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Treatment Control Relative RiskStudy ED etiology GroupGroup[95% CI]% (n/N)% (n/N)Mixed: 28% 81.3 (61/75)InvestigatorassessmentPgE 1 vs. Nitroprusside (300 µg or 400 µg)Martinez-Piñeiro 1995NRPgE 1 vs. LinsidominePorst 1993 Psychogenic: 60%Physiologic: 40%45.7 (37/81)Investigatorassessment20.0 (12/60) 15.0 (9/60)300 µg20.0 (7/35) 14.3 (5/35)400 µg1.78 [1.37–2.31]1.33 [0.61–2.93]1.40 [0.49–3.99]65.0 (26/40) 12.5 (5/40) 5.20 [2.22–12.18]Wegner 1995 NR 40.0 (16/40) 7.5 (3/40) 5.33 [1.68–16.89]Wegner 1994 NR 30.0 (6/20) 10.0 (4/40) 3.00 [0.95–9.43]Range of treatment improvement (%) 30.0–65.0 7.5–12.5 NAPgE 1 vs. Linsidomine + UrapidilWegner 1995 NR 40.0 (16/40) 25.0 (10/40) 1.60 [0.83–3.09]PgE 1 vs. PgE 1 + LidocaineKattan 1995PgE 1 vs. PgE 1 + ProcaineNRDM: 68%Low testosterone: 12%Shramek 1994 Psychogenic: 12.5%Physiologic: 87.5%27.3 (6/22) 63.6 (14/22) 0.43 [0.20–0.91]66.7 (16/24) 66.7 (16/24) 1.00 [0.67–1.49]Trimix vs. Trimix + Sodium BicarbonateMoriel 1993 NR 68.4 (13/19) 78.9 (15/19) 0.87 [0.59–1.27]Trimix vs. Trimix + AtropineSogari 1997NRRisk factors: DM,hypertension, alcoholism,smoking, Peyronie’sdisease)45.6 (52/114) 45.6 (52/114) –Papaverine + Phentolamine vs. Placebo142
Treatment Control Relative RiskStudy ED etiology GroupGroup[95% CI]% (n/N)% (n/N)Bechara 1997 NR 56.7 (34/60) 0 (0/60) –Papaverine + Phentolamine + Sexual counseling vs. Papaverine + PhentolamineVan der Windt2002Psychogenic: 35.7%Physiologic: 11.4%Mixed: 34.3%84 (subjectiveerection score,range 0–100)PgE 1 + Papaverine vs. Papaverine + PhentolamineFloth 1991 Psychogenic: 12.3%Physiologic: 100%(Patients could haveboth)Papaverine vs. Moxisylate79 (subjectiveerection score,range 0–100)77.6 (38/49) 57.1 (28/49) 1.36 [1.02–1.81]Kunelius 1998 NR 10.0 (3/30) 7.0 (2/30) 1.50 [0.27–8.34]–Moxisylate vs. PlaceboCosta 1993 Psychogenic: 32% 86.9 (53/61) 27.9 (17/61) 3.12 [2.06–4.72]Vasoactive Intestinal Polypeptide + Phentolamine vs. PlaceboSandhu 1999 Physiologic: 47%Mixed: 53%(Dose assessmentphase)Results: Phase 1-2combined.Phase 1 criteria met by133 patients and phase 2criteria met by 126patients (94.7%)ITT population: 172 of195 of those whoreceived at least oneinjection of activetreatment and placeboErectionssuitablefor intercourse25 µg dose:75.1%(1417/1886injections)2 mg dose:66.5% (257/386injections)ITT analysis25 µg dose:73.7%(1576/2137injections)2 mg dose:69.1% (397/574injections)Erectionssuitablefor intercourse25 µg dose:12.1% (45/373injections)2 mg dose:10.3% (8/78injections)ITT analysis25 µg dose:12.9% (55/426injections)2 mg dose:13.7% (16/116injections)p <0.001p <0.001p <0.001p <0.001Timing of PgE1 and/or use in post-prostatectomy populationsPgE 1 (early intervention) vs. PgE 1 (late intervention): post non–nerve-sparing radical prostatectomyGontero 2003 All men had prostatecancer†72.2 (26/36) 43.2 (16/37) 1.67 [1.10–2.54]143
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This report is based on research co
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This document is in the public doma
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AcknowledgmentsThe authors would li
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ContentsExecutive Summary..........
