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StudyAdverse EventsTrimix vs. Trimix + Sodium BicarbonateTreatment Control Absolute RiskGroup Group Difference% (n/N) % (n/N) [95% CI]Moriel 1993 Pain/discomfort 57.9 (11/19) 5.3 (1/19) 53.0 [28.0–77.0]Trimix vs. Trimix + AtropineSogari 1997 Pain 50.0(57/114)Papaverine +Phentolamine vs. PlaceboBechara 1997Pain15.0 (9/60)55.3(63/114)0-5.0 [-18.0, 8.0]–Prolonged erection18.3 (11/60)0–Papaverine + Phentolamine + Sexual Counseling vs. Papaverine + PhentolamineVan der Windt200212% discontinued because of prolonged erectionPriapism: 3 patientsHematoma: 4 patientsCurvature of the penis: 1 patientAE similar between groups–Papaverine vs. MoxisylateKunelius 1998 Prolonged erection 6.7 (2/30) 3.3 (1/30) 3.0 [-8.0, 14.0]Moxisylate vs. PlaceboCosta 1993Prolonged erection1.6 (1/61)0–Mild pain3.3 (2/61)0–Faintness (normal BP)3.3 (2/61)0–Hypotension, nausea, orbradycardia1.6 (1/61)0–Hot flushes1.6 (1/61)0–Vagal shock after sharppain during injection01.6 (1/61)–Vasoactive Intestinal Polypeptide + Phentolamine vs. PlaceboSandhu 1999BruisingBleeding at injection site43.1 (84/195)20.5 (40/195)12.3(24/195)5.1 (10/195)31.0 [22.0–39.0]15.0 [9.0–22.0]148
StudyAdverse EventsTreatment Control Absolute RiskGroup Group Difference% (n/N) % (n/N) [95% CI]Pain on injection 4.6 (9/195) -4.0 [-8.0, 1.0]8.2 (16/195)Urethral bleeding 12.3 (24/195) 10.0 [5.0–15.0]2.6 (5/195)Priapism <1.0 (1/195) –0Flushing 74.4 61.0 [53.0–69.0](145/195) 13.3Headache (26/195) 2.0 [-1.0, 5.0]3.6 (7/195)Palpitation 1.5 (3/195) –7.7 (15/195)Tachycardia 0 5.0 [1.0–8.0]5.1 (10/195)<1.0 (1/195)Timing of PgE1PgE 1 (early intervention) vs. PgE 1 (late intervention): post non–nerve-sparing radicalprostatectomyGontero 2003 Prolonged erection 8.3 (3/36) 0 (0/37) –PgE 1 vs. No Treatment: post–nerve-sparing radical retropubic prostatectomyMontorsi 1997)Prolonged erection6.7 (1/15)0 (0/15)–Hematoma13.3 (2/15)0 (0/15)–PgE 1 + Sexual Counseling vs. PgE 1 : post–nerve-sparing radical retropubic prostatectomyor cystectomyTitta 2006 Moderate pain 34.5 (10/29) 42.9 (12/28) -8.0 [-34.0, 17.0]Severe pain 13.8 (4/29) 10.7 (3/28) 3.0 [-14.0, 20.0]Prolonged erection 17.2 (5/29) 17.8 (5/28) -1.0 [-20.0, 19.0]Hematoma 6.9 (2/29) 10.7 (3/28) -4.0 [-19.0, 11.0]Priapsim 0 0 –Nodule 0 0 –Vasoactive Intestinal Polypeptide + Phentolamine (2 arms) vs. PlaceboDinsmore 1999 Bruising 5.5–7.2(range)5.1–Bleeding at injection site 4.0–4.6(range)3.0 –149
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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
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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 and 172: Table 14: Intracavernosal Injection
Page 173: StudyAdverse EventsTreatmentGroup%
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
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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 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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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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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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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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Buvat J, Montorsi F. Safety and tol
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Shabsigh R. Hypogonadism and erecti
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Terradas C, Levalle O, Nagelberg A
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Anonymous. New erectile dysfunction
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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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