Double-blind trial of oral prostaglandin E1 on impotence]

The effect of oral prostaglandin E1 (limaprost) on erectile function was studied in a double-blind placebo controlled trial. Fifty one patients who agreed to participate were examined for their subjective symptoms and nocturnal erection was recorded using an erectometer at the beginning of the study, after an initial 6 week period, and again after a second 6 week period. Patients were randomly assigned to a group which received placebo followed by limaprost or to a group which received limaprost followed by placebo. Ten cases dropped out. In the remaining forty one patients, NPT during the limaprost phase was significantly different from that during the placebo phase. Patients with the history of diabetes mellitus, hypertension, or pelvic surgery showed relatively poor responses to oral prostaglandin E1. Oral prostaglandin E1 achieved 42.9% effectiveness in the psychogenic impotence, and this effectiveness is significantly higher than that of placebo. Oral prostaglandin E1 was suggested as an additional or alternative therapy in the management of psychogenic impotence. Psychogenic impotent who didn't respond to sex therapy and patients with slight organic causes would seem to benefit from oral prostaglandin treatment.     

Penile pharmacological duplex ultrasonography: a dose-effect study comparing papaverine, papaverine/phentolamine and prostaglandin E1.

Alternations of penile blood flow are believed to be the most frequent organic cause of erectile dysfunction. Penile duplex ultrasonography following intracavernous injection of a vasoactive agent is an accepted method for diagnosis of penile vascular dysfunction. To determine the diagnostic efficacy of commonly used vasoactive drugs we studied the hemodynamic effects of different dosages of papaverine, the combination of papaverine and phentolamine, and prostaglandin E1 in men with erectile dysfunction and men with normal erectile potency using color duplex ultrasonography. We concluded that 12.5 mg. papaverine and 10 micrograms. prostaglandin E1 are the drugs of choice to be used in conjunction with penile duplex ultrasonography because of optimal effects on cavernous arterial dilatation and low risk of prolonged erection. However, low dose papaverine or prostaglandin E1 has a limited value in evaluating veno-occlusive function.     

A prospective double-blind trial of intracorporeal papaverine versus prostaglandin E1 in the treatment of impotence

A randomized prospective, double-blind clinical trial was performed comparing intracorporeal injections of papaverine (30 mg. per ml.) with prostaglandin E1 (10 mcg. per ml.) as pharmacological treatment of impotence. A total of 15 men completed the study, receiving papaverine and prostaglandin E1 in a crossover design. Over-all, 9 of 15 evaluable patients had a full erection with either 1 or both drugs: 3 secondary to papaverine only, 2 to prostaglandin E1 only, and 4 to both drugs. No major complications were observed. We conclude that intracorporeal prostaglandin E1 may be used successfully to stimulate pharmacological erections and that it might be useful in patients not responding to intracorporeal papaverine.     

Intracavernous injection of prostaglandin E1 in combination with papaverine: enhanced effectiveness in comparison with papaverine plus phentolamine and prostaglandin E1 alone

We compared the erectile response to intracavernous injection of a combination of papaverine and prostaglandin E1 with that of a combination of papaverine and phentolamine (49 patients), and prostaglandin E1 alone (38). The degree of erection achieved was significantly better with papaverine plus prostaglandin E1 than with papaverine plus phentolamine and the duration of erection was less, although the incidence of prolonged erections (greater than 5 hours) was similar with both combinations. Papaverine with prostaglandin E1 likewise resulted in a significantly better degree of erection than prostaglandin E1 alone (prolonged erections occurred only after the drug combination). All erections subsided spontaneously and none required medical intervention throughout the study. Pain was noted only after injection of prostaglandin E1. The incidence was clearly lower (7 of 38 versus 13 of 38) after the injection of only 5 micrograms. prostaglandin E1 in combination with papaverine (although the difference is not statistically significant). Subjectively, the side effects caused by the drug combination were described as much less dramatic by the patients than after prostaglandin E1 alone. The combination of papaverine and prostaglandin E1 shows a clearly synergistic effect and might suitably replace papaverine plus phentolamine or prostaglandin E1 alone in patients who do not respond well or suffer side effects after high single doses.     

