Home  |  Archive  |  AJA @ Nature  |  Online Submission  |  News & Events  |  Subscribe  |  APFA  |  Society  |  Links  |  Contact Us  |  中文版

Erectile dysfunction: on the efficacy of a phosphodiesteraseinhibitor with concurrent sex therapy

Harvey A. Rosenstock, Samuel D. Axelrad1

University of Texas Medical School, Houston, Texas, USA
1Urology Baylor College of Medicine, Houston, Texas, USA

Asian J Androl  1999 Dec; 1: 207-210

Keywords: sildenafil; impotence; phosphodiesterase inhibitors; collaborative models

1 Introduction

Erectile dysfunction (ED) is a condition that affects perhaps 25 to 30 million men in the U.S.A. constituting one of the most significant concerns of sex therapists from various disciplines. Depending on age, 10 to 52 percent of all men can be expected to experience at least temporary ED during their lifetime.

Treatment for ED has traditionally included the following modalities:
(1) Individual Therapy; 
(2) Conjoint Therapy; 
(3) Cognitive Therapy; 
(4) Sensate Focus; 
(5) Sexual Exercises such as the Squeeze Technique of Masters & Johnson; 
(6) Group Therapy; 
(7) There is also a Collaborative Model with a urologist and a psychiatrist[1].

The Collaborative Model begins with a urological examination which may include duplex ultrasonography and nocturnal penile tumescence (NPT) studies. The etiology of the erectile dysfunction can thereby be established to be primarily psychogenic. The results of this phase of evaluation are explained to both the patient and his significant other.

The Collaborative Model also involves a psychiatric consultation with a psychiatrist experienced in sex therapy. After a comprehensive psychosexual history, including a review of the treatments employed to date; a psy chiatric diagnosis is made. The meaning of this diagnosis is explained to both the patient and his partner at which time a treatment plan is developed. A key premise in this Model is that an erection is guaranteed initially even if it has to be produced by mechanical or other medical means such as via cavernosal injections[2-21].

The purpose of this study is to clinically determine the efficacy of a new medication for the treatment of ED a phosphodiesterase inhibitor within the framework of the Collaborative Model.

2 Materials and methods

2.1 Methods

An initial pilot study of 15 men consecutively presenting with ED in a psychiatric office were treated with Viagra (sildenafil citrate), an oral medication. All men were first determined urologically capable of achieving and maintaining an erection as determined by an NPT or duplex ultrasonography and/or clinical history. All men were assessed by the consulting psychiatrist who with the patient and his partner when possible designed a treatment plan, subject to ongoing modifications. All men and their partners were invited to participate in ongoing brief sex therapy sessions which were designed to analyze the sexual relationship and the way intimacy general was mutually expressed.

Those patients with a normal NPT or a normal duplex ultrasonography or with a clinical history that supported a psychogenic etiology for the ED, were given a trial on Viagra with the intention to produce an erection sufficient for penetration. The patients understood that should they fail to obtain a satisfactory erection with Viagra, they would be referred for cavernosal injections with papaverine, prostaglandin, or Trimix, a combination of the preceding drugs plus phentolamine, a non-selective adrenergic antagonist. Thus, an erection was guaranteed for these patients as part of the first phase of treatment.

2.2 Phosphodiesterase inhibitors

An enzyme found in the penisphosphodiesterase type 5led researchers to investigate a medication that could be taken orally and enhance the likelihood that an erection could be achieved through normal physiologic means under conditions of sexually stimulating intimacy. Viagra is the first such clinically available phosphodiesterase inhibitor in the United States.

2.3 Demographics

Fifteen men, ages 27 to 72 with a mean of 64.8 years, were identified as candidates for the study. All were Caucasian with at least 12 years of education. All were determined to be suffering from ED. All had attempted to resolve ED previously by traditional means but without success. Eight patients were receiving antidepressant medications (bupropion, venlafaxine, mirtazepine, or selective serotonin reuptake inhibitors).

Five of the 15 patients (33.3 %) suffered from hypertension, benign prostatic hypertrophy, cancer of the prostate, and/or non-insulin dependent diabetes mellitus. It was felt that these disorders contributed to the ED; ten patients (66.7 %) had no identified organic factors that contributed to the etiology of ED.

2.4 Duration of treatment

The patients were seen for an average of 3.7 therapy sessions over a three month period. The number of sessions actually ranged from two to eight sessions.

2.5 Viagra administration

All men were initially prescribed one 50 mg tablet of Viagra orally two hours before anticipated sexual activity. This dosage was adjusted in accordance with the clinical response. By the end of three months, ten patients were taking 50 mg and five were taking 100 mg of Viagra two hours before anticipated sexual activity.

