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Evidence Report/Technology AssessmentNumber 171Diagnosis and Treatment of Erectile DysfunctionPrepared for:Agency for Healthcare Research and QualityU.S. Department of Health and Human Services540 Gaither RoadRockville, MD 20850www.ahrq.govContract No. 290-02-0021Prepared by: University of Ottawa Evidence-based Practice Center, Ottawa, Canada InvestigatorsAlexander Tsertsvadze, M.D., M.Sc. Fatemeh Yazdi, M.Sc. Howard A. Fink, M.D., Ph.D. Roderick MacDonald, M.S. Tim J.Wilt, M.D. Karla Soares-Weiser, M.D., Ph.D. Anthony J. Bella, M.D. Dan Deforge, M.D. Chantelle Garritty, M.Sc.(c) Mohammed Ansari, M.D., M.Sc. Margaret Sampson, M.L.I.S. Raymond Daniel, B.A. David Moher, Ph.D. AHRQ Publication No. 08(09)-E016May 2009i
This document is in the public domain and may be used and reprinted without permission exceptthose copyrighted materials noted for which further reproduction is prohibited without thespecific permission of copyright holders.Suggested Citation:Tsertsvadze A, Yazdi F, Fink HA, MacDonald R, Wilt TJ, Soares-Weiser K, Bella AJ, DeforgeD, Garritty C, Ansari M, Sampson M, Daniel R, Moher D. Diagnosis and Treatment of ErectileDysfunction. Evidence Report/Technology Assessment No.171 (Prepared by the University ofOttawa Evidence-based Practice Centre (UO-EPC) under Contract No. 290-02-0021). AHRQPublication No. 08(09)-E016, Rockville, MD: Agency for Healthcare Research and Quality. May2009.No investigators have any affiliations or financial involvement (e.g. employment,consultancies, honoraria, stock options, expert testimony, grants or patents received orpending, or royalties) that conflict with material presented in this report.ii
Page 1: This report is based on research co
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 30 and 31: KQ 3. Harms of pharmaceutical treat
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
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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
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Oral Treatments — Phosphodiestera
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The approximate proportion of smoke
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value was not reported). Even thoug
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Tadalafil (20 mg) versus tadalafil
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scheduled dosing regimen (90 percen
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Proportion of patients with improve
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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,
Page 125 and 126:
PhentolamineEfficacy. The results i
Page 127 and 128:
Question 2a-b: Do Specific Patient
Page 129 and 130:
Methodological and Logistic Limitat
Page 131:
Tables and Figures.Summary TablesTa
Page 135:
123Study details 1 Study Design Set
Page 139:
125Table 2: Prevalence of Hypogonad
Page 143:
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
Page 159:
135StudyEDDetails 8 Study Design Se
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Table 10: Serious Adverse Events in
Page 165 and 166:
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
Page 181 and 182:
Physiologic:60.0 (18/30) 90.0 (27/3
Page 183 and 184:
StudyAdverse EventTreatmentGroup% (
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TreatmentStudy ED Etiology Group% (
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StudyAdverse EventCavallini 1991 Pa
Page 189 and 190:
Study/patient CharacteristicsGooma
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Aversa 2003Men witharteriogenicEDYa
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Study/patientCharacteristicsClopper
Page 195 and 196:
Study/patientCharacteristicsOutcome
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Table 26: Testosterone Treatment: P
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McNicholas2002Patients reporting
Page 201:
175Table 27: Miscellaneous Treatmen
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177Table 28: Nonarteritic Anterior
Page 209 and 210:
Table 29: Penile Fibrosis in Studie
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StudyStudyDesignPatientsage range 4
Page 213 and 214:
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,
Page 247 and 248:
treatment of men with erectile dysf
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randomized trial. J Urol 1997 Oct;1
Page 251 and 252:
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)
Page 263 and 264:
27. limit 26 to yr="1990 - 2008"28.
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5. exp clinical trials/6. random$.m
Page 267 and 268:
20. or/17-1921. 16 and 2022. limit
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A systematic review of harms associ
Page 271:
B-4Summary Table- Randomized Contro
Page 274 and 275:
The Quality Assessment of Studies o
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AuthorFundingN; study design; eligi
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C-10 AuthorFundingN; study design;
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C-146 C5-Intracavernousal Injection
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C-202 C8-Topical Treatments of ED A
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C-216 C9-Testosterone Treatment of
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men with erectile dysfunction and s
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symptoms associated with benign pro
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(84) Zinner N. Do food and dose tim
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(117) Carrier S, Brock GB, Pommervi
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(150) Hagemann JH, Berding G, Bergh
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(183) Moriel EZ, Rajfer J. Sodium b
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(219) Gomaa A, Shalaby M, Osman M e
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(255)(256)dysfunction. Psychopharma
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Anonymous. Surgery & watchful waiti
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Chen Y. Acupuncture treatment of fu
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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
Page 844 and 845:
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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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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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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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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Montorsi F, Burnett A L. Erectile d
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Ramasubbu Rajamannar. Switching to
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Schwartz E J, Wong P, Graydon R J.
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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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Bai W J, Zhu J C, Jiang H et al. [A
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Padma-Nathan H, Goldstein I, Klimbe
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Reznik I, Zemishlany Z, Kotler M et
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Shamloul Rany, Kamel Ihab, E-Mail A
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Anonymous. Diagnostic and therapeut
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Riley Alan. Oral treatments for ere
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Zhao L. Clinical observation on the
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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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