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StudyAdverse EventsPgE 1 vs. Papaverine + PhentolamineTreatmentGroup% (n/N)ControlGroup% (n/N)Prolonged erection 0 10.5 (4/38) –Absolute RiskDifference[95% CI]Bechara 1997 Pain 35.0 (21/60) 15.0 (9/60) 20.0 [5.0–35.0]PgE 1 vs. Phentolamine+ PgE 1Prolonged erection 15.0 (9/60) 18.3 (11/60) -3.0 [-17.0,10.0]Aversa 1996a Prolonged erection 4.2 (1/24) 4.2 (1/24) –PgE 1 vs. TrimixBechara 1996 Pain 40.6 (13/32) 12.5 (4/32) 28.0 [8.0–49.0]Seyam 2005 Pain 17.3 (31/179) 14.4(26/179)-3.0 [-11.0, 4.0]Range of reported pain/discomfort (%) 14.4–40.6 12.5–17.8 NASeyam 2005 Priapism <1.0 (1/179) 5.0 (9/170) -5.0 [-8.0, -1.0]PgE 1 vs. MoxisylateBuvat 1998Pain during injection: clinic13.3 (10/75)14.8 (12/81)-1.0 [-12.0, 9.0]Pain during injection:homePain during erection: clinicPain during erection:home25.0 (17/68)17.3 (13/75)23.5 (16/68)6.7 (5/75)14.8 (9/61)2.5 (2/81)4.9 (3/61)0 (0/81)10.0 [-3.0, 24.0]15.0 [6.0–24.0]19.0 [7.0–30.0]–Pain after erection: clinic19.1 (13/68)4.9 (3/61)14.0 [3.0–25.0]Pain after erection: home5.3 (4/75)0 (0/81)–Prolonged erection: clinic4.4 (3/68)1.6 (1/61)3 .0 [-3.0, 9.0]Prolonged erection: home2.7 (2/75)2.5 (2/81)0.0 [-5.0, 5.0]Bleeding: clinic14.7 (10/68)4.9 (3/61)10.0 [0.0–20.0]Bleeding: home1.5 (1/68)8.2 (5/61)-7.0 [-14.0, 1.0]Dizziness/hypotension:homeKunelius 1998 Prolonged erection 10.0 (3/30) 3.3 (1/30) 7.0 [-6.0, 19.0]PgE 1 vs. Nitroprusside (100 µg, 300 µg or 400 µg)146
StudyAdverse EventsTreatmentGroup% (n/N)ControlGroup% (n/N)Absolute RiskDifference[95% CI]Martinez-Piñeiro1995Pain during injectionDizziness6.7 (7/105)3.8 (4/105)06.7 (7/105)7.0 [2.0–12 .0]-3.0 [-9.0, 3.0]Hematoma1 subject1 subject–PgE 1 vs. LinsidominePorst 1993 Penile pain 17.5 (7/40) NR –Wegner 1995 Pain during injection 7.5 (3/40) 2.5 (1/40) 5.0 [-4.0, 14.0]Range of reported pain/discomfort (%) 7.5–17.5 NA NAPorst 1993Moderate/severeheadachePgE 1 vs. Linsidomine + UrapidilWegner 1995Pain during injectionNR 7.5 (3/40) –7.5 (3/40) 7.5 (3/40) –Serve hypotension012.5 (5/40)–PgE 1 (fast injection) vs. PgE 1 (slow injection)Gherchiu 1996 Pain during injection 54.5 (6/11) 18.2 (2/11) 36.0 [-1.0, 74.0]PgE 1 vs. PgE 1 + Local AnestheticKattan 1995 Pain 86.4 (19/22) 45.4 (10/22)Lidocaine41.0 [16.0–66.0]Shramek 1994 Pain, moderate to severe 83.3 (20/24)(11 patientswith severeED)62.5 (15/24)+ Procaine(4 patientswith severeEDRange of reported pain/discomfort (%) – – NAPgE 1 vs. PgE 1 + Sodium Bicarbonate21.0 [-4.0, 45.0]Godschalk 1996 Pain 80.0 (8/10) 70.0 (7/10) 10.0 [-28.0,48.0]PgE 1 + Papaverine vs. Papaverine + PhentolamineFloth 1991Pain16.3 (8/49)0–Prolonged erection8.2 (4/49)8.2 (4/49)–147
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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
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Question 1: What is the Clinical Ut
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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 and 168: Treatment Control Relative RiskStud
Page 169 and 170: Treatment Control Relative RiskStud
Page 171: Table 14: Intracavernosal Injection
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
Page 219 and 220: Figure 23. The mean IIEF-Q4 score:
Page 221 and 222: 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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Elhilali M M. Alfuzosin: An a1-rece
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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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Sparwasser C, Treiber U, Bahren W e
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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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