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The Quality Assessment of Studies of Diagnostic Accuracy Included in Systematic Reviews(QUADAS)Q1: Was the spectrum of patients representative of the patients who will receive the test inpractice? Yes/noQ2. Were selection criteria clearly described? Yes/noQ3. Is the reference standard likely to correctly classify the target condition? Yes/noQ4. Is the time period between reference standard and index test short enough to bereasonably sure that the target condition did not change between the two tests? Yes/noQ5. Did the whole sample or a random selection of the sample, receive verification using areference standard? Yes/noQ6. Did patients receive the same reference standard regardless of the index test result? Yes/noQ7. Was the reference standard independent of the index test (i.e. the index test did not formpart of the reference standard)? Yes/noQ8. Was the execution of the index test described in sufficient detail to permit replication ofthe test? Yes/noQ9. Was the execution of the reference standard described in sufficient detail to permit itsreplication? Yes/noQ10. Were the index test results interpreted without knowledge of the results of the referencestandard? Yes/noQ11. Were the reference standard results interpreted without knowledge of the results of theindex test? Yes/noQ12. Were the same clinical data available when test results were interpreted as would beavailable when the test is used in practice? Yes/noQ13. Were uninterpretable/ intermediate test results reported? Yes/noQ14. Were withdrawals from the study explained? Yes/noB-6
Appendix C. Evidence TablesC1-Oral SildenafilAuthorFundingN; study design; eligibilityParticipantscharacteristicsDiagnosis details Intervention OutcomesAbdel-Naser(2004) 1Fundingsource: PfizerN screened = NRN randomized = 30IG1, n = 15IG2, n = 15CG, n = 12 (normal men)Intention to treat (ITT)analysis: NRInclusion: men withpsychogenic ED (noresponse to sildenafil citrateof up to 100 mg in more thanone occasion within a onemo); also non-sildenafiltreated pts with ED servedas controlExclusion: penileanatomical defects, activepeptic ulcer, bleeding dx,retinitis pigmentosa, majorhaematological renal orhepatic abnormalities; hx ofstroke or recent MI; loss oflibido; use ofanihypertensives, nitrates,tranquilizers or drugs knownto interfere with sildenafilcitrate metabolism (e.g.cimetadine & ketoconazol)Age, mean (sd):42.5 (6.7) y, range34-58 yRace (%): NRCo-morbidities:NRPrevious EDtreatment: 100%with Sidenafil, 100mgSmoking status:NRConcomitantmedications: NRDuration of ED: NRUnderlyingdisease: NRPsychogenic ED:100%Physiologic ED: 0Mixed ED: 0IG1: sildenafil citrate(night 3) & placebo(nights 1,2 & 4)IG2: sildenafil citrate(night 4) & placebo(nights 1, 2, & 3)CG: placebo (all nights)IG1:Dose: 50 mgDuration: 4 nightsFrequency: once, 1 hrbefore bedtime/ nightCompliance (%): NRIG2:Dose: as IGDuration: 4 nightsFrequency: as IGCompliance (%): NRCG:Dose: NADuration: 4 nightsFrequency: once/nightCompliance (%): NRRun In period: NRWash out period: NRF/u duration: NRPrimary outcome results:NPTR for basal condition, mean (sd)placebo nights vs. sildenafil nightNumber of eventsIG1 4.7 (1.4) vs. 6.7 (1.6)IG2: 3.8 (1.2) vs. 7 (1.2)Total event duration, hr:IG: 1.4 (0.2) vs. 2.1 (0.4)IG2: 1.3 (0.2) vs. 2.4 (0.2)Tip rigidityIG1: 39.7 (9.5) vs. 47.8 (10.4)IG2: 44.3 (10.3) vs. 57.6 (10.7)Base rigidity:IG1: 45.1 (8.8) vs. 57.3 (10.5)IG2: 49.4 (10.5) vs. 60.8 (11)Other outcomes assessed: base, tipRAU, and TAU (result suggestive ofpossible performance anxiety effect inthis population); no result reported forCGWithdrawals/drop-outs/loss to f/u:NRWDAE: NRTAE, n (%): 3 (10), headache in 2 pts(6.7%), GI upset in 1 (3.3%)SAE: 0Ascertainment of outcomesassessed: RigiScan nocturnal peniletumescence and rigidity (NPTR); RAUand TAUC-1
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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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C-202 C8-Topical Treatments of ED A
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C-216 C9-Testosterone Treatment of
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Roehrborn C G, McNicholas T. The Ma
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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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Briganti A, Salonia A, Gallina A et
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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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