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Efficiency and side effects of intracavernous injections of moxisylyte in impotent patients: a dose-finding study versus placebo.

We assessed the efficiency and tolerance of the alpha-blocking agent moxisylyte in 2 double-blind studies versus placebo performed in 12 neurogenic patients with spinal cord lesions and in 61 patients presenting with either psychogenic impotence (30) or erectile dysfunction that was predominantly neither psychogenic, hormonal nor neurogenic (31). In each etiological group patients were randomized (according to latin square method) to receive 3 single doses (10, 20 and 30 mg.) of moxisylyte and a placebo. The erectile response was determined 5, 10, 15, 20 and 30 minutes after each injection. Whatever etiology of impotence and dosage tested, the erectile response induced by moxisylyte was significantly higher than the placebo-induced response. No difference occurred among the 3 doses. In 93% of the patients moxisylyte induced an erectile response, including tumescence in 6, partial rigidity in 16 and complete rigidity in 46. Thus, in 62 of 73 patients (85%) the drug allowed initiation of erection adequate for intercourse. Placebo induced such erection in only 25% of the cases and in 55% there was no response. Tolerance was good and no priapism occurred. Only 4 patients (5%) reported mild pain during injection but erections were never painful, 1 presented with moderate and transient hypotension at the 20 mg. dose and a painless prolonged erection was observed in 1 case after the lowest dose. Drugs such as moxisylyte should be given before less well tolerated drugs.

Adult↗

Necrotizing cavernositis secondary to periodontal abscess.

Spontaneous cavernositis is a distinctly uncommon entity. Corporeal infection and abscess formation have been described in association with priapism, cavernosography, intracavernous injection therapy, trauma and penile prostheses. We report a case of acute necrotizing cavernositis in a diabetic patient, which presumably originated with hematogenous seeding from a periodontal abscess. Isolation of typical oral pathogens from corporeal cultures provides bacteriological evidence of a dental source for the corporeal infection.

Abscess↗

Combined cavernous compression device and arteriovenous-cavernous fistula: a chronic canine model.

In 5 dogs studied over a 3-month period, we evaluated the chronic effects of the combination of deep dorsal vein arterialization with implantation of an inflatable venous compression device. The device was placed around the proximal corpora cavernosa, sparing the left dorsal artery. A left-to-right, end-to-side dorsal artery-dorsal vein fistula was fashioned, and the right dorsal vein was anastomosed to the corpus cavernosum as an end-to-side venocorporeal window. From postoperative day 15, the device was activated twice a day for 3 months. Intracavernous pressure (bilateral) and left dorsal artery blood flow were monitored, and the patency of the anastomoses was evaluated by vascular clamping, arteriography, cavernosography and microscopic dissection. The device was well-tolerated, requiring no anesthesia during activation. (A sixth dog developed glanular hyperemia and priapism and was excluded from evaluation). With cuff inflation, the intracavernous pressure was significantly higher on the experimental side (range, 20 to 106 cm. H2O higher; p = 0.028), and arteriography demonstrated contrast flowing in the fistula and window in 3 of 4 dogs in which it was done. Both clamping and microscopic dissection of the specimen showed patency of the anastomoses in all 5 dogs. Histologic examination revealed maintenance of normal cavernous tissue histology.

Anastomosis, Surgical↗

Intracavernous self-injection with vasoactive intestinal polypeptide and phentolamine in the management of erectile failure.