Patients were asked to rate their own satisfaction outcome on a five tiered subjective scale after that developed by Dr. Tom Lue[2,14]:
S-5: Almost always or always satisfied 
S-4: Satisfied most of the time 
S-3: Generally satisfied 
S-2: Satisfied some of the time
S1: Almost never or never satisfied

The patients were also asked to grade the quality of the erections achieved on a four tiered scale after the model of M. Boolell, et al[3,4]:
G-4: Fully rigid penis sufficient for penetration
G-3: Increased hardness sufficient for penetration but not fully rigid 
G-2: Increase in size with slight hardness but insufficient for penetration 
G-1: Increase in size but no hardness

3 Results

The satisfaction ratings after a three month trial with concurrent brief sex therapy sessions lasting 25-35 min each, were as follows: 
S-5: 13 patients (86.7%) 
S-4: 2 patients (13.3%) 
S-3: 0 patients (0%) 
S-2: 0 patients (0%) 
S-1: 0 patients (0%)

The patients' self-assessment of the quality of the erections after a three month period with concurrent brief sex therapy sessions lasting 25-35 min each were as follows:  
G-4: 13 patients (86.7%) 
G-3: 2 patients (13.3%) 
G-2: 0 patients (0%) 
G-1: 0 patients (0%).

The fact that all of the patients graded their satisfaction levels as being satisfied almost always or always suggests that the combined treatment of brief sex therapy sessions with Viagra produces essentially complete satisfaction. Similarly, with all of the patients indicating that the erection they obtained was either fully rigid and sufficient for penetration or not fully rigid but still sufficient for penetration is indicative of the success of sex therapy combined with Viagra in selected patients. The results suggest that there is a positive impact from even brief sex therapy sessions. It would be of clinical interest to have a group of patients assessed by the authors, a psychiatrist/Certified Sex Therapist, and a urologist with Viagra being prescribed but without concurrent brief sex therapy sessions. The hypothesis is that the degree of satisfaction and that the quality of the erections would be comparatively less.

Although partners were invited to participate in the sex therapy sessions, none chose to do so formally. Nevertheless, some partners sent back positive comments with the partner receiving the Viagra and concurrent sex therapy. The comments from the spouses urged the continuing use of Viagra. One partner in fact sent her best regards to the prescribing physician as symbolic of her satisfaction with the treatment regimen. One patient chose not to tell his spouse that he was receiving sex therapy and being prescribed Viagra; he rather enjoyed the positive comments from his wife without wanting to take the risk of diminishing her complete satisfaction with their sexual experiences.

Comments from patients taking Viagra were typified by the following: 
(1) Increased confidence, 
(2) Cured, 
(3) Dynamite! 
(4) Improved quality of life; 
(5) More intense orgasm; 
(6) Multiple orgasms the same night; 
(7) Natural! 
(8) The first time I have been able to perform in five years!
(9) After years we are going to have to discuss birth control!
(10)Extreme satisfaction

Of interest was the fact that three patients reported the Viagra effect on the day following the taking of Viagra, suggesting that Viagra was effective for 24 hours.

Phosphodiesterase inhibitors offering new, safe alternatives for the treatment of ED may very well be the first line treatment of choice in the production of erection where there is a temporary psychogenic etiology. This is also the case when ED is secondary to organic factors such as vascular insufficiency and diabetes mellitus or when the etiologies are mixed with both organic and psychogenic factors being extant. In all instances, an adequate medical assessment is presupposed with the Collaborative Model being one suggested approach[1].

4 Discussion and summary

Limitations of this study include the small cohort, the lack of a double blind protocol, and the absence of long term experience and followup. That all patients received ongoing brief sex therapy is seen as a facilitative factor. Further studies assessing the success of Viagra without concurrent sex therapy, but under circumstances similar to this study, would likely be informative and are encouraged.

The safety of long term Viagra usage has not been determined beyond two years. How long couples can maintain their gains once Viagra has been discontinued has also yet to be more thoroughly researched.

Finally, one of the most important factors for the clinical success with Viagra is in the judgment of the authors the fact that erections are achieved only as a result of partner-partner intimacy. The problem with erections produced by mechanical means which can occur in the absence of the partner is obviated by the use of Viagra. All patients are informed that taking Viagra alone without sexual stimulation will not produce an erection. The patients and their partners are very complimentary about this requisite. This has especially been the case for patients who have previously attempted to treat ED with vacuum devices, intraurethral inserts of prostaglandin, and intracavernosal injections. Thus, the necessity for partner involvement in the production of the erection makes the describing of Viagra even more positively unique. The authors caution that it is important that all patients be medically assessed before prescribing Viagra as part of the treatment for ED. The prescribing of antidepressants whether bupropion, venlafaxine, mirtazepine, or selective serotonin reuptake inhibitors did not in any way adversely impact the effects of Viagra in any of these patients. The selection of appropriate candidates for Viagra can only enhance the therapeutic results and simultaneously protect the patient from the perils and sequelae of an incorrect diagnosis.

