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KQ 3. Harms of pharmaceutical treatments (e.g. oral, injections, hormonal, topical, intraurethralsuppositories) in males with ED. Evidence on the following treatment modalities wasexcluded from this review: Natural health products (e.g. herbals), yohimbine, vacuumconstriction devices, and sex or surgical therapies (e.g. penile prosthesis implantation, penilearterial reconstructive surgery). Study selection criteria included the following:Source: Primary study report published in EnglishStudy design: RCTs (comparative efficacy and harms studies)Population: Adults (age ≥ 18 years) diagnosed with ED (with or without comorbidities)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 OpticNeuropathy (NAION) and penile fibrosis associated with use of PDE–5 inhibitor and injectiontherapies, respectively. The review included reports of non-RCTs or observational studies. Foridentification of data on fibrosis related to use of injection therapies, only studies with at least 6months of followup were included. Study selection criteria included the following:Source: Primary study report published in EnglishStudy 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 fibrosisSystematic and narrative reviews, case reports, editorials, commentaries or letters to theeditor were excluded for all questions except Q3–a (specific harms). Studies evaluatinginterventions such as penile implant devices or natural health products used for the treatment ofED were also excluded.The results of the literature search were uploaded to the software program TrialStat SRSversion 4.0 along with screening questions developed by the review team and any supplementalinstructions. A calibration exercise was undertaken to pilot and refine the screening process. Onereviewer screened bibliographic records (i.e., title, authors, key words, abstract) using broadscreening criteria (Appendix B). All potentially relevant records and those records that did notcontain enough information to determine eligibility (e.g. no abstract was available) wereretained. The reasons for exclusion are noted in the QUOROM flow diagram (Figure 2). Tworeviewers independently performed full-text relevance screening. Disagreements were resolvedby consensus. Reasons for exclusion were noted (Appendix E).Relevant studies were then evaluated to determine study design and were categorizedaccordingly for inclusion by question. The level of eligible evidence on efficacy was limited toRCTs, since systematic bias is minimized in RCTs compared with all other study designs (e.g.cross-sectional, retrospective cohort).Data AbstractionTwo reviewers independently abstracted relevant information from each included study usinga data abstraction form developed a priori for this review (Appendix B). One reviewer completedprimary extraction, which was then verified by a second reviewer. Conflicts were discussed and20
resolved by consensus. Abstracted data included study characteristics (e.g. design, sample size,country), population characteristics (e.g. age, comorbidities, severity of ED), name/type oftreatment (e.g. sildenafil, testosterone), route of administration (e.g. oral, injection, topical),dose, and the duration of treatment. The following clinically relevant and validated efficacyoutcomes were abstracted: absolute endpoint/change (from baseline) in scores for theInternational Index of Erectile Function “Erectile Function” domain (IIEF– EF), per-patientpercentage on Sexual Encounter Profile for Q2 and Q3 (SEP–Q2/Q3), and the proportion ofpatients with improved erection measured with a Global Assessment (or Efficacy) Question(GAQ–Q1 or GEQ–Q1).(Appendix H)For harms, reviewers abstracted information on any adverse events: i.e., number of patientswho developed at least one adverse event; most frequently encountered specific adverse events;withdrawals due to adverse events; and the incidence of serious adverse events. Additionally, forQ1, prevalence estimates of hypogonadism and hyperprolactinemia in ED populations for eachincluded study were abstracted.21
Page 1 and 2: This report is based on research co
Page 3 and 4: This document is in the public doma
Page 5 and 6: AcknowledgmentsThe authors would li
Page 7 and 8: ContentsExecutive Summary..........
Page 9 and 10: Table 17: Intra-urethral Treatment:
Page 11 and 12: Figure 63. Absolute Mean Change Fro
Page 13 and 14: associated with ED treatments. Two
Page 15 and 16: ED as a main complaint. In only one
Page 17 and 18: different formulations/modes of app
Page 19 and 20: Evidence Report
Page 21 and 22: flaccidity are no less important th
Page 23 and 24: prostatectomy, antipsychotic agents
Page 25 and 26: disease). Furthermore, there is ins
Page 27: Analytic FrameworkFigure 1. Analyti
Page 32 and 33: Figure 2. Modified QUOROM Flow Char
Page 34 and 35: that included intervention characte
Page 36 and 37: Prevalence of Hypogonadism (Total S
Page 38 and 39: stimulation and a challenge test wi
Page 40 and 41: Overview of Trials79-84,86-88,90,91
Page 42 and 43: 131,137,138,142,143,147,151,155,156
Page 44 and 45: pectoris occurred in a participant
Page 46 and 47: statistical test results for the ob
Page 48 and 49: individual Q1-Q15 items, 104,106,15
Page 50 and 51: Proportion of participants with hea
Page 52 and 53: erectile maintenance frequency, IIE
Page 54 and 55: Oral Treatments — Phosphodiestera
Page 56 and 57: Patients were instructed to take th
Page 58 and 59: Results obtained from two trials 19
Page 60 and 61: improved erections was higher in pa
Page 62 and 63: Clinically homogenous groups of pat
Page 64 and 65: Oral Treatments — Phosphodiestera
Page 66 and 67: The approximate proportion of smoke
Page 68 and 69: value was not reported). Even thoug
Page 70 and 71: Tadalafil (20 mg) versus tadalafil
Page 72 and 73: scheduled dosing regimen (90 percen
Page 74 and 75: Proportion of patients with improve
Page 76 and 77: Sublingual Treatments - Apomorphine
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apomorphine (5 and 6 mg: 38 and 49
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heterogeneity with respect to popul
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Finally, two studies reported on wh
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the second study, prolonged erectio
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Moxisylate versus placebo. One tria
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Quantitative SynthesisThere was a l
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erection” versus one placebo trea
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methods of allocation concealment.