A total of 52 men, median age 55 years (range 28 to 74 years), with erectile failure was treated with vasoactive intestinal polypeptide and phentolamine. Impotence was classified as psychogenic in 3 patients, psychogenic/arteriogenic in 3, arteriogenic in 25, arteriogenic/neurogenic in 4, neurogenic in 5, venous leakage/psychogenic in 2, venous leakage/neurogenic in 1 and following venous leak surgery in 9. The patients were treated with 30 micrograms vasoactive intestinal polypeptide and 0.5 to 2.0 mg. phentolamine. A total of 1,380 self-injections was given and the number of injections per patient varied from 5 to 245. No patient had priapism, corporeal fibrosis or other serious complications. After sexual stimulation all patients obtained erection sufficient for penetration. Following ejaculation rigidity decreased normally. The median duration of treatment was 6 months (range 1 to 22). Nine patients discontinued treatment. One patient with severe arteriosclerosis experienced decreased effectiveness of the drug and received a penile prosthesis. Five patients elected not to perform self-injection any longer, 1 psychogenic impotent patient was cured, and 1 patient discontinued therapy due to palpitation and sweating. One patient died of a myocardial infarction not associated with this therapy.

Adult↗

Pharmacological erection program using prostaglandin E1.

A total of 72 impotent patients entered into a pharmacological erection program using prostaglandin E1. Of the men 35 (49%) used prostaglandin E1 on a regular basis, while 37 (51%) failed to continue in the program beyond the in-office dose titration period. In patients who continue to use prostaglandin E1 the median duration of drug use is 7 months, with a range of 2 to 28 months. There have been no instances of cavernous fibrosis, systemic reaction or chemical priapism (erection present longer than 4 hours) in any patient. Only 8 men (11%) were unable to achieve an adequate erection with prostaglandin E1 injections. The most common adverse effect of prostaglandin E1 was penile pain after injection. The incidence of severe pain leading to drug discontinuation was 17% (12 of 72 patients) while mild to moderate pain occurred in 22% (16 of 72). Over-all, intracavernous prostaglandin E1 injections appear to be a safe, effective treatment for impotence in most men.

Alprostadil↗

Effects of intracavernosal trazodone hydrochloride: animal and human studies.

Trazodone hydrochloride is an oral antidepressant agent which has been associated with the improvement of erections in impotent men and the development of prolonged erections or priapism in potent men. An in vivo study in animal and human subjects was performed to gain experience with the effect of intracavernosal trazodone. In the anesthetized New Zealand White rabbit, intracavernosal trazodone or its major metabolite m-chlorophenylpiperazine (m-CPP) produced full penile erection in 76% and 84% of animals studied respectively with doses ranging from one to 15 mg. On the other hand, intracavernosal administration of five mg. papaverine resulted in a prolonged erection in 90% of animals studied. In 13 selected volunteer patients, intracavernosal trazodone caused tumescence but not full penile erection with corporal body pressures of 28.2 +/- 5.8 mm. Hg. Intracavernosal papaverine or papaverine and phentolamine in these subjects resulted in significantly higher corporal body pressures of 58 +/- 18 mm. Hg (p less than .05). Intracavernosal administration of alpha adrenoceptor agonists but not normal saline resulted in complete detumescence of trazodone- or m-CPP-induced prolonged erection in the animal studies. Intracavernosal trazodone results in erectile activity that appears in part based on its local alpha blocking activity but like other intracavernosal alpha-blocking agents is not as effective in initiating penile erections as are intracavernosal agents that directly induce smooth muscle relaxation.

Adrenergic alpha-Antagonists↗

Intracavernous injection therapy: analysis of results and complications.

Experience with 100 patients who used intracavernous injection therapy with a combination of papaverine with or without phentolamine for 29 months is analyzed in detail. The largest group of patients had vasculogenic erectile failure (56%). At the end of followup 50% of the patients were no longer performing injection. Those who discontinued injection therapy were slightly older and had more vasculogenic erectile failure. The nonfibrotic complications were mild in all instances and did not result in discontinuation of injection therapy. These complications consisted of small hematomas in 20.9% of the patients, mild discomfort in 13.6% and mild liver enzyme abnormalities in 9.8%. No episode of priapism or infection occurred during therapy. Fibrotic complications consisted of nodules or plaques, and correlated significantly with the number of months on injection and the number of injections. At 12 months the fibrotic complication rate was 31 +/- 8.6%. Our study suggests caution regarding the long-term complication rate of intracavernous injection therapy with these compounds and underscores the importance of routine followup examinations. While injection therapy is an effective form of treatment for erectile failure, it is not a satisfactory alternative for many patients and is associated with a significant fibrotic complication rate.

