Clinical InvestigatIon - Europe PMC

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To determine the efficacy of the intracavernous administration of papaverine hydrochloride every 2 weeks to treat male impotence, we recruited 50 patients from ...
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Clinical InvestigatIon Biweekly Intracavernous Administration of Papaverine for Erectile Dysfunction ARSHAG D. MOORADIAN, MD, Tucson; JOHN E. MORLEY, MD; FRAN E. KAISER, MD; SUSAN S. DAVIS, MD; SHARON P VIOSCA, MS; and STANLEY C. KORENMAN, MD, Sepulveda, California

To determine the efficacy of the intracavernous administration of papaverine hydrochloride every 2 weeks to treat male impotence, we recruited 50 patients from a sexual dysfunction clinic. Of these, 8 did not complete the course of papaverine therapy. A total of 8 had complications, including priapism in 3 and ecchymoses or urethral bleeding in 5. In 30 patients who had substantial vasculogenic disease, there was a notable improvement in the penile blood pressure after papaverine treatment, although only 9 reported successful sexual intercourse. The penile blood pressure in the remaining 12 patients without substantial vascular disease increased modestly after therapy, and 5 persons reported satisfactory sexual activity. We conclude that administering papaverine intracavernosally every 2 weeks improves sexual potency in a subset of sexually impotent patients. Those with severe vasculogenic disease and a penile-brachial pressure index of less than 0.65 are not good candidates for this regimen. (Mooradian AD, Morley JE, Kaiser FE, et al: Biweekly intracavernous administration of papaverine for erectile dysfunction. West J Med 1989 Nov; 151 :515-517)

Although psychological factors often complicate sexual dysfunction in men older than 40 years, the underlying primary cause is usually organic. 1-4 The predominant organic cause of impotence is vascular disease. The primary defect in vasculogenic impotence is impaired maximal penile blood flow, although the ultimate common denominator of erectile dysfunction of various causes is a failure of the accumulation of blood in the corpora cavernosa, hence, the rationale of using vasodilating agents such as papaverine hydrochloride and phentolamine hydrochloride in treating vasculogenic impotence.5-7 It has been suggested that patients with vasculogenic impotence who respond to papaverine should be offered training in self-injection.7'8 The long-term effects, however, of intracavernous injections remain unknown, and possible scarring of the spongy tissue is of concern. It is thus of interest to determine the efficacy of alternate protocols of papaverine therapy given for a short period of time. We elected to determine whether the biweekly (once every two weeks) intracavernous administration of papaverine for a total of eight weeks would result in a persistent improvement of sexual potency in a subset of patients. It has been suggested that this regimen is an acceptable alternative to the autoinjection protocols.9 We also tried to ascertain whether the clinical response-improved sexual potency-correlates with the improvement in penile blood flow.

Patients and Methods A total of 50 patients were recruited from the sexual dysfunction clinic at the Sepulveda (California) Veterans Ad-

ministration Medical Center. The mean age was 59.2 + 1.6 years, with a range of 40 to 70 years. Patients were excluded who did not have a sexual partner or who had strong psychogenic diseases or androgen deficiency without testosterone replacement. All subjects signed a consent form approved by the hospital's Human Subjects Study Committee. None of the patients had been previously treated for sexual dysfunction, except for four hypogonadal patients who were on testosterone replacement therapy. The sex partners of all patients were also interviewed. The mean duration of impotence (inability to have intercourse) was 4.25 + 0.79 years (range 5 months to 16 years). Before the onset of sexual dysfunction, all patients had been engaged in healthy sexual activity. Eight did not complete the course of therapy either because of a complication or a lack of motivation. Of the 42 patients who completed therapy, 13 had diabetes mellitus, 8 were receiving treatment for hypertension, and 8 had stable coronary artery disease. Other medical problems included chronic Qbstructive lung disease in 4 patients, alcoholic neuropathy in 1, alcoholic cirrhosis in 1, and arthritis in 2. Five had no major medical problems. All except six of the patients were smokers with a history of more than ten pack-years. The penile blood pressure was measured by Doppler ultrasound. We found the coefficient of variation of penile blood pressure measurements within the same person to be 3.1 %. Patients were considered to have significant vasculogenic disease if the ratio of penile systolic pressure to brachial artery systolic pressure (penile-brachial pressure index) was less than 0.75 with the patient resting, standing, or exercising. The cause of the sexual dysfunction in the

From the Geriatric Research, Education and Clinical Center (Drs Mooradian, Morley, and Kaiser), Department of Medicine (Dr Mooradian, Dr Morley, Dr Kaiser, Dr Davis, Ms Viosca, and Dr Korenman), Veterans Administration Medical Center, Sepulveda, California, and the Department of Medicine (Drs Mooradian, Morley, Kaiser, and Korenman), University of California, Los Angeles, School of Medicine. Dr Mooradian is currently with the Division of Restorative Medicine, University of Arizona Health Sciences Center, Tucson. Reprint requests to Arshag D. Mooradian, MD, Division of Restorative Medicine, University of Arizona Health Sciences Center, 1821 E Elm St, Tucson, AZ 85719.

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PAPAVERINE IN ERECTILE DYSFUNCTION

TABLE 1.-Ratios of Penile Systolic Blood Pressure to Brachial Systolic Blood Pressure (Mean ± SEM) in Right and Left Dorsal Penile Arteries Before and After a Course of 4 Papaverine Hydrochloride Injections* Penile-Brachial Pressure Indexes

Beferel Patients

With vasculogenic impotence, n=30

Injections .

Without vasculogenic impotence, n=12

....

After Before After Before

Lying Right

Standing Left

0.79±0.02t 0.78±0.02t

0.70±0.02 0.88±0.05 0.84±0.05

0.68±0.03 0.93±0.04 0.92±0.04

Right

Exercising Left

0.79±0.03t 0.77±0.03t 0.65±0.04 0.88±0.03t 0.92±0.01f

0.65±0.04

0.83±0.04

0.88±0.02

Right

Left

0.72±O.03t 0.69±0.03t 0.58±0.02 0.82±0.04 0.80±0.04

0.57±0.03

0.86±0.04t 0.80±0.04

*There was no significant difference between the mean brachial systolic pressure measured before and after papaverine injections. tSignificant difference compared with measurements taken before papaverine given, P