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Table 17: Intra-urethral Treatment:
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Figure 63. Absolute Mean Change Fro
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associated with ED treatments. Two
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ED as a main complaint. In only one
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different formulations/modes of app
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Evidence Report
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flaccidity are no less important th
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prostatectomy, antipsychotic agents
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disease). Furthermore, there is ins
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Analytic FrameworkFigure 1. Analyti
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KQ 3. Harms of pharmaceutical treat
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Figure 2. Modified QUOROM Flow Char
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that included intervention characte
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Prevalence of Hypogonadism (Total S
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stimulation and a challenge test wi
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Overview of Trials79-84,86-88,90,91
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131,137,138,142,143,147,151,155,156
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pectoris occurred in a participant
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statistical test results for the ob
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individual Q1-Q15 items, 104,106,15
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Proportion of participants with hea
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erectile maintenance frequency, IIE
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Oral Treatments — Phosphodiestera
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Patients were instructed to take th
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Results obtained from two trials 19
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improved erections was higher in pa
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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
Page 117 and 118: Question 1: What is the Clinical Ut
Page 119 and 120: Questions 2-3: What are the Benefit
Page 121 and 122: Harms. There were no obvious differ
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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
Page 147: 129Table 4: Prevalence of Hypogonad
Page 151: 131Study Details 5 Study Design Set
Page 155: Table 7: Prevalence of Hyperprolact
Page 159: 135StudyEDDetails 8 Study Design Se
Page 163 and 164: Table 10: Serious Adverse Events in
Page 165 and 166: Table 11: Efficacy Results of Tadal
Page 167: Treatment Control Relative RiskStud
Page 171 and 172: Table 14: Intracavernosal Injection
Page 173 and 174: StudyAdverse EventsTreatmentGroup%
Page 175 and 176: StudyAdverse EventsTreatment Contro
Page 177 and 178: Study / Typeof PatientsOutcome Defi
Page 179 and 180: Study ED Etiology OutcomeWilliams*1
Page 181 and 182: Physiologic:60.0 (18/30) 90.0 (27/3
Page 183 and 184: StudyAdverse EventTreatmentGroup% (
Page 185 and 186: TreatmentStudy ED Etiology Group% (
Page 187 and 188: StudyAdverse EventCavallini 1991 Pa
Page 189 and 190: Study/patient CharacteristicsGooma
Page 191 and 192: Aversa 2003Men witharteriogenicEDYa
Page 193 and 194: Study/patientCharacteristicsClopper
Page 195 and 196: Study/patientCharacteristicsOutcome
Page 197 and 198: Table 26: Testosterone Treatment: P
Page 199 and 200: McNicholas2002Patients reporting
Page 201: 175Table 27: Miscellaneous Treatmen
Page 205: 177Table 28: Nonarteritic Anterior
Page 209 and 210: Table 29: Penile Fibrosis in Studie
Page 211 and 212: StudyStudyDesignPatientsage range 4
Page 213 and 214: Figure 6. Improved erection (GEQ-Q1
Page 215 and 216: Figure 11. Visual disturbances (all
Page 217 and 218: 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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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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Adams Henry E, Motsinger Patrice, M
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Althof S E, Turner L A, Levine S B
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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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Gana T E, Quizanos L F, Castell R e
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Hatzichristou D G, Apostolidis A, T
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Kim E D, McVary K T. Topical prosta
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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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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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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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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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Montorsi F, Guazzoni G, Bergamaschi
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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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Tsujimura A, Yamanaka M, Takahashi
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Anonymous. Diagnostic and therapeut
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Silvestri A, Galetta P, Cerquetani
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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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