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StudyED etiologyTreatmentGroup% (n/N)ControlGroup% (n/N)PgE 1 vs. No Treatment: post–nerve-sparing radical retropubic prostatectomyMontorsi 1997All men had prostatecancer†Relative Risk[95% CI]66.7 (8/12) 20 (3/15) 3.33 [1.12–9.90]PgE 1 + Sexual Counseling vs. PgE 1 : post–nerve-sparing radical retropubic prostatectomy orcystectomyTitta 2006Men had either prostateand/or bladder cancer†Mean IIEF score26.6 (beforesurgery)Mean IIEF score26.1 (beforesurgery)–8.4 (before ICI)23.4(3 months aftersurgery)26.5(18 monthsafter surgery)8.4 (before ICI)21.7(3 months aftersurgery)24.3(18 monthsafter surgery)–p <0.0575.8 (22/29)No ED at end ofstudy50.0 (14/28)No ED at end ofstudy1.52 [0.99–2.32]* Defined as full erection or “positive response,” Grade 4/5 erections, or erections sufficient for intercourse or Rigiscanassessment ≥70% rigidity base or tip lasting ≥10 minutes** Numbers extracted from graph† All men were potent or had normal International Index of Erectile Dysfunction (IIEF) scores at baseline†† Percentage of sexual situations producing an erection144
Table 14: Intracavernosal Injection: Patients with Adverse EventsStudyAdverse EventsTreatmentGroup% (n/N)ControlGroup% (n/N)Absolute RiskDifference[95% CI]Prostaglandins (PgE 1 ) vs. PlaceboBechara 1997 Pain 35.0 (21/60) 0 –Linet 1996Penile painPriapism22.7(54/237)2.5 (6/237)NRNR––Vanderschueren1995Penile pain 11.7(74/630)10.9(23/210)1.0 [-4.0, 6.0]von Heyden1993Penile pain/burningsensation13.3(18/135)NR –Range of reported pain/discomfort (%) 11.7–35.0 0–10.9 NABechara 1997 Prolonged erection 15.0 (9/60) 0 (0/60) –von Heyden1993Hematoma 1.5 (2/135) NR –Colli 1996 Treatment-related 2.2 (3/135) 2.2 (1/45) –von Heyden1993Treatment-related 16.3(22/135)NR –PgE 1 vs. PapaverineEarle 1990 Pain during injection 8.5 (11/129) 4.7 (6/129) 4.0 [-2.0, 10.0]Kattan 1991 Pain during injection 46.0 (23/50) 44.0 (22/50) 2.0 [-17.0, 21.0]Mahmoud 1992 Penile pain 11.5 (6/52) 32.7 (17/52) -21.0 [-37.0,6.0]Range of reported pain/discomfort (%) 8.5–46.0 4.7–44.0 NAEarle 1990 Prolonged erection 0 <1 (1/129) –Kattan 1991 Priapism 0 0 –Kunelius 1998 Prolonged erection 10.0 (3/30) 6.7 (2/30) 3.0 [-11.0, 17.0]Mahmoud 1992 Priapism 0 0 –Range of prolonged erection/priapism (%) 0–10.0 0–6.7 NAKattan 1991 Dizziness/headache 2.0 (1/50) 4.0 (2/50) -2.0 [-9.0, 5.0]PgE 1 vs. Papaverine + PgE 1Floth 1991 Pain 34.2 (13/38) 18.4 (7/38) 16.0 [-4.0, 35.0]145
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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
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 and 168: Treatment Control Relative RiskStud
Page 169: Treatment Control Relative RiskStud
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
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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
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Page 219 and 220: 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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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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Frucht S J. Parkinson disease: An u
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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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Shabsigh R. Testosterone therapy in
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Webb D J, Freestone S, Allen M J et
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Sparwasser C, Treiber U, Bahren W e
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Cooper A J. Evaluation of I-C papav
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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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