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Table 29: Penile Fibrosis in Studies of Intracavernosal Injection (Non-randomized)StudyPerimenis2006StudyDesignClinical trialPatients38 Greek menMean age 56.4(range 42–62) yearsWith diabetesmellitus (DM) (type Iand II)Althof 1991 Clinical trial 42 American men,mean age 54.4 yearsCanale 1996 Clinical trial 68 Italian men, meanage 50.5 (22-70)yearsPorst 1998 Clinical trial 162 European men,mean age 54 (22-70)yearsClaro 2001Retrospectivecohort168 Brazilian men,median age 61 (43–78) years, hadundergoneprostatectomy forlocalized prostatecancerLepore 2001 Clinical trial 52 Italian men,mean age 56.7(range 35–74) yearsWith diabetesPerimenis2001Wespes2000Shmueli1999Clinical trialClinical trialClinical trial40 Greek men18 diabetic and 22non–diabetic controlsMean age 55.6 (48–64)10 Belgian men,mean age 56.5 (46–69) years452 Israeli men,mean age 59.5 (26–85) yearsTreatment(s)1. Prostaglandin(PGE 1 ) 5–20 µg2. Papaverine(PAP) ≥8 mg3. PGE 1 + PAP20 µg/ 8 mgPAP +phentolamine,NRPGE 1, 20 µg/ml/wk (20-60 µg/2-3d in one case)TreatmentDurationFibrosis %(n/N)byTreatmentGroup10 years 13.2%(5/38)12 months 26%> 12months4.4% (3/68)PGE 1 , NR 1- 4 y 11.7%(19/162)1 st y: 6.8%2 nd y: 2.5%3 rd y: 7.3%4 th y: 1.7%1. PAP +Phentolamine NR 0%(PHEN) + PGE 122.6 mg / 1.34mg/ 13.4 mg1. PGE 1 NR2. Sildenafil1. PGE 1 5–20 µg2. PAP 8–16 mg3. PGE 1 + PAP20 µg/ 8–16 mg3 months7 years0%17.5%(7/40)One nondiabeticcontroldevelopedearlyPeyronie’splaqueleading tostudywithdrawal1. PGE 1 6–20 ug NR 0%Protocol I: PAP +PHEN 6–25 mg/0.05–1.5 mg.6 months0%Smallnodules179
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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
Page 177 and 178: Study / Typeof PatientsOutcome Defi
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
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Page 212 and 213: Figures Note: Figure 1 (Analytic Fr
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Page 218 and 219: Figure 1. The mean IIEF-Q3 score: m
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Page 224 and 225: Figure 40. Successful intercourse a
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Page 228 and 229: Figure 52. The mean IIEF “EF doma
Page 230 and 231: Figure 58. Flushing (all cause)Figu
Page 232 and 233: Figure 64. Mean per-patient percent
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Page 236 and 237: References and Included Studies 1.
Page 238 and 239: 52. Deeks JJ, Higgins JP, Altman DG
Page 240 and 241: treatment withdrawal. Int J Impot R
Page 242 and 243: 133. Olsson AM, Persson CA, Swedish
Page 244 and 245: May-Jun;27(3):480]. J Androl 2006Ma
Page 246 and 247: 209. Hellstrom WJ, Elhilali M, Home
Page 248 and 249: study in 14 European countries. J S
Page 250 and 251: prostaglandin E1. J Urol 1992 Oct;1
Page 252 and 253: 327.and mood in men with erectile d
Page 254 and 255: 371. Shmueli J, Israilov S, Segenre
Page 256 and 257: List of Acronyms/AbbreviationsCLINI
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IU/Lkgkg/m2mmgmg/dmLmmol/LNng/dLng/
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Appendix A. Search StrategiesMedlin
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22. erecti$.tw.23. 21 or 2224. CLIN
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14. 3 and 1315. limit 14 to yr="199
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1. exp Sleep Apnea Syndromes/2. Opt
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Appendix B. Data Assessment, Data A
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Cross-national ecological analysisO
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Randomized Controlled Trials (Jadad
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Appendix C. Evidence TablesC1-Oral
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AuthorFundingN; study design; eligi
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C-11 AuthorFundingN; study design;
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C-83 C2-Oral Vardenafil AuthorFundi
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C-105 C3-Oral Tadalafil AuthorFundi
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C-135 F4-Apomorphine (sublingual) A
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C-191 C6-Subcutaneous Treatment Tri
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C-195 C7- Intra-urethral Suppositor
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C-237 C10-Off Label Treatments Auth
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References(1) Abdel-Naser MB, Imam
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in Colombia, Ecuador, and Venezuela
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(67) Rendell MS, Rajfer J, Wicker P
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(100) Martin-Morales A, Meijide F,
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controlled study. Urology 2006; 68(
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(166) el-Saleh JC, Keogh EJ, Chew K
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(201) Wessells H, Levine N, Hadley
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with hypogonadal symptoms. Arch Gen
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Appendix D. Reference List of Exclu
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Akduman B, Crawford E D. The PCPT:
Page 807 and 808:
Anderson R U, Wise D, Sawyer T et a
Page 809 and 810:
Atala A, Amin M. Current concepts i
Page 811 and 812:
Barbaree H E, Mewhort D J. The effe
Page 813 and 814:
Bereczky Z, Bolus M, Chetty P et al
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Blaya C, Seganfredo A C, Dornelles
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Brioni J D, Moreland R B, Cowart M
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Campbell S F. Science, art and drug
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Champion H C. Erectile dysfunction
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Chung W S, Choi H K. Erotic erectio
Page 825 and 826:
Crasilneck Harold B. Hypnotic techn
Page 827 and 828:
De Leval J, Boca P, Youssef E et al
Page 829 and 830:
Doggrell S A. Combination of finast
Page 831 and 832:
Eardley I. Optimisation of PDE5 Inh
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Evans M F. Critical appraisal: Lose
Page 835 and 836:
Formenti S C, Lieskovsky G, Simonea
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Garcia-Campayo Javier, Sanz-Carrill
Page 839 and 840:
Gleave M, Qian J, Andreou C et al.
