long-term risks and unpleasant side effects. Madorra has developed a medical device that uses therapeutic ultrasound to revitalize vaginal lubrication, abating symptoms of vaginal dryness completely without the need for hormone therapy. Preliminary research conducted by the Madorra team has indicated the promise of vaginally applied therapeutic ultrasound to treat vaginal dryness when used daily in the home by women suffering from vaginal dryness. However, the modified off-the-shelf ultrasound devices used in those studies were cumbersome and posed significant usability challenges for the study participants. Women in the study complained about the user interface, challenges in programming the correct ultrasound dose, difficulty positioning and holding the device during therapy, and the burdens of cleaning the device after each use. Accordingly, an ultrasound device that can effectively deliver desired ultrasound directly to vaginal tissue while being easily used (and hence readily adopted by end users) is required. Madorra has developed such a device based on this user feedback, but it has not yet been tested clinically. This Fast-Track SBIR proposal would support the first clinical use of the Madorra device. Phase I encompasses a small, single-arm, Pilot Study of the Madorra device, and Phase II comprises a larger randomized, sham-controlled Pivotal Study. The Pilot Study (Specific Aims 1-3) will be used to gather initial clinical use experience data on the Madorra device, including: safety, proof of physiologic response, validation for ease of use, and preliminary efficacy. The Pivotal Study (Specific Aims 4-6) will collect statistically significant safety and efficacy data demonstrating the Madorra device's ability to treat vaginal dryness in comparison to a sham device. These data will be submitted to the FDA in support of device approval and will serve to irrevocably establish the clinical efficacy of the Madorra device. Once FDA approved, the Madorra device will be commercialized and will allow millions of breast cancer survivors and postmenopausal women to regain their sexual wellness and improve their quality of life.