Efficacy and safety of PDE5 inhibitors in the treatment of diabetes mellitus erectile dysfunction: Protocol for a systematic review

INTRODUCTION: Diabetes mellitus erectile dysfunction (DMED) is a common complication of long-term hyperglycemia. With the increasing of diabetic patients, the number of DMED patients is gradually growing up, which has a serious impact on the quality of life of patients. PDE5 inhibitors have good clinical efficacy in DMED patients. This study is designed to evaluate the efficacy and safety of PDE5 inhibitors in DMED patients. METHODS AND ANALYSIS: We will systematically search all randomized controlled trials (RCTs) by electronic and manual search. Electronic retrieval of the database includes Pubmed, EMBASE, The Cochrane Library, the Chinese BioMedical Literature Database, the China National Knowledge Infrastructure (CNKI), the China Science and Technology Journal database (VIP) and the Wanfang database. Manual search will retrieve gray literature, including dissertations, ongoing experiments, grey literature, conference and unpublished documents. We use the IIEF-5 scale as the primary outcome of DMED. We also need to pay attention to the following outcomes: the sexual satisfaction of patients and their partners, like IIEF Q3 Q4; SEP 2, 3; GAQ. More importantly, the adverse reactions of patients during medication will also be taken seriously. Two reviewers will independently read the articles, extract the data information, and give the assessment of risk of bias. Data analysis will be used the special software like RevMan (version 5.3.5), ENDNOTE X7 and STATA 13. RESULTS: This study will provide a comprehensive assessment based on current evidence of PDE5 inhibitors for DMED, especially its impacts on International Index of Erectile Function, the sexual satisfaction of patients and their partners and safety. ETHICS AND DISSEMINATION: This systematic review will evaluate the efficacy and safety of PDE5 inhibitors on DMED. This review does not require ethical approval and will be reported in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO CRD42018095185.