Key Clinical Trials in Erectile Dysfunction

by Carson, Culley C.

• ISBN13: 9781846284274
• ISBN10: 1846284279
• eBook ISBN(s): 9781846284281
• Edition: 1st
• Format: Paperback
• Copyright: 2006-12-15
• Publisher: Springer Verlag
• More Book Details
• Purchase Benefits

Summary

This book represents a critical appraisal of the major clinical trials that have had a significant impact on clinical research and practice during the last decade. Each trial follows a strict format, starting with reference to the original source of publication, details on the key investigators and their methods of research. The strengths and weaknesses of each trial are discussed as well as their influence on clinical practice. Articles are complemented by a diagrammatic summary of the trial design and the key findings. It is estimated that over 20 million men in Europe alone suffer at some time in their life from erectile dysfunction (ED). This is the first book to bring together in a single volume a critical review of all the major trials in ED.

Table of Contents

1. The Earliest Carefully Controlled Clinical Trial Evaluating Oral Pharmacotherapy (Yohimbine) in ED	1
1.1 Key Trial References	1
1.2 Importance of Study	1
1.3 Study Design	1
1.4 Key Results	2
1.5 Conclusions from Original Reports	3
1.6 Strengths	3
1.7 Weaknesses	3
1.8 Relevance	3
2. A Description of the Pioneering Work That Led to the First Approved Agents for ED: Giles Brindley, the Needle, and the Penis (Phenoxybenzamine)	4
2.1 Key Trial References	4
2.2 Importance of Study	4
2.3 Study Design	4
2.4 Key Results	5
2.5 Conclusions from Original Reports	6
2.6 Strengths	6
2.7 Weaknesses	6
2.8 Relevance	7
3. The Pivotal Study Showing That Intracorporal Injection of Vasoactive Agents (Papaverine or Phenoxybenzamine) Was Effective Pharmacotherapy	8
3.1 Key Trial References	8
3.2 Importance of Study	8
3.3 Study Design	8
3.4 Key Results	9
3.5 Conclusions from Original Reports	10
3.6 Strengths	11
3.7 Weaknesses	11
3.8 Relevance	11
4. The First Placebo-Controlled Study on the Benefits of Intracorporal Administration of Vasorelaxant Agents to ED Patients (Papaverine/Phentolamine Combination)	12
4.1 Key Trial References	12
4.2 Importance of Study	12
4.3 Study Design	13
4.4 Key Results	14
4.5 Conclusions from Original Reports	15
4.6 Strengths	15
4.7 Weaknesses	15
4.8 Relevance	15
5. Representative Study on the Use of Yohimbine in the Treatment of Organic ED	16
5.1 Key Trial References	16
5.2 Importance of Study	16
5.3 Study Design	16
5.4 Key Results	18
5.5 Conclusions from Original Reports	19
5.6 Strengths	19
5.7 Weaknesses	19
5.8 Relevance	19
6. Defining the Therapeutic Ratio for Intracavernosal Administration of Prostaglandin E1 (Alprostadil)	20
6.1 Key Trial References	20
6.2 Study Funding	20
6.3 Importance of Study	20
6.4 Study Design	20
6.5 Key Results	22
6.6 Conclusions from Original Reports	23
6.7 Strengths	23
6.8 Weaknesses	23
6.9 Relevance	23
7. An Elegant Long-Term Trial Assessing the Clinical Profile of Intracavernosal Prostaglandin E1 (Alprostadil)	24
7.1 Key Trial References	24
7.2 Importance of Study	24
7.3 Study Design	24
7.4 Key Results	25
7.5 Conclusions from Original Reports	27
7.6 Strengths	27
7.7 Weaknesses	27
7.8 Relevance	27
8. Evaluation of Novel Combination (Vasoactive Intestinal Polypeptide and Phentolamine) as Intracavernosal Therapy	28
