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Patient-Reported Outcomes in Endpoints for Devices Treating Benign Prostate Hyperplasia Symptoms

Clinical Context

Benign prostatic hyperplasia (BPH) is the non-cancerous enlargement of the prostate gland in men. The enlarged prostate can cause urinary symptoms including a frequent or urgent need to urinate, difficulty starting urination, and the inability to completely empty the bladder. Depending on the severity of symptoms and the age of the patient, medications, minimally invasive therapies, and surgery can be used to treat BPH symptoms.

Device Description

The UroLift System (De Novo DEN130023) is a Class II implantable transprostatic tissue retractor system used when performing a minimally invasive prostatic urethral lift (PUL) to treat BPH symptoms.

Indications for Use

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men age 50 and above.

Context of Clinical Outcome Assessment (COA) Use

To establish effectiveness of the device, the change from baseline in the International Prostate Symptom Score (IPSS) was compared for superiority of the UroLift system over a sham intervention after 12 months. The IPSS is a patient-reported outcome (PRO) instrument that assesses a patient’s urinary symptoms and their impact on the patient’s quality of life.

Three of four secondary effectiveness endpoints in the pivotal trial were also PRO instruments assessing:

  • Erectile function (International Index of Erectile Function)
  • Quality of life
  • Impact of BPH symptoms on a patient’s life (Benign Prostatic Hyperplasia Impact Index).

Lessons Learned

Measuring factors that matter most to the patient (for example, symptom impact on daily life, erectile function, and overall quality of life) with PRO instruments is an important component when evaluating BPH treatments. In fact, regulatory guidance recommends including clinically meaningful primary effectiveness endpoints that fully characterize the effect of treatment. This granting of this De Novo request demonstrates using PRO instruments as both primary and secondary endpoints to evaluate device effectiveness.

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