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Appendix B. Data Assessment, Data Abstraction andQuality Assessment FormsLevel 1: Title and Abstract ScreeningScreening Forms1. Is this a potentially relevant record addressing 1. the benefits or harms (note:only SRsexamining Viagara studies for harms data to be included; all other drugs include originalstudie for harms) of a pharmaceutical treatment (oral, topical, intraurethral, injectable, orintracavernosal) for male erectile dysfunction? OR 2. the sensitivity or specificity oftestosterone/LH/FSH/prolactin in identifying a glandular disorder as a cause of ED OR 3. theprevalence of a hormonal (testosterone/LH/FSH/prolactin) disorder in association with maleerectile dysfunction?• Yes• No• Can’t tell2. Please indicate which of the following best describes the current record –• Original study• Narrative review• Systematic review/meta-analysis• Guideline• Comment/Opinion piece• Letter to the editor• Can’t tell3. Is this an English Language Record? (this question is optional)• Yes• No• Can’t tellLevel 2: Full Text Relevance Screening1. Which of the following best describes the attached record: (please check all thatapply) A study examining the measurement of testosterone and/or other androgen hormone,FSH, LH, Prolactin (but not GnRH, Inhibin, Activin, or Follistin) OR the sensitivityor specificity of hormones in ED screening/diagnosing OR prevalence of reversiblehormonal disorders in males with erectile dysfunctionA study examining an oral medication in the treatment of [efficacy/effectiveness (forall drugs) and/or harm outcomes] in male erectile dysfunction in relevant a population(if yes; please indicate in the text box if this is a viagra monotherapy study)B-1
A systematic review of harms associated with ViagraA study examining an intramuscular injectable medication in the treatment of maleerectile dysfunctionA study of an injectable medication into the penis (intracavernosal) OR intraurethralpellet (alprostadil/MUSE, misoprostol, enprostil, arbabprostil, unoprostone) in thetreatment of male erectile dysfunctionA study examining a topical (patch or cream) or intranasal medication in the treatment of male erectile dysfunction None of the above (e.g., not relevant, animal study, etc.)Can't tellA study that examines any harm(s) (e.g., priapism; penile fibrosis/corporal fibrosisonly) for injectable medications in males with ED (Note: treatment and/or f/u must beof >=6 months in duration)A study that examines any harm(s) (e.g., priapism; penile fibrosis/corporal fibrosisonly) for injectable medications in males with ED - treatment and/or f/u of less than 6months in durationA study with treatment and/or f/u >= 6 months in duration that DOES NOT examineharm(s) for injectable medications in males with ED2. Level of Evidence for this report: Systematic Review RCT parallel design, RCT cross-over, or RCT factorial design Controlled clinical trial (non-RCT) Multiple prospective cohort(s) Case-control Cross-sectional Before-and-after Single prospective cohort Single retrospective cohort Case series (non-comparative) Case study B-2
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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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Page 237 and 238: in men with erectile dysfunction. J
Page 239 and 240: parameters in obese men with erecti
Page 241 and 242: comparative crossover study. Androl
Page 243 and 244: 153. Shabsigh R. Efficacy of silden
Page 245 and 246: 190.191.Stief C, Porst H, Saenz dT,
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Page 249 and 250: randomized trial. J Urol 1997 Oct;1
Page 251 and 252: moderate and severe ED. Int J Impot
Page 253 and 254: 349.350.351.randomized, placebo-con
Page 255 and 256: 395. Moher D, Schulz KF, Altman DG.
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Page 274 and 275: The Quality Assessment of Studies o
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C-24 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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(219) Gomaa A, Shalaby M, Osman M e
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(255)(256)dysfunction. Psychopharma
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Adams Henry E, Motsinger Patrice, M
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Althof S E, Turner L A, Levine S B
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Anonymous. Surgery & watchful waiti
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Baker Christine D. A cognitive-beha
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Bayes M, Rabasseda X, Prous J R. Ga
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Bhatnagar V, Stewart S T, Huynh V e
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Boswell-Smith V, Spina D, Page C P.
