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C-147 AuthorFundingN; study design;eligibilityParticipantscharacteristicsDiagnosis details Intervention OutcomesAversa (1996)157A: (single-blindtrial)Funding source:NRN screened = NRN randomized = 24(cross over)IG1/IG2, n = 24CG, n = NAITT analysis used forprimary outcome: NRInclusion: pts 20-45 yrswith non-organic ED => 6mo duration (inability tachieve or maintainadequate erection forsuccessful coitus), normaltesticular size, noconcomitant disease, norecent hx of drug abuse,normal cella turcicaroentgenograms, normalresults of neurological,vascular and clinicalchemistry (3h glucosetolerance, liver and renalfunction tests), and normalbasal serum levels (PRL <25 ng/ml, testosterone>653 nmol/l)Exclusion: NRAge, range: NR(20-45) yrs (basedon total samplefrom 2 separatetrials (study a andb)Co-morbidities:NRPrevious EDtreatment: NRSmoking status:n=18 (total in 2separate trialsBody weight: NRConcomitantmedications: NRDuration of ED (yr):=> 6 moUnderlyingdisease: NRPsychogenic ED:100%Physiologic ED:NoneMixed ED: NRIG1: PgE1IG2: PgE1 +phentolamineIG1:Dose: 20 μg/mlDuration: NAFrequency: onceCompliance: NRIG2:Dose: 20 μg/ml (PgE1)0.5 μg/ml(phentolamine)Duration: NAFrequency: onceCompliance: NRRun In period: 12 hr(no smoke, no coffee)Wash out period: 7 dF/u duration: 7 d(assessments done 15min after the injections)Primary outcome results:N (%) pts with full response (IG1 vs.IG2) =5 (21%) vs. 13 (54%), p < 0.05N (%) pts with partial response (IG1 vs.IG2) = 10 (42%) vs. 8 (33%), p = NR% pts with a valid-for-intromissionerection (IG1 vs. IG2) = 63% vs. 87%, p< 0.05Mean duration of erection (IG1 vs. IG2)= 112 (7.9) vs. 130 (8.5), p = NROther outcomes assessed: level ofanxietyWithdrawals/drop-outs/loss to f/u:NRWDAE: NRTAE: mild to moderate discomfort in21%; prolonged erection in 2: 1 IG1(4%); 1 in IG2 (4%)Note: % of pts reported for combineddata, n=34SAE: NRAscertainment of outcomesassessed: questionnaires; axial rigidityby tonometer, and radial rigidity byRigiScan
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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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alone. Compared with trimix alone,
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PhentolamineEfficacy. The results i
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Question 2a-b: Do Specific Patient
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Methodological and Logistic Limitat
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Tables and Figures.Summary TablesTa
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123Study details 1 Study Design Set
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125Table 2: Prevalence of Hypogonad
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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
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135StudyEDDetails 8 Study Design Se
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Table 10: Serious Adverse Events in
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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
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Physiologic:60.0 (18/30) 90.0 (27/3
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StudyAdverse EventTreatmentGroup% (
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TreatmentStudy ED Etiology Group% (
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StudyAdverse EventCavallini 1991 Pa
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Study/patient CharacteristicsGooma
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Aversa 2003Men witharteriogenicEDYa
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Study/patientCharacteristicsClopper
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Study/patientCharacteristicsOutcome
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Table 26: Testosterone Treatment: P
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McNicholas2002Patients reporting
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175Table 27: Miscellaneous Treatmen
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177Table 28: Nonarteritic Anterior
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Table 29: Penile Fibrosis in Studie
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StudyStudyDesignPatientsage range 4
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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,
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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-191 C6-Subcutaneous Treatment Tri
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C-195 C7- Intra-urethral Suppositor
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C-237 C10-Off Label Treatments Auth
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References(1) Abdel-Naser MB, Imam
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in Colombia, Ecuador, and Venezuela
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(67) Rendell MS, Rajfer J, Wicker P
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(100) Martin-Morales A, Meijide F,
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controlled study. Urology 2006; 68(
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(166) el-Saleh JC, Keogh EJ, Chew K
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(201) Wessells H, Levine N, Hadley
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with hypogonadal symptoms. Arch Gen
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Appendix D. Reference List of Exclu
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Akduman B, Crawford E D. The PCPT:
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Anderson R U, Wise D, Sawyer T et a
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Atala A, Amin M. Current concepts i
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Barbaree H E, Mewhort D J. The effe
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Bereczky Z, Bolus M, Chetty P et al
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Blaya C, Seganfredo A C, Dornelles
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Brioni J D, Moreland R B, Cowart M
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Campbell S F. Science, art and drug
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Champion H C. Erectile dysfunction
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Chung W S, Choi H K. Erotic erectio
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Crasilneck Harold B. Hypnotic techn
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De Leval J, Boca P, Youssef E et al
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Doggrell S A. Combination of finast
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Eardley I. Optimisation of PDE5 Inh
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Evans M F. Critical appraisal: Lose
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Formenti S C, Lieskovsky G, Simonea
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Garcia-Campayo Javier, Sanz-Carrill
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Gleave M, Qian J, Andreou C et al.