Aorto-iliac/femoral reconstructions in patients with vasculogenic impotence

One hundred and forty-eight patients out of 386 undergoing aorto-iliac or aortofemoral bypass had preoperative impotence, 37 of these were diabetics. In all of them Doppler studies revealed a penile/brachial pressure index less than 0.6 and an abnormal waveform analysis. Nocturnal penile tumescence was investigated in 44 cases and found to be abnormal. Angiography showed unilateral or bilateral obstructive lesions of the hypogastric arteries in 80%, in addition to aortic, common and external iliac and femoral lesions. One hundred and thirty patients (87.8%) had straight aorto-iliac/femoral bypass grafts inserted without a direct attempt to revascularise the hypogastric arteries but 24 had distal anastomoses to the bifurcation of the common iliac artery. In the remaining 18 patients the hypogastric artery was reconstructed on one side by an additional bypass or reimplantation on the graft. In 22 of 106 patients (20.7%) undergoing aortofemoral bypass, 18 of 24 (75%) with the distal anastomosis to the iliac bifurcation, and 14 of the 18 (77.7%) with revascularisation of the hypogastric arteries, erectile function was regained. A good result was obtained in only five of the diabetic patients (13.5%). Our experience suggests that: (1) impotence, as indicated by non-invasive investigations, was vasculogenic in origin since patients with the most effective revascularisation of the hypogastric arteries had the best results; (2) when it is feasible, revascularisation of the hypogastric arteries should be carried out more often, during the aorto-iliac or aortofemoral reconstructions, particularly in younger impotent patients; (3) aorto-iliac revascularisation restores potency in only a few diabetic patients.     

Diagnosis of vasculogenic impotence: combination of penile xenon-133 washout and papaverine tests

The present study evaluates both penile xenon-133 washout (XWT) and papaverine tests (PT) in the diagnosis of vasculogenic impotence. XWT was accomplished by subcutaneous injection of xenon-133 (1-2 mCi in 0.1 mL saline solution) into the dorsal coronal prepuce. Abnormal XWT was suggested in patients whose clearance time (T1/2) was longer than 7.5 minutes and whose penile blood flow rate (Q) was less than 6 mL/100 g tissue/min. PT was done by intracavernous injection of papaverine (60 mg in 20 mL normal saline). Abnormal PT was indicated in patients whose onset of full erection was more than ten minutes after papaverine injection and whose duration of erection was less than one hour. Ten young and 11 older normal volunteers were examined with XWT only; all showed normal results. A total of 60 impotent patients were examined with both XWT and PT and were classified into four groups: in 2 patients (3.3%) both XWT and PT were normal (group I); in 8 (13.3%) XWT was abnormal and PT normal (group II); in 14 (23.3%) XWT was normal and PT abnormal (group III); and in 36 (60%) both XWT and PT were abnormal (group IV). On further examination with bilateral hypogastric arteriography in 10 XWT-abnormal patients and on surgical correction of abnormal curvature in 5 XWT-abnormal patients, all (100%) were proved to have penile arterial insufficiency. Erection cavernosography performed in 15 PT-abnormal patients confirmed penile venous insufficiency in 80 percent. We conclude both XWT and PT are simple and effective for evaluation of the penile arterial blood flow and venous competence, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)     

Comparative value of prostaglandin E1 and papaverine in treatment of erectile failure: double-blind crossover study among Egyptian patients.

In a double-blind, crossover designation penile intracavernous prostaglandin E1 and papaverine hydrochloride were compared in regard to effectiveness and safety in 52 patients investigated and treated for sexual erectile dysfunction. In evidence of the reliable effectiveness, prostaglandin E1 (20 micrograms/ml.) induced significant positive erectile response in 42 of 52 patients (81%). This rate reached 100% with neurogenic, hyperprolactinemic and/or psychogenic impotence. However, with papaverine hydrochloride (30 mg./ml.) and exclusively in cases of vasculogenic (most probably arteriogenic) impotence, negative erectile response was revealed as absent erection in 6 of 52 patients (11.5%) and nonrigid tumescence in 13 (25%) versus 2 (3.8%) and 8 (15.4%), respectively, with prostaglandin E1. Moreover, with prostaglandin E1 the regional pain was tolerable and transient, and the positive erectile response was not attended by priapism even in patients who formerly had priapism with papaverine hydrochloride. However, presently with prostaglandin E1 the relatively higher cost and shorter expiration period would probably limit its diagnostic and therapeutic use in Egypt, and probably in other developing countries.     