References

[1] Rosenstock H, Axelrad S. Involving his partner: a Collaborative Model for treating refractory erectile dysfunction. Medical Aspects of Human Sexuality 1998; 1(2): 7-11.
[2] Lue T, Iriye A. Medical management of erectile dysfunction. In Walsh P, et al, editors. Campbell's urology update; v 22. Philadelphia: WB Saunders Co; 1997. p 1-9.
[3] Boolell M, Allen MJ, Ballard RA, Gepi-Attee S, Muirhead GJ, Naylor AM. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Int J Impot Res 1996; 8: 47-52.
[4] Boolell M, Gepi-Attee S, Gingell JC, Allen MJ. Sildenafil, a novel effective oral therapy for male erectile dysfunction. Br J Urol 1966; 78: 257-61.
[5] Schiavi R, Rehman J. Sexuality and aging. Urol Clin North Am 1995; 22: 711-26.
[6] McConnell J, Wilson J. Alterations in reproductive and sexual functionimpotence. In: Harrison TR, editor. Principles of internal medicine. 12th ed. New York: McGraw-Hill; 1991. p 296-8.
[7] Kaplan H. The New Sex Therapy. New York: Brunner-Mazel; 1974. p 255.
[8] Levine S, Althof S. The pathogenesis of psychogenic erectile dysfunction. J Sex Educ Ther 1991; 17: 251-66.
[9] Rosenstock H. Functional impotence. Clinical typology and group therapy technique for the monogamous male. J Houston Group Psychother Soc 1987; 2: 6777.
[10] Rosenstock H. Medical considerations for successful sex therapy. SIECUS J 1995; 23 (5): 11-2.
[11] Tiefer L, Schuetz-Mueller D. Psychological issues in diagnosis and treatment of erective disorders. Urol Clin North Am 1995; 22: 767-73.
[12] Baum N, Rhodes D. A practical approach to the evaluation and treatment of erectile dysfunction. Urol Clin North Am 1995; 22: 865-77.
[13] Christ G. The penis as a vascular organ. Urol Clin North Am 1995; 22: 727-45.
[14] Aboseif S, Lue T. Hemodynamics of penile erection. Urol Clin North Am 1988; 15: 17.
[15] Levine L, Lenting E. Use of nocturnal penile tumescence and rigidity in the evaluation of male erectile dysfunction. Urol Clin North Am 1995; 22: 775-88.
[16] Mulhall J. Evaluation and treatment of sexual dysfunction. Psychiatric Update 1997; 17 (3): 4.
[17] Meuleman E, Diemont W. Investigation of erectile dysfunction. Urol Clin North Am 1995; 22: 803-19.
[18] Benet A, Melman A. The epidemiology of erectile dysfunction. Urol Clin North Am 1995; 22: 803-19.
[19] Jeremy JV, Ballard SA, Maylor AM, Miller MA, Angelini GD. Effects of sildenafil, a type 5 GMP phosphodiesterase inhibitor, and papaverine on cyclic GMP and cyclic AMP levels in the rabbit corpus cavernosum in vitro. Br J Urol 1997; 79: 958-63.
[20] Eardley J, Morgan RJ, Dinsmore WW, Pearson J, Wolff MB, Boolell M. UK-92,480, a new oral therapy for erectile dysfunction, a double-blind, placebo controlled trial with treatment taken as required. Proceedings of the 91st annual meeting of the American Urological Association; 1996 May 4-9; Orlando, Florida. Abstract 737.
[21] Gingell CK, Jardin A, Olston AM, et al. UK-92,480, a new oral treatment for erectile dysfunction: a double-blind placebo-controlled, once daily dose response study. Proceedings of the 91st annual meeting of the American Urological Association; 1996 May 4-9; Orlando, Florida. Abstract 738.
home

Correspondence to Harvey A. Rosenstock, M.D., F.A.C.P., Clinical Associate Professor of Psychiatry and Behavioral Sciences.
Tel: +1-713-666 3600   Fax: +1-713-666 0987
e-mail: hrosenstoc@aol.com
Received 1999-09-17     Accepted 1999-10-20