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Figure 2. Modified QUOROM Flow Chart10,290 records identified from bibliographic searches5190 - Duplicate records removed5100 – Titles & abstracts screening3433 - Failed to meet inclusion criteria1667 Eligible for full text relevance assessment1354 - Failed to meet inclusion criteria:(1257) Not an original study, or population ofinterest, intervention of interest, oroutcome of interest(19) Observational injection study with < 6months followup in duration(28) Observational injection study ≥ 6months in duration not reporting theoutcome of interest(50) Not relevant by study design313 records met inclusion criteria from originalh194 records identified fromseparate NIAON search187 excluded323 records met inclusion criteria from all searchesQuestion 1• Prevalence (23)Question 2-3• Sildenafil (84)• Vardenafil (31)• Tadalafil (37)• Apomorphine (11)• Intracavernosal injections (43)• Subcutaneous Injections (4)• Intra-urethral suppositories (7)• Hormonal Treatments (20)• Topicals (11)• Other (22)Question 3. Specific Harms• NAION (10)• Fibrosis (20)22
Assessment of Study and Reporting QualityThe quality of prevalence studies measuring serum hormonal levels in ED patients wasassessed using a subset of QUADAS items. 46 The QUADAS tool consists of 14 items (AppendixB). QUADAS was designed to evaluate the diagnostic accuracy of a test against the referencestandard. Since the included studies for this review involved measurements of serum hormonelevels, no reference standards were used to assess the diagnostic accuracy of these tests (i.e.,levels of testosterone, prolactin, LH and/or FSH). Therefore, the quality assessment of studieswas based on a subset of 8 QUADAS items (score range 1–5) that were deemed to be relevant tothe present research question.The Jadad scale was used to assess the methodological and reporting quality of RCTs.(Appendix B). 47 This instrument is designed to assess the reporting of methods used to generaterandom assignments and double blinding, as well as to determine whether there is a descriptionof dropouts and withdrawals by treatment group (i.e., number and reasons). The scoring rangesfrom 0 to 5, with higher scores indicating higher quality. An a priori threshold scheme was usedfor sensitivity analysis: a Jadad total score of >3 indicated studies of higher quality. In addition,the adequacy of allocation concealment was assessed using an approach proposed by Schulz andcolleagues as: adequate, inadequate, or unclear (Appendix B). 48Synthesis of EvidenceQualitative data synthesis. Primary and secondary outcomes were summarized qualitativelyfor each study. The sample size and demographics, setting, funding source, treatment andcomparator characteristics (e.g. type, dose, and duration), study quality, and methods ofadjustment for confounders (where applicable) were recorded and summarized in the text, andsummary tables.To determine the clinical utility of routine hormonal blood tests in identifying and affectingtherapeutic outcomes for endocrine causes of ED (KQ 1), the reviewers identified relevantstudies and synthesized data for two following constructs:1. The prevalence of hormonal abnormalities (hypogonadism, hyperprolactinemia, abnormallevels of luteinizing and/or follicle-stimulating hormones) in patients with ED2. The efficacy of hormonal therapies in patients with the above-mentioned hormonalabnormalities for improving clinical symptoms of ED.The two constructs (i.e., prevalence of hormonal abnormalities and efficacy of availablehormonal treatments) jointly determine the clinical utility of routine hormonal blood tests. Forexample, the administration of routine hormonal blood tests might be justified only if theprevalence of hormonal abnormalities in patients with ED was relatively high (i.e., above a prespecifiedthreshold) and the available hormonal therapies in affecting symptoms of ED in thissubgroup of patients were effective.Thus, the results for KQ 1 are presented in two sub-sections: 1) the prevalence of hormonalabnormalities in ED patients and 2) the efficacy of hormonal therapy in treating ED in patientswith hormonal abnormalities (see also the section for KQ 2-3, Hormonal Treatments, for moredetailed description of the studies).Quantitative synthesis. The decision whether to perform statistical pooling of individualstudies was based on clinical and methodological judgment. In the case of outcomes for whichmeta-analysis was deemed appropriate, we extracted quantitative data (e.g. number of subjects ineach group, mean, standard deviation) from reports using a standardized data extraction form23
Page 1 and 2: This report is based on research co
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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
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Page 25 and 26: disease). Furthermore, there is ins
Page 27: Analytic FrameworkFigure 1. Analyti
Page 30 and 31: KQ 3. Harms of pharmaceutical treat
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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
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Page 72 and 73: scheduled dosing regimen (90 percen
Page 74 and 75: Proportion of patients with improve
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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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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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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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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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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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AuthorYearSaylan 2006 265 Jadad Q-1
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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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