OBJECTIVES: The objective of this research was to review the published literature to identify what patient-reported outcome (PRO) measures have been used in evaluation of BPH medications. METHODS: The literature review was carried out in two phases: Phase I focused on BPH-specific treatments and BPH-specific PRO measures while phase II expanded its scope to include other urinary conditions, non-disease-specific quality of life PRO measures and utility studies. Phase I included terms for BPH and terms for PRO measures. The 279 abstracts were narrowed by focusing on medical interventions and more widely read journals. The remaining 125 abstracts were reviewed. In Phase II, we expanded the search to include general quality of life (QOL) domains in the context of other urinary conditions and utility studies. The 273 abstracts identified were reviewed by 2 researchers to isolate the articles of interest, leaving 70 articles. RESULTS: We identified 64 articles from Phase I and 70 articles from Phase II. Among the Phase I articles, 52 reported using the International Prostate Symptoms Score (IPSS). 44 articles which used the IPSS were able to detect a significant change in the symptom scores. The remaining articles used various other PRO measures for their BPH endpoints. Of the 70 articles yielded from the Phase II search, 11 were utility studies, 25 were BPH-specific articles, 29 were overactive bladder (OAB)-specific articles, and 5 were urge urinary incontinence (UUI)-specific articles. From the BPH, OAB, and UUI articles, we identified the key QOL instruments utilized to measure the various domains key to BPH. CONCLUSIONS: There have been a large number of PRO measures used in the literature to study BPH and related endpoints. It is clear that the IPSS has been used in the majority of the studies focused on BPH symptoms (81.25% of the ones reviewed).