Do Minimally Invasive Benign Prostatic Hyperplasia Treatments Preserve Sexual Function? A Contemporary Review of the Literature.

PURPOSE OF REVIEW: The aim of this study is to compare the sexual function outcomes related to minimally invasive surgical therapies (MISTs) (UroLift®, Rezum™, Aquablation®, prostate artery embolization, and iTind®) for the treatment of benign prostatic hyperplasia (BPH). RECENT FINDINGS: Clinical trials and retrospective data evaluating MISTs for BPH have demonstrated improved or stable sexual function outcomes when compared to sham control or transurethral resection of the prostate. Outcomes were assessed at baseline and following treatments using patient-reported outcome measures. Rezum and Aquablation demonstrated preservation of overall ejaculatory function and erectile function at 36-month follow-up. Similar outcomes occurred with UroLift after a 60-month follow-up. Erectile function was preserved following prostate artery embolization and iTIND up to 12 months. MIST for the management of BPH has been demonstrated to be effective in improving urinary function and appears to minimize potential collateral damage on sexual function following treatment.

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals.

BACKGROUND: "Patient experience data" (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment traditional clinical trial data in the FDA's review of product applications. Section 3001 of the 2016 21st Century Cures Act requires the FDA to make a public statement about the PED considered in the approval of a drug application. Here, we present one of the first assessments of PED consideration during drug application approval, as reported by the FDA under Sec. 3001 of the Cures Act. METHODS: FDA reported use of PED in the Review Documentation of the 59 new molecular entities (NMEs) approved in 2018 were collected, indexed, and cross-referenced against information regarding FDA review and product regulatory designation. The data reported in the PED tables were quantitatively described and visualized. RESULTS: Of the 59 approved NMEs in 2018, 48 include a table that summarized whether PED was or was not used during the FDA drug review. Thirty-four of those 48 approvals (70.8%) reported using PED in the drug review. Patient-reported outcomes(PROs) represented the most significant source of PED and were used in 60.4% of approved drug reviews. Additional findings, including PED use by FDA review division and by FDA regulatory designation, are described. CONCLUSIONS: This assessment is a first step to better understanding how FDA considers PED in regulatory decision making. This analysis should help develop a baseline regarding FDA use of PED and may inform decisions to ensure patients' experiences are adequately heard in future drug development.

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals.

BACKGROUND: "Patient experience data" (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment traditional clinical trial data in the FDA's review of product applications. Section 3001 of the 2016 21st Century Cures Act requires the FDA to make a public statement about the PED considered in the approval of a drug application. Here, we present one of the first assessments of PED consideration during drug application approval, as reported by the FDA under Sec. 3001 of the Cures Act. METHODS: FDA reported use of PED in the Review Documentation of the 59 new molecular entities (NMEs) approved in 2018 were collected, indexed, and cross-referenced against information regarding FDA review and product regulatory designation. The data reported in the PED tables were quantitatively described and visualized. RESULTS: Of the 59 approved NMEs in 2018, 48 include a table that summarized whether PED was or was not used during the FDA drug review. Thirty-four of those 48 approvals (70.8%) reported using PED in the drug review. Patient-reported outcomes (PROs) represented the most significant source of PED and were used in 60.4% of approved drug reviews. Additional findings, including PED use by FDA review division and by FDA regulatory designation, are described. CONCLUSIONS: This assessment is a first step to better understanding how FDA considers PED in regulatory decision making. This analysis should help develop a baseline regarding FDA use of PED and may inform decisions to ensure patients' experiences are adequately heard in future drug development.