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Carson C C. Erectile dysfunction: E
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Glina S. Testosterone and erectile
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Kalsi J S, Bahadur G, Muneer A et a
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McMahon C G. New treatment options
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Padma-Nathan H. Efficacy and tolera
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Shabsigh R, Rajfer J, Aversa A et a
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Wincze John P, Carey Michael P. Sex
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Tan R S. Novel treatment options fo
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Gupta A, Cohen B H, Ruggieri P et a
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Anonymous. Sildenafil appears safe
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Bella A J, Brock G B. Tadalafil: A
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Carson C C, Burnett A L, Levine L A
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Curran M, Keating G. Tadalafil.[err
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Fagan T C, Buttler S, Marbury T et
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Greenstein A, Plymate S R, Katz P G
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Hunter R H, Joy C B, Kennedy E et a
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Kloner R A, Mitchell M, Emmick J T.
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Long R L, Sherman L S, Lombardi T J
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Miller N, Smolkin M E, Bissonette E
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Nurnberg H, George. Erectile Dysfun
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Porst H, Giuliano F, Glina S et al.
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Salonia Andrea, Briganti Alberto, M
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Solursh Lionel P, Solursh Diane S.
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van Basten J P, Van Driel M F, Hoek
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Yasumoto R, Nishisaka N, Sakakura T
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Chen J, Godschalk M F, Katz P G et
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Hellstrom W J. Vardenafil: a new ap
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Webb D J, Muirhead G J, Wulff M et
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Kim J M, Joh Y D, Huh J D et al. Do
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Tariq S H, Haleem U, Omran M L et a
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Aizenberg Dov, Gur Shay, Zemishlany
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Beretta G, Marzotto M, Zanollo A et
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Cheng E. Real-life safety and effic
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English J C, King D H C, Foley J P.
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Goldstein I, Auerbach S, Padma-Nath
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Jackson G. Sildenafil (Viagra): New
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Lane B Z, Ausmundson S J, Butler R
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McMahon C G. An attempt to standard
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Mulhall J P, Land S, Parker M et al
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Pohanka M, Kanovsky P, Bares M et a
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Ruof J, Graf-Morgenstern M, Mnller
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Sparwasser C, Treiber U, Bahren W e
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Wagner G, Montorsi F, Auerbach S et
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Anderson R A, Martin C W, Kung A W
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Baggaley M R, Hirst J F, Watson J P
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Buvat J, Boujadoue G. Testosterone
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Contreras L N, Masini A M, Danna M
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Engelhardt P F, Daha L K, Zils T et
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Glasser S P. Safety of PDE 5 inhibi
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Holtkamp M, Weissinger F, Meierkord
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Kirby R S. Report from London. Pros
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Lexchin J. New drugs with novel the
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Mealy N E. Avanafil. Drugs of the F
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Nakata M, Takashima S, Kaminou T et
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Phillips B G, Kato M, Pesek C A et
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Saad F, Grahl A S, Aversa A et al.
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Sipski M, Alexander C, Guo X et al.
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Traish A M, Goldstein I, Kim N N. T
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Wilt T J, Fink H A. Is antidepressa
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Price D E, Cooksey G, Jehu D et al.
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Bolona E R, Uraga M V, Haddad R M e
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Anonymous. Sublingual apomorphine:
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Bouloux P. Testim 1% testosterone g
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Christ B, Brockmeier D, Hauck E W e
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Fein R L. Classification of sexual
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Green B G, Martin S. Clinical asses
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John H, Lehmann K, Hauri D. Intraur
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Lee W R. The role of androgen depri
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Mealy N E. Alprostadil cream. Drugs
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Murphy J C, Srinivas S, Terris M K.
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Pommerville P. Drug treatments for
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Saie D J, Sills E S. Hyperprolactin
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Steidle C P, McCullough A R, Kamine
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Weiss J N, Badlani G H, Ravalli R e
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Anonymous. Study shows patients tak
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Bartlik Barbara D, Kaplan Peter, Ka
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Cawello W, Schweer H, Dietrich B et
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Del Popolo G, Li Marzi V, Mondaini
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Gallo L, Perdona S, Autorino R et a
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Hofner K, Claes H, De Reijke T M et
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Kloner R A, Hutter A M, Emmick J T
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Maan Z, Arya M, Shergill I et al. P
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Montorsi F, Strambi L F, Guazzoni G
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Phelps J S, Jain A, Monga M. The Ps
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Sato Y, Suzuki N, Adachi H et al. E
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Strachan M W, Teoh W L, Don-Wauchop
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Weinhardt L S, Carey M P. Prevalenc
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Appendix E. Additional Acknowledgme
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Appendix F. Quality AssessmentRando
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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Jadad Q-1AuthorYearJadad Q-2 Jadad
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Quality Assessment of Observational
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Appendix G. Funnel PlotsSildenafilF
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Figure G-3. Sildenafil (any dose) v
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VardenafilAny dose vs. PlaceboFigur
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Figure G-11. Vardenafil (any dose)
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Figure G-13. Tadalafil (20 mg) vs.
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20 mg vs. 10 mgFigure G-15. Tadalaf
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Appendix H. Instruments Used in the
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1 = Very dissatisfied2 = Moderately
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Appendix I. List of Unobtained Arti
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