Interventions (experimental/control): Oral (PDE–5 inhibitors, sublingual) injections (IC, SC), hormonal (e.g. testosterone), intra-urethral suppositories, CPAP, and/or topical (e.g. patch, cream)

Outcomes: Any adverse events, serious adverse events, withdrawals due to adverse events, and specific adverse events.

KQ 3a. The incidence of specific harms such as Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) and penile fibrosis associated with use of PDE–5 inhibitor and injection therapies, respectively. The review included reports of non-RCTs or observational studies. For identification of data on fibrosis related to use of injection therapies, only studies with at least 6 months of followup were included.

Study selection criteria included the following:

Source: Primary study report published in English

Study design: Non-RCTs (experimental or observational case-control and cohort studies, case reports and case-series)

Population: Adults (age ≥ 18 years) diagnosed with ED (with or without comorbidities) Interventions (experimental/control): Oral (PDE–5 inhibitors), injections (IC, SC)

Outcomes: NAION, penile fibrosis Systematic and narrative reviews, case reports, editorials, commentaries or letters to the editor were excluded for all questions except Q3–a (specific harms). Studies evaluating interventions such as penile implant devices or natural health products used for the treatment of ED were also excluded.

The results of the literature search were uploaded to the software program TrialStat SRS version 4.0 along with screening questions developed by the review team and any supplemental instructions. A calibration exercise was undertaken to pilot and refine the screening process. One reviewer screened bibliographic records (i.e., title, authors, key words, abstract) using broad screening criteria (Appendix B). All potentially relevant records and those records that did not contain enough information to determine eligibility (e.g. no abstract was available) were retained. The reasons for exclusion are noted in the QUOROM flow diagram. Two reviewers independently performed full-text relevance screening. Disagreements were resolved by consensus.

Relevant studies were then evaluated to determine study design and were categorized accordingly for inclusion by question. The level of eligible evidence on efficacy was limited to RCTs, since systematic bias is minimized in RCTs compared with all other study designs (e.g. cross-sectional, retrospective cohort).

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