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Burke J P, Jacobson D J, McGree M E
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Carson C C. Combination of phosphod
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Chen Y. Acupuncture treatment of fu
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Cooke B M, Breedlove S M, Jordan C
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Daitch J A, Angermeier K W, Lakin M
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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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Ghofrani H A, Pepke-Zaba J, Barbera
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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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Rojewski M T, Korper S, Schrezenmei
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Shabsigh R. Testosterone therapy in
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Tam S W, Worcel M, Wyllie M. Yohimb
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Webb D J, Freestone S, Allen M J et
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Katlowitz N M, Albano G J, Morales
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Sparwasser C, Treiber U, Bahren W e
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van Basten J P, Van Driel M F, Jonk
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Youssef A F, Fort F L, Ronsen B et
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Cooper A J. Evaluation of I-C papav
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Isidori A M, Giannetta E, Gianfrill
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Armstrong D K, Convery A, Dinsmore
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Buvat J, Montorsi F. Safety and tol
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De Rose A F, Giglio M, Traverso P e
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Gana T E, Quizanos L F, Castell R e
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Hatzichristou D G, Apostolidis A, T
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Kim E D, McVary K T. Topical prosta
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Lundberg L, Olsson J-O, Kihl B. Lon
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Moncada I, Jara J, Subira D et al.
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Ohebshalom M, Parker M, Guhring P e
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Rajpurkar A, Dhabuwala C B. Compari
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Shabsigh R. Hypogonadism and erecti
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Terradas C, Levalle O, Nagelberg A
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Yenicerioglu Y, Kefi A, Aslan G et
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Anonymous. New erectile dysfunction
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Bolona E R, Uraga M V, Haddad R M e
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Chen J, Greenstein A, Kaver I et al
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Derby C A, Barbour M M, Hume A L et
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Foulks C J, Cushner H M. Sexual dys
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Hamed S, Mohamed K, El-taher A et a
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Jeong S-J, Park K, Moon J-D et al.
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La Pera G, Franco Giannotti C, Tagg
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Mann R D. Introduction - Tadalafil.
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Montorsi F, Burnett A L. Erectile d
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Ozdel O, Oguzhanoglu A, Oguzhanoglu
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Ramasubbu Rajamannar. Switching to
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Schwartz E J, Wong P, Graydon R J.
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Stolk E A, Busschbach J J, Caffa M
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Vitezic D. A risk-benefit assessmen
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Bancroft J, Smith G, Munoz M et al.
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Knispel H H, Huland H. Influence of
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Padma-Nathan H, Eardley I, Kloner R
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Bai W J, Zhu J C, Jiang H et al. [A
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Carosa E, Martini P, Brandetti F et
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Doggrell S A. Comparison of clinica
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Gingell C, Buvat J, Jardin A et al.
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Heaton J P, Morales A, Adams M A et
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Kloner R A, Mitchell M, Emmick J T.
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Marks L S, Duda C, Dorey F J et al.
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Montorsi F, Guazzoni G, Bergamaschi
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Padma-Nathan H, Goldstein I, Klimbe
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Reznik I, Zemishlany Z, Kotler M et
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Shamloul Rany, Kamel Ihab, E-Mail A
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Tsujimura A, Yamanaka M, Takahashi
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Zippe C D, Kedia A W, Kedia K et al
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Anonymous. Diagnostic and therapeut
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Briganti A, Chun F K H, Salonia A e
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Clough J. CNS-targeted sexual dysfu
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Emilien G. Alprox-TD NexMed Inc. Cu
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Gryglewska B, Grodzicki T. Betaxolo
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Kadioglu A, Erdogru T, Tellaloglu S
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Lebret T, Herve J M, Gorny P et al.
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Mealy N E. GPI-1485. Drugs of the F
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O'Sullivan J D. Apomorphine as an a
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Riley Alan. Oral treatments for ere
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Silvestri A, Galetta P, Cerquetani
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Unnikrishnan A G, Rajaratnam S, Ses
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Zhao L. Clinical observation on the
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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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