FDA Publish Guidance on the Non-Clinical and Clinical Investigations of Devices for the Treatment of Benign Prostatic Hyperplasia (BHP).

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As men age, the prostate enlarges over time obstructing the prostatic urethra and interfering with sphincter function. The resulting condition, known as benign prostatic hyperplasia (BPH), is associated with decreased peak urinary flow rate (Qmax) and increased post void residual urine (PVR). Men with BPH experience bothersome lower urinary tract symptoms (LUTS) that affect their quality of life by disrupting sleep patterns or interfering with daily activities.
Although BPH is uncommon in young men, it is remarkably common in older men. Epidemiological studies estimate that 50% of men have histological BPH by age 60. The prevalence increases to 90% in men over 85. Similar to the histological evidence, the prevalence of LUTS and other clinical indicators of BPH increases with age and is similar across various countries and ethnic groups studied. Therefore, BPH is considered asignificant medical condition that has, and will continue to have, considerable public health impact.
A well‐designed, scientifically sound investigational plan, both non‐clinical and clinical, is essential to evaluate the safety and effectiveness of a medical device intended to treat BPH.
Prior to use in humans, it is essential to demonstrate that the device will function as intended in its environment of use. The design of medical devices involves the development and verification of a battery of specifications that define basic safety and performance requirements of the device. Most design specifications are validated in non‐clinical testing, which allows assessment of device function and safety under controlled circumstances. Additionally, a comprehensive non‐clinical battery of testing provides a foundation for evaluating future changes to the device.
The ultimate goal when conducting a clinical investigation of a device to treat BPH is to design a study using objective, unbiased outcomes to measure the safety and effectiveness of treatment. Major challenges faced when designing a clinical study to assess the safety and effectiveness of a BPH device include the placebo effect and spontaneous remissions that commonly occur with BPH, the inherent variability and subjectivity of the typical outcome measures commonly used to assess the effectiveness of treatment, and the availability of effective treatments for BPH.
This guidance identifies the key features of non‐clinical and clinical investigational plans used to support investigational device exemptions (IDEs), premarket approval applications (PMAs), and some premarket notifications (510(k)s) for devices used in the treatment of BPH. Some recommendations in this document may not apply to a particular device, and additional recommendations may be appropriate for novel device types or technologies. FDA will consider alternative non‐clinical and clinical testing when the proposed alternatives are supported by an adequate scientific rationale. We encourage you to contact the Urology and Lithotripsy Devices Branch (ULDB) when designing your clinical investigation and prior to submission of an original IDE application.

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