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Carson C C. Erectile dysfunction: E
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Glina S. Testosterone and erectile
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Kalsi J S, Bahadur G, Muneer A et 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
Page 853 and 854:
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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Anonymous. Sildenafil appears safe
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Bella A J, Brock G B. Tadalafil: A
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Carson C C, Burnett A L, Levine L A
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Curran M, Keating G. Tadalafil.[err
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Fagan T C, Buttler S, Marbury T et
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Greenstein A, Plymate S R, Katz P G
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Hunter R H, Joy C B, Kennedy E et a
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Kloner R A, Mitchell M, Emmick J T.
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Long R L, Sherman L S, Lombardi T J
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Miller N, Smolkin M E, Bissonette E
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Nurnberg H, George. Erectile Dysfun
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Porst H, Giuliano F, Glina S et al.
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Salonia Andrea, Briganti Alberto, M
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Solursh Lionel P, Solursh Diane S.
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van Basten J P, Van Driel M F, Hoek
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Yasumoto R, Nishisaka N, Sakakura T
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Chen J, Godschalk M F, Katz P G et
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Hellstrom W J. Vardenafil: a new ap
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Webb D J, Muirhead G J, Wulff M et
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Kim J M, Joh Y D, Huh J D et al. Do
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Tariq S H, Haleem U, Omran M L et a
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Aizenberg Dov, Gur Shay, Zemishlany
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Beretta G, Marzotto M, Zanollo A et
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Cheng E. Real-life safety and effic
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English J C, King D H C, Foley J P.
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Goldstein I, Auerbach S, Padma-Nath
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Jackson G. Sildenafil (Viagra): New
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Lane B Z, Ausmundson S J, Butler R
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McMahon C G. An attempt to standard
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Mulhall J P, Land S, Parker M et al
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Pohanka M, Kanovsky P, Bares M et a
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Ruof J, Graf-Morgenstern M, Mnller
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Sparwasser C, Treiber U, Bahren W e
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Wagner G, Montorsi F, Auerbach S et
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Anderson R A, Martin C W, Kung A W
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Baggaley M R, Hirst J F, Watson J P
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Buvat J, Boujadoue G. Testosterone
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Contreras L N, Masini A M, Danna M
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Engelhardt P F, Daha L K, Zils T et
Page 937 and 938:
Glasser S P. Safety of PDE 5 inhibi
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Holtkamp M, Weissinger F, Meierkord
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Kirby R S. Report from London. Pros
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Lexchin J. New drugs with novel the
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Mealy N E. Avanafil. Drugs of the F
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Nakata M, Takashima S, Kaminou T et
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Phillips B G, Kato M, Pesek C A et
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Saad F, Grahl A S, Aversa A et al.
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Sipski M, Alexander C, Guo X et al.
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Traish A M, Goldstein I, Kim N N. T
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Wilt T J, Fink H A. Is antidepressa
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Price D E, Cooksey G, Jehu D et al.
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Bolona E R, Uraga M V, Haddad R M e
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Anonymous. Sublingual apomorphine:
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Bouloux P. Testim 1% testosterone g
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Christ B, Brockmeier D, Hauck E W e
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Fein R L. Classification of sexual
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Green B G, Martin S. Clinical asses
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John H, Lehmann K, Hauri D. Intraur
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Lee W R. The role of androgen depri
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Mealy N E. Alprostadil cream. Drugs
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Murphy J C, Srinivas S, Terris M K.
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Pommerville P. Drug treatments for
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Saie D J, Sills E S. Hyperprolactin
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Steidle C P, McCullough A R, Kamine
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Weiss J N, Badlani G H, Ravalli R e
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Anonymous. Study shows patients tak
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Bartlik Barbara D, Kaplan Peter, Ka
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Cawello W, Schweer H, Dietrich B et
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Del Popolo G, Li Marzi V, Mondaini
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Gallo L, Perdona S, Autorino R et a
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Hofner K, Claes H, De Reijke T M et
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Kloner R A, Hutter A M, Emmick J T
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Maan Z, Arya M, Shergill I et al. P
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Montorsi F, Strambi L F, Guazzoni G
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Phelps J S, Jain A, Monga M. The Ps
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Sato Y, Suzuki N, Adachi H et al. E
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Strachan M W, Teoh W L, Don-Wauchop
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Weinhardt L S, Carey M P. Prevalenc
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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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