Drug Therapy, Combination↗

Papaverine-induced fibrosis of the corpus cavernosum.

Intracorporeal papaverine self-injection is a new therapy for erectile dysfunction. Although reports of side effects are few, complications, such as priapism and fibrosis, have been described. We report a case of papaverine-induced obliteration of the corpus cavernosum with resulting inability to place a penile prosthesis.

Erectile Dysfunction↗

Intracavernous injection of prostaglandin E1 for the treatment of erectile impotence.

We administered intracavernous injections of 20 micrograms. prostaglandin E1 to 135 patients with impotence, and evaluated the effects and side effects. Among 135 patients who underwent intracavernous injection of prostaglandin E1 complete erection was observed in 83 (62 per cent), while incomplete erection was noted in 33 (24 per cent). In both groups the erection was sufficient for sexual intercourse. Tumescence without rigidity was noted in 12 patients and no response was obtained in 7. Poor response was seen frequently in patients with disorders of the vascular system and/or damage to the cavernous body of the penis. Priapism after the injection was not observed. Moreover, we never observed any other severe side effects. Intracavernous injection of prostaglandin E1 could be applicable to the therapy of impotence, especially that due to neurogenic disturbance. Since prostaglandin E1 acts quickly and loses its validity rapidly it is considered to be a more suitable agent than other vasoactive drugs.

Adult↗

Impotence evaluated by the use of prostaglandin E1.

We screened 80 patients at our hospital for the differential diagnosis of impotence using intracavernous injection of prostaglandin E1 (20 micrograms). The rate of positive response was 78.8 per cent (63 patients). Neither systemic reactions nor priapism occurred. However, a considerable incidence (23.8 per cent, 19 of 80 patients) of tolerable injection pain was encountered. The 133xenon penile washout study was conducted routinely in impotent men for hemodynamic evaluation of penile vascularity. In 80 patients a positive correlation between the response of intracavernous prostaglandin E1 injection and the result of the washout study was found (r equals 0.381, p less than 0.0002). We selected 14 subjects randomly to receive additional intravenous infusions of prostaglandin E1 (6 ampules, 120 micrograms total) for 3 days, after which another 133xenon washout study was done. The washout studies before and after intravenous prostaglandin E1 infusion were compared, and 10 patients (71.4 per cent) appeared to obtain improvement in half-time clearance and penile blood flow. However, only 3 patients noticed improvement subjectively. We suggest that prostaglandin E1 could be a desirable alternative for the diagnosis and treatment of impotence.

Adult↗

Intracavernous injection of prostaglandin E1 in impotent men.

Intracavernous injection of prostaglandin E1 was used in 210 men as a screening test for the differential diagnosis of vasculogenic impotence. Of these 210 patients 112 entered an autoinjection protocol for treatment of erectile dysfunction. Prostaglandin E1 appears to be effective in the diagnosis and treatment of nonvasculogenic impotence because it is a physiological agent that is metabolized locally within the cavernous tissue. Additionally, in our series neither systemic reactions nor priapism occurred, nor was fibrosis of cavernous tissue or scar formation observed after up to 90 injections.

Alprostadil↗

Pharmacological treatment of erectile dysfunction after radical prostatectomy.

The potential for potency after radical retropubic prostatectomy has improved considerably since the anatomical description of the neurovascular bundles to the penis and a technique whereby these nerves may be spared from injury. However, impotence remains an unavoidable complication in some patients. It is in such patients that we have chosen to evaluate the technique of intracavernosal injection of a papaverine/phentolamine mixture to obtain erections. After classical radical prostatectomy potency was restored by the injection technique in 12 of 14 patients (85 per cent). Three patients who failed to attain erections initially had successful results with larger doses. Two patients who failed to achieve erections had the lowest penile brachial index values and 1 in whom priapism developed had the highest value, indicating that this may be a useful technique to determine the initial dosage of the injection.