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Prazosin (IU) versus placebo. One t
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reported adequate allocation concea
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Hormonal Treatments Literature Sear
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Harms. In the first trial, the diff
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sex with partner (scale 1-6, with =
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daily for 4 weeks followed by concu
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(MEDQoL) score (range 0-100) compar
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group (16.7, 12.5, and 8.3 percent,
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Question 3a. What Are the harms of
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Chapter 4. DiscussionThis evidence
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Question 1: What is the Clinical Ut
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Questions 2-3: What are the Benefit
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Harms. There were no obvious differ
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alone. Compared with trimix alone,
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PhentolamineEfficacy. The results i
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Question 2a-b: Do Specific Patient
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Methodological and Logistic Limitat
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Tables and Figures.Summary TablesTa
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123Study details 1 Study Design Set
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125Table 2: Prevalence of Hypogonad
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127Study Details 2 Study Design Set
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129Table 4: Prevalence of Hypogonad
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131Study Details 5 Study Design Set
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Table 7: Prevalence of Hyperprolact
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135StudyEDDetails 8 Study Design Se
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Table 10: Serious Adverse Events in
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Table 11: Efficacy Results of Tadal
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Treatment Control Relative RiskStud
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Treatment Control Relative RiskStud
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Table 14: Intracavernosal Injection
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StudyAdverse EventsTreatmentGroup%
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StudyAdverse EventsTreatment Contro
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Study / Typeof PatientsOutcome Defi
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Study ED Etiology OutcomeWilliams*1
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Physiologic:60.0 (18/30) 90.0 (27/3
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StudyAdverse EventTreatmentGroup% (
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TreatmentStudy ED Etiology Group% (
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StudyAdverse EventCavallini 1991 Pa
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Study/patient CharacteristicsGooma
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Aversa 2003Men witharteriogenicEDYa
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Study/patientCharacteristicsClopper
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Study/patientCharacteristicsOutcome
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Table 26: Testosterone Treatment: P
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McNicholas2002Patients reporting
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175Table 27: Miscellaneous Treatmen
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177Table 28: Nonarteritic Anterior
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Table 29: Penile Fibrosis in Studie
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StudyStudyDesignPatientsage range 4
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Figure 6. Improved erection (GEQ-Q1
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Figure 11. Visual disturbances (all
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Figure 16. Any adverse events (trea
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Figure 23. The mean IIEF-Q4 score:
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Figure 30. Improved erection (GEQ-Q
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Figure 37. Visual disturbances (all
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Figure 43. IIEF-EF ≥ 26 at follow
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Figure 49. Dyspepsia (all cause)Fig
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Figure 55. Serious adverse events (
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Figure 61. Mean per-patient percent
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Figure 67. Any adverse events (all-
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Figure 73. Any adverse events (all-
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in men with erectile dysfunction. J
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parameters in obese men with erecti
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comparative crossover study. Androl
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153. Shabsigh R. Efficacy of silden
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190.191.Stief C, Porst H, Saenz dT,
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treatment of men with erectile dysf
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randomized trial. J Urol 1997 Oct;1
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moderate and severe ED. Int J Impot
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349.350.351.randomized, placebo-con
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395. Moher D, Schulz KF, Altman DG.
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PSVRCTRIRIASBPSCSDSETTGTRTWMDpeak s
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dDegDept.Ff/uFHxhrHxIGMmaxminmoNANI
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30. or/24-2931. (ANIMALS not HUMAN)
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27. limit 26 to yr="1990 - 2008"28.
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5. exp clinical trials/6. random$.m
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20. or/17-1921. 16 and 2022. limit
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A systematic review of harms associ
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B-4Summary Table- Randomized Contro
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The Quality Assessment of Studies o
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AuthorFundingN; study design; eligi
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Douglass M A, Lin J C. Update on th
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Roehrborn C G, McNicholas T. The Ma
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Musacchio Najah S, Hartrich Molly,
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AuthorYearHellstrom 2005 37 Jadad Q
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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AuthorTotal AllocationJadad Q-1 Jad
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F-10STUDY IDQ1:SpectrumQ2.Selection
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Figure G-2. Sildenafil (any dose) v
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Figure G-8. Sildenafil (25 mg) vs.
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Figure G-10. Vardenafil (any dose)
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Tadalfil20 mg vs. PlaceboFigure G-1
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Figure G-14. Tadalafil (20 mg) vs.
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Figure G-16. Tadalafil (20mg) vs. T
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5 = Eleven+ attempts Q7: When you a
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The IIEF-5 score is the sum of ques
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El Malik EMA. Erectile dysfunction:
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