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Chapter 2. MethodsKey Questions Addressed in This ReportThe UO–EPC’s evidence report on the diagnosis and treatment of erectile dysfunction(ED) is based on a systematic review of the scientific literature. A technical expert panelwas recruited to help refine key questions and provide expertise to the review teamduring the review process.The finalized key questions were:KQ 1. To determine the clinical utility of routine blood tests - testosterone, prolactin,luteinizing hormone (LH), or follicle-stimulating hormone (FSH) - in identifying andtreating specific hormonal causes of ED.KQ 2. To determine the benefits of pharmaceutical treatments for patients with ED.KQ 3. To determine the harms of pharmaceutical treatments for patients with ED.The secondary objectives of this evidence report were:KQ 2–a. To explore how patient-specific characteristics (e.g. specificsymptoms/age/comorbid conditions) may affect prognosis and treatment success for EDpatients.KQ 2–b. To determine if the likelihood of treatment success varies by underlying causeof ED.KQ 3–a. To identify specific harms—nonarteritic ischemic optic neuropathy (NAION),penile fibrosis—of pharmaceutical treatments in patients with ED.Appendixes and Evidence Tables for this report are provided electronically athttp://www.ahrq.gov/downloads/pub/evidence/pdf/erectiledys/erecdys.pdf
Analytic FrameworkFigure 1. Analytic Framework for the Diagnosis and Treatment of Erectile DysfunctionEndocrine disordersHypogonadismHyperprolactinemiaAdrenal glands diseaseDiabetesVascular disordersCongestive heart failureCoronary artery diseaseCerebrovascular diseaseHypertensionNeurogenicSpinal cord injuryParkinson’s diseasePsychogenicDepressionIatrogenicProstatectomyBenign prostatichyperplasiaProstate cancer18
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
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Page 36 and 37: Prevalence of Hypogonadism (Total S
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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
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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
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Sublingual Treatments - Apomorphine
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been taking over the past two or fo
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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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(117) Carrier S, Brock GB, Pommervi
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Anonymous. Surgery & watchful waiti
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Baker Christine D. A cognitive-beha
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Bayes M, Rabasseda X, Prous J R. Ga
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Bhatnagar V, Stewart S T, Huynh V e
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Boswell-Smith V, Spina D, Page C P.
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Burke J P, Jacobson D J, McGree M E
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Carson C C. Combination of phosphod
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Chen Y. Acupuncture treatment of fu
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Cooke B M, Breedlove S M, Jordan C
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Daitch J A, Angermeier K W, Lakin M
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Derouet H, Jost W H, Osterhage J et
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Doust J, Miller E, Duchesne G et al
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Elhilali M M. Alfuzosin: An a1-rece
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Ferri C, Giuggioli D, Cazzato M et
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Frucht S J. Parkinson disease: An u
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Ghofrani H A, Pepke-Zaba J, Barbera
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Baldwin D S. Sexual dysfunction ass
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Douglass M A, Lin J C. Update on th
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Hatch J P. Psychophysiological aspe
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Lau D H, Mumtaz F H, Thompson C S e
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Morales A, Heaton J P. Hormonal ere
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Roehrborn C G, McNicholas T. The Ma
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Uckert S, Stief C G, Jonas U. Curre
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Leungwattanakij S, Flynn V, Hellstr
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Musacchio Najah S, Hartrich Molly,
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Akkus E, Kadioglu A, Esen A et al.
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Ashok S, Sigman M. Bioavailable tes
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Briganti A, Salonia A, Gallina A et
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Chinegwundoh F, Anie K A. Treatment
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Dundar S O. Visual loss associated
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Giammusso B, Gattuso U, Vanaclocha
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Hawton Keith, Catalan Jose, Fagg Jo
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Kell P. Cardiovascular safety of si
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Laumann Edward O, West Suzanne, Gla
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Matthew A G, Goldman A, Trachtenber
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Mulhall J P. Deciphering erectile d
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Parsons J K, Marschke P, Maples P e
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Rojewski M T, Korper S, Schrezenmei
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Shabsigh R. Testosterone therapy in
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Tam S W, Worcel M, Wyllie M. Yohimb
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Webb D J, Freestone S, Allen M J et
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Katlowitz N M, Albano G J, Morales
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Sparwasser C, Treiber U, Bahren W e
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van Basten J P, Van Driel M F, Jonk
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Youssef A F, Fort F L, Ronsen B et
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Cooper A J. Evaluation of I-C papav
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Isidori A M, Giannetta E, Gianfrill
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Armstrong D K, Convery A, Dinsmore
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Buvat J, Montorsi F. Safety and tol
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Kim E D, McVary K T. Topical prosta
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Lundberg L, Olsson J-O, Kihl B. Lon
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Moncada I, Jara J, Subira D et al.
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Shabsigh R. Hypogonadism and erecti
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Terradas C, Levalle O, Nagelberg A
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Yenicerioglu Y, Kefi A, Aslan G et
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Anonymous. New erectile dysfunction
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Bolona E R, Uraga M V, Haddad R M e
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Chen J, Greenstein A, Kaver I et al
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Derby C A, Barbour M M, Hume A L et
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Foulks C J, Cushner H M. Sexual dys
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Hamed S, Mohamed K, El-taher A et a
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Jeong S-J, Park K, Moon J-D et al.
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La Pera G, Franco Giannotti C, Tagg
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Mann R D. Introduction - Tadalafil.
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Montorsi F, Burnett A L. Erectile d
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Ozdel O, Oguzhanoglu A, Oguzhanoglu
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Ramasubbu Rajamannar. Switching to
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Schwartz E J, Wong P, Graydon R J.
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Stolk E A, Busschbach J J, Caffa M
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Vitezic D. A risk-benefit assessmen
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Knispel H H, Huland H. Influence of
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Kloner R A, Mitchell M, Emmick J T.
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Anonymous. Diagnostic and therapeut
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The UO-EPC gratefully acknowledges
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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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