Drug Combinations↗

The application of intracavernous injection of vasoactive medications for erection in men with spinal cord injury.

Obtaining and sustaining an erection that is firm enough and adequate for vaginal penetration and satisfactory completion of intercourse are common problems for the male spinal cord injury patient. Intracavernous injection of vasoactive substances offers a new treatment option but it must be approached with caution in this population. During the last year we placed 20 spinal cord injury men (16 paraplegics and 4 quadriplegics) on self-injection of papaverine alone or with phentolamine. Of the patients 19 were able to obtain an erection adequate for penetration. The patient who did not obtain an adequate erection had anomalous penile venous drainage. Six episodes of priapism occurred in 3 patients: 1 had a surgical shunt placed elsewhere before he entered our program, and 2 were treated with aspiration of the corpora and injection of epinephrine. All 3 patients subsequently have been able to obtain satisfactory erections with use of lower doses of papaverine alone.

Adult↗

Intracavernous self-injection with phentolamine and papaverine for the treatment of impotence.

To evaluate the efficacy and safety of intracavernous self-injection of phentolamine and papaverine for the treatment of impotence, 30 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled cross-over study of papaverine and phentolamine versus normal saline. A total of 29 patients completed the study. The phentolamine plus papaverine combination resulted in erection in 24 patients (82.8 per cent) and no erection occurred after injection of saline. Of the patients 12 (41.4 per cent) experienced technical difficulties with the injection. Ecchymosis of the penis at the site of injection was common and 1 patient experienced priapism that resolved spontaneously. No other side effects occurred. Intracavernous self-injection with phentolamine and papaverine appears to be a safe and effective treatment of impotence but long-term effects must be determined.

Aged↗

Is intracavernous injection of papaverine a reliable screening test for vascular impotence?

To determine whether intracavernous injection of papaverine can discriminate vascular versus psychogenic impotence 80 mg. papaverine were injected intracorporeally into 27 impotent patients without any hormonal or neurological abnormality. The patients also underwent dynamic cavernosography, the artificial erection test and selective internal iliac arteriography. In addition, 21 of the patients underwent nocturnal penile tumescence monitoring. The response to intracavernous papaverine injection was noted as positive (fully rigid erection), intermediate or negative (soft or absent erection). Among 14 patients with severe arterial lesions and/or severe venous leakage the response was negative in 11 and positive in none. Among the remaining 13 patients (moderate or absent vascular abnormalities) the response was positive in 4 but negative in 4. Of 15 patients with an abnormal nocturnal penile tumescence test the response to intracavernous papaverine injection was negative in 12 and positive in none. However, of 6 patients with a normal nocturnal penile tumescence test the response was positive in only 1. Over-all, the results of the intracavernous papaverine injection test are correlated only fairly with those of the nocturnal penile tumescence test and the vascular investigations. This test could be useful to save some nocturnal penile tumescence tests in cases of suspected vascular impotence. However, the safety of this procedure must be confirmed in larger series. Indeed, 1 of our patients suffered priapism after a second intracavernous papaverine injection performed for a therapeutic purpose.

Adult↗

Auto-injection of the corpus cavernosum with a vasoactive drug combination for vasculogenic impotence.

Intracavernous injection of papaverine hydrochloride with phentolamine mesylate rapidly produces transitory penile tumescence, which can be followed by erection and coitus provided there is sexual stimulation. Coital penetration was possible in 59 of 62 patients with impotence of divers etiologies (vascular, diabetic, iatrogenic and Peyronie's disease) who underwent injection and were sent home to attempt coitus. One patient had a prolonged erection that was treated successfully with aspiration of a corpus. When coitus was successful the patient was offered training in self-injection. With self-injection 18 patients have had satisfactory coitus without a noteworthy complication; 5 for more than 12 months. The long-term effects of intracavernous injections remain unknown. Intracavernous injection of vasoactive substances (chemical prosthesis) may become a useful alternative treatment. Administration should be restricted to urologists able to manage the possible complication of priapism.

Aged↗