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Study ED Etiology OutcomeTreatmentGroup% (n/N)ControlGroup% (n/N)Alprostadil (titrated; starting dose 250 µg),) vs. Alprostadil (titrated; starting dose 500 µg)Ekman 2000NRVascular: 43%–47%Diabetes: 21%Psychogenic:7%–12%Patients reportingsuccessfulintercourse at leastonceRelativeRisk[95% CI]68.1 (113/166) –Table 18: Intra-urethral Treatment: Improvement in Erections*TreatmentStudy ED etiologyGroup% (n/N)Alprostadil vs. PlaceboPadma-Nathan 1997Physiologic:100%Williams 1998 Physiologic:100%Alprostadil vs. Prazosin (IU)Peterson 1998Physiologic:100%Alprostadil + Prazosin (IU) vs. PlaceboPeterson 1998Physiologic:100%ControlGroup% (n/N)RelativeRisk[95% CI]65.9 (996/1511)**Dosing phase NA –63.9 (159/249)**Dosing phase NA –Range for % response (dose)14.1 (125 mcg) –31.0 (500 mcg)Range for % response(Alprostadil dose/Prazosindose)% Response (dose)3.0 (2000 mcg)–30.4 (125 mcg/500 mcg)–35.7 (500 mcg/2000 mcg)0.4 –Alprostadil (IU) vs. Alprostadil (ICI)Shabsigh2000NR 21.1 (20/95)In-office titration phase,Positive buckling test61.8 (42/68)At-home phase,≥ 1 erection sufficient forintercourse61.1 (58/95)In-office titration phase,Positive buckling test92.6 (63/68)At-home phase,≥ 1 erection sufficient forintercourse0.34[0.23–0.53]0.67[0.55–0.81]154
Physiologic:60.0 (18/30) 90.0 (27/30) 0.67Shokeir 1999 100%[0.49–0.91]Alprostadil (starting dose 250 µg) vs. Alprostadil (starting dose 500 µg)Ekman 2000NRVascular: 43%–47%Diabetes: 21%Psychogenic:7%–12%Prazosin (IU) vs. PlaceboPeterson 1998Physiologic:100%73.5 (122/166) –% Response (dose)% Response3.0 (2000 mcg)0.4 –* Defined as full erection or “positive response,” Grade 4/5 erections, erections sufficient for intercourse, or Rigiscanassessment ≥ 70% rigidity base or tip lasting ≥ 10 minutes** Patients achieving an adequate erectile response were then randomized in the double blind placebo controlled homephaseTable 19: Intra-urethral Treatment: Patients with Adverse EventsStudy Adverse EventTreatmentGroup% (n/N)ControlGroup% (n/N)Alprostadil vs. PlaceboAbsolute RiskDifference[95% CI]Padma-Nathan 1997Penile pain 32.8 (159/485) 3.3 (17/511) 29.0 [25.0–34.0]Williams 1998 Penile pain 5.0 (4/78) 1.2 (1/81) 4.0 [-2.0, 9.0]Padma- Minor urethral trauma 5.2 (25/485) <1.0 (5/511) 4.0 [2.0–6.0]Nathan 1997Williams 1998 Minor urethral trauma 1.3 (1/78) 1.2 (1/81) 0.0 [-2.0, 7.0]Padma- Dizziness 1.9 (9/485) <1.0 (1/511) 2.0 [0.0–3.0]Nathan 1997Williams 1998 Dizziness 2.6 (2/78) 0 (0/81) –Padma- Prolonged erection 0 0 –Nathan 1997Williams 1998 Prolonged erection 1.3 (1/78) 0 –Williams 1998 Urogenital pain/burning 6.4 (5/78) 0 –Padma-Nathan 1997Other events:Priapism or fibrosis00–Williams 1998Urinary tract infectionTesticular pain<1 (1/485)2.6 (2/78)<1 (3/511)0––Priapism or fibrosis00–Urinary tract infection00–Alprostadil vs. Prazosin (IU)155
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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
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 and 174: StudyAdverse EventsTreatmentGroup%
Page 175 and 176: StudyAdverse EventsTreatment Contro
Page 177 and 178: Study / Typeof PatientsOutcome Defi
Page 179: Study ED Etiology OutcomeWilliams*1
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
Page 211 and 212: StudyStudyDesignPatientsage range 4
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
Page 223 and 224: Figure 37. Visual disturbances (all
Page 225 and 226: Figure 43. IIEF-EF ≥ 26 at follow
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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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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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Musacchio Najah S, Hartrich Molly,
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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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