8.1 Key Trial References	28
8.2 Study Funding	28
8.3 Importance of Study	28
8.4 Study Design	29
8.5 Key Results	30
8.6 Conclusions from Original Reports	31
8.7 Strengths	31
8.8 Weaknesses	32
8.9 Relevance	32
9. Now-Classic Study on the Use of Intraurethral Prostaglandin E1 (Alprostadil)	33
9.1 Key Trial References	33
9.2 Study Funding	33
9.3 Importance of Study	33
9.4 Study Design	33
9.5 Key Results	35
9.6 Conclusions from Original Reports	36
9.7 Strengths	36
9.8 Weaknesses	36
9.9 Relevance	36
10. Route of Administration Has a Considerable Impact on Clinical Profile: A Comparison of Intraurethral and Intracavernosal Alprostadil	37
10.1 Key Trial References	37
10.2 Importance of Study	37
10.3 Study Design	37
10.4 Key Results	38
10.5 Conclusions from Original Reports	39
10.6 Strengths	40
10.7 Weaknesses	40
10.8 Relevance	40
11. First Clinical Data on Sildenafil: The Arrival of Oral Pharmacotherapy	41
11.1 Key Trial References	41
11.2 Study Funding	41
11.3 Importance of Study	41
11.4 Study Design	41
11.5 Key Results	42
11.6 Conclusions from Original Reports	43
11.7 Strengths	43
11.8 Weaknesses	44
11.9 Relevance	44
12. Original "Gold Standard" Clinical Trial of Sildenafil in ED	45
12.1 Key Trial References	45
12.2 Study Funding	45
12.3 Importance of Study	45
12.4 Study Design	45
12.5 Key Results	47
12.6 Conclusions from Original Reports	48
12.7 Strengths	48
12.8 Weaknesses	48
12.9 Relevance	48
13. Pilot Study Showing Benefit of Clinical Response to Apomorphine Sublingual (SL)	49
13.1 Key Trial References	49
13.2 Study Funding	49
13.3 Importance of Study	49
13.4 Study Design	50
13.5 Key Results	51
13.6 Conclusions from Original Reports	52
13.7 Strengths	52
13.8 Weaknesses	52
13.9 Relevance	53
14. A Viable Alternative to PDE Inhibitors: Definition of Therapeutic Ratio of Apomorphine Sublingual (SL) in Patients with ED	54
14.1 Key Trial References	54
14.2 Study Funding	54
14.3 Importance of Study	54
14.4 Study Design	54
14.5 Key Results	56
14.6 Conclusions from Original Reports	57
14.7 Strengths	57
14.8 Weaknesses	57
14.9 Relevance	57
15. Summary of Clinical Trials of Phentolamine	58
15.1 Key Trial References	58
15.2 Importance of Study	58
15.3 Study Design	58
15.4 Key Results	59
15.5 Conclusions from Original Reports	60
15.6 Strengths	60
15.7 Weaknesses	61
15.8 Relevance	61
16. Impact of Testosterone Replacement in Androgen-Deficient Males	62
16.1 Key Trial References	62
16.2 Study Funding	62
16.3 Importance of Study	62
16.4 Study Design	62
16.5 Key Results	63
16.6 Conclusions from Original Reports	65
16.7 Strengths	65
16.8 Weaknesses	65
16.9 Relevance	65
17. Evaluation of Psychotherapy for Patients and Partners	66
17.1 Key Trial References	66
17.2 Importance of Study	66
17.3 Study Design	66
17.4 Key Results	67
17.5 Conclusions from Original Reports	69
17.6 Strengths	69
17.7 Weaknesses	69
17.8 Relevance	69
18. Quantification of Benefit of a Vacuum Device on Erectile Function	70
18.1 Key Trial References	70
18.2 Importance of Study	70
18.3 Study Design	70
18.4 Key Results	71
18.5 Conclusions from Original Reports	73
18.6 Strengths	73
18.7 Weaknesses	73
18.8 Relevance	73
19. Pioneering Clinical Trial of Surgical Procedures	74
19.1 Key Trial References	74
19.2 Importance of Study	74
19.3 Study Design	74
19.4 Key Results	75
19.5 Conclusions from Original Reports	76
19.6 Strengths	76
19.7 Weaknesses	76
19.8 Relevance	76
Index	77