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StudyStudyDesignPatientsTreatment(s)TreatmentDurationFibrosis %(n/N)byTreatmentGroupPatients who Protocol I:failed received 0.6%Protocol II: PGE 1 (3/452)10–25 µg. Protocol II:Patients who 2% (3/147)failed receivedProtocol III:Protocol III: PAP 3.5% (3/86)+ Phentolamine + Protocol IV:PGE1 Patients 9.7% (3/31)who failedreceivedProtocol VI: PAP+ Phentolamine +PGE1+ atropine0.02–0.06 mgChew 1997 Retrospective 245 Australian men, 1. PGE 1 2–60 µg 2.1 years 23.3%cohort mean age 62 (21–79)years, hypertension(22.8%), DM (8.5%)(mean 13 µg) (up to 86months)(57/245)Sundaram Retrospective 160 American men 1. PAP 30 mg 1–5 years <1%1997 cohort Age not reported 2. PAP + PHEN (1 patient)25 mg + 0.83 mg3. PGE 1 NR(alternativetherapy)Gupta 1997Flynn 1996RetrospectivecohortRetrospectivecohort1089 American men,mean age 62 (21–94)years126 British men,mean age 57 (27–77)years, 40% had comorbidities1. PGE 1 5–10 µg2. TRIMIX 4.41mg/ 0.5 mg/ 1.47µg3. PGE 1 + PAP5–10 µg/ 30 mg4. PAP + PHEN30 mg/ 0.5 mg1. PAP NR2. PAP + PHENNRUp to 80monthsPenilescarring/nodules inpatientsdiscontinuing therapy1. PGE 110.7%(8/75)2. TRIMIX23.1%(6/26)3. PAP +PHEN11.1%(4/36)3.9 years <1% (1subject)Chen 1996 Retrospective 92 American men, 1. PGE 1 initial 1–56 16.3%cohort mean age 58.6 (32–78) years, 67% hadco-morbiditiesdose <10 µg/mlin most casesmonths (15/92)Bolayir 1994 Clinical trial 40 Cypriot men, 1. PAP + 1 year 2.5% (1/40)180
StudyStudyDesignPatientsage range 40–75yearsHattat 1994 Clinical trial 69 Turkish men,mean age 52.6 (31–71) yearsBetts 1994 Clinical trial 46 British men,mean age 39 (26–58)with multiple sclerosisChiang 1992 Clinical trial 51Taiwanese men,mean age 58.3 (29–79) yearsTreatment(s)Verapamil 20–35mg/5 mg1. PGE 1 NR2. PAP NRTreatmentDuration13.6monthsFibrosis %(n/N)byTreatmentGroup3.6% (2/56)PAP0 (0/13)PGE 11. PAP 10–80 mg NR 2.2% (1/46)1. PGE 1 5–40 µg2. PAP 15–60 mg1 year 3.9% (2/51)Kerfoot 1991Schramek1990RetrospectivecohortClinical trial119 American menGroup 1 (n = 65):Geriatric (>65), meanage 70 yearsGroup 2 (n = 54):younger, mean age47149 Austrian men,Mean age 56.5 (25–76) years1. PAP + PHEN30 mg / 1.0 mg(titrated up to 1.5if no response)1. PGE1 10–40µg> 6 months 2.5%(3/119)NR 0%181
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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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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
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Page 179 and 180: Study ED Etiology OutcomeWilliams*1
Page 181 and 182: Physiologic:60.0 (18/30) 90.0 (27/3
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
Page 205: 177Table 28: Nonarteritic Anterior
Page 209: Table 29: Penile Fibrosis in Studie
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
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Page 231 and 232: Figure 61. Mean per-patient percent
Page 233 and 234: Figure 67. Any adverse events (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
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Page 251 and 252: moderate and severe ED. Int J Impot
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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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(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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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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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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Sparwasser C, Treiber U, Bahren W e
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Cooper A J. Evaluation of I-C papav
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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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