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C-241 AuthorFundingN; study design;eligibilityParticipantscharacteristicsDiagnosis details Intervention OutcomesGeorgitis, W. N screened = NR Age: Mean IG1: 59.1 ± Concomitant IG1: Oral Primary outcome results:(1995) 250 N randomized = NRIG1, n = 346.4Mean CG: 64.6 ± 7.6Race: (n)medications: NRDuration of ED: IG1vs CG:Pentoxifylline(Trental)CG: PlaceboSelf reported EF: IG1 vs CG: NodifferenceFrequency of nocturnal penileFunding CG, n = 26 Black: 20; Hispanic: 5; 5.2 ± 3.8 vs 6.0 ± 5.0 tumescence IG1 vs CG: No differencesource: U.S. White: 35 Underlying disease IG1: Pentoxifylline Frequency of attempted intercourse orArmy Health ITT analysis used for Co-morbidities (diagnosis): Dose: 400 mg desired intercourse IG1 vs CG: NoServices primary outcome: NR (unrelated to disease): Diabetes Duration: 3 mo differenceCommandInclusion: Non insulindependentDM menPatients with fastingserum glucose >200mg/dl or HbA 1c >10%included only ifimpotence persistedafter improved glycemiccontrolFrequency: 3/dayCompliance (%): NRCG: PlaceboDose: N/ADuration: 3 moFrequency: 3/dayCompliance (%): NRExclusion: Patientsreceivinganticoagulants, withpast Hx of peptic ulcerdisease or whoseimpotence was notcause by diabetes.Patients on betablockers,aldomet orclonidine excludedNRBlood glucose (orHbA1C): Initial: IG1 vs.CG: 8.1 ± 1.8 vs. 7.4±1.5. End: 8.0 ± 1.7 vs.7.2 ± 1.3Previous EDtreatment: NRBMI (kg/m 2 ): Mean IG1vs. CG:28.0 ± 4.2 vs. 28.5 ± 3.0Smoking status: IG1vs. C: Active 3 vs. 8;Quit: 15 vs. 19;Nonsmokers: 8 vs.7 Pack yrs: 39 ± 5 vs.37 ±9Body weight: NRDuration (yrs):IG1:13.6 ± 8.7CG: 14.2 ± 10.9Psychogenic ED:NRPhysiologic ED: NRMixed ED: NROther: Treatment fordiabetes, IG1 vs CG:Diet:3 vs 0. Oral:18vs 12. Insulin:13 vs 9.Combination: 0 vs 2Onset of ED,gradual/abrupt IG1 vsCG: 31/3 vs 24/2Duration ofhypertension, IG1 vsCG:16.6 ± 12.6 vs10.9 ± 8.6 yrsAnkle brachial SBPratios abnormal in 6%of IG1 vs 0% CGPenile brachial bloodpressure rationsabnormal in 38& ofIG1 vs 27% CGAutonomicdysfunction in IG1 vsCG: 82% vs100%.Run In period: NRWash out period:NRF/u duration (on andoff treatment): 3 moOther: NROther outcomes assessed:Rigidity, change in tumescence, erectileevents /night, all abnormal in both IG1and CG at baseline: No improvementobserved in both IG1 and CG after 3 moWithdrawals/drop-outs/loss to f/u:NRWDAE: NRTAE: NRSAE: NRAscertainment of outcomesassessed:Self assessed EF using questionnaireand Likert scale at 3 time pointsNocturnal penile tumescence:Monitored at 3 time points before andafter intervention using RigiScanmonitor.Peripheral vascular measurementsdone by Doppler ultrasound usingModel 1059 Mini-lab III and a PVR IVPulse Volume recorder
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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-146 C5-Intracavernousal Injection
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C-202 C8-Topical Treatments of ED 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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Bella A J, Brock G B. Tadalafil: A
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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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