Double-blind study comparing indoramin and propranolol in the treatment of black patients with hypertension

A 20-week double-blind randomised study of 50 black hypertensive patients was designed to compare the efficacy and safety of indoramin (Baratol; Wyeth/Ayerst) and propranolol in patients who did not respond to diuretic therapy alone. Indoramin (initial dose 50 mg/d) or propranolol (initial dose 80 mg/d) was added to the regimen of patients whose supine diastolic blood pressure (SDBP) remained elevated at 100- 200 mmHg after 2 weeks' treatment with a combination diuretic tablet (hydrochlorothiazide 50 mg plus amiloride HCl 5 mg). Supine systolic blood pressure (SSBP) and SDBP of all patients was successfully controlled (SDBP lowered to less than 95 mmHg) by daily doses that did not exceed 100 mg of indoramin or 160 mg of propranolol; over 90% of patients in each group achieved control with lower doses, i.e. 50-75 mg of indoramin or 80-120 mg of propranolol. Although heart rate decreased from baseline values by approximately 9/min with both agents, the decreases were not significantly different between the treatment groups, and neither agent caused orthostatic hypotension. There were no statistically significant differences between the groups in the types or frequency of side-effects. Indoramin is well tolerated and is as effective as propranolol in black patients with essential hypertension who are not controlled by a thiazide diuretic alone.     

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.     

Intracavernous injection of papaverine hydrochloride for impotence in patients with spinal cord injury

Twenty-one intracavernous injections of 40 or 60 mg papaverine hydrochloride were given to ten male paraplegics. Erection sufficient for coitus was achieved within a few minutes after 15 of the injections (71.4%). Tumescence of the penis lasted from 18 minutes to 48 hours and the penile tumescence of the patients who had reflective erection usually lasted longer than that of the patients who did not. The trial that lasted for 48 hours resulted in the fracture of the penis that was presumed to have occurred during coitus and it was treated operatively. Intracavernous injection of papaverine hydrochloride is available for the impotence of male paralegics, but both doctor and patient must be careful about the sensory disturbance of the penis to avoid penile injury during erection. Further studies are needed to establish safety and long-term efficacy, as well as to determine if histological change of cavernous body occurs by repeated injection.     

Prostaglandin E1 versus phentolamine/papaverine for the treatment of erectile impotence: a double-blind comparison

The use of intracavernous prostaglandin E1 was studied in 48 organically impotent men. Eight men with previous chemical priapism did not have chemically induced priapism at up to 4 times the minimum effective dose of prostaglandin E1. Of 15 men with arteriogenic impotence who had failed prior intracavernous phentolamine and papaverine therapy 10 had adequate erections with prostaglandin E1. A total of 25 men received intracavernous prostaglandin E1 and phentolamine plus papaverine in a double-blind fashion. Erections with prostaglandin E1 were equal or superior to those with phentolamine plus papaverine in each case.     

Objective double-blind evaluation of erectile function with intracorporeal papaverine in combination with phentolamine and/or prostaglandin E1.

We performed a double-blind, crossover study using objective measurements to compare maximum rigidity and duration of erections with papaverine hydrochloride in combination with phentolamine mesylate and/or prostaglandin E1. The rationale for the protocol was to combine a smooth muscle relaxant (papaverine) with either or both vasodilating agents (phentolamine and prostaglandin E1) commonly used for injection therapy. The 7 volunteer patients with organic impotence documented by abnormal nocturnal penile tumescence testing were injected with 0.5 to 1.0 ml. papaverine (30 mg./ml.) in combination with phentolamine (0.5 mg./ml.) and/or prostaglandin E1 (5 micrograms./ml.). Each patient received 2 injections on each of 2 testing dates; injection 2 was given after tumescence resulting from injection 1 had subsided completely. The medications were given in a randomized, counterbalanced order following double-blind procedures. Patients evaluated the erections subjectively. In addition, the RigiScan device was used to measure maximum rigidity and duration of erections. All patients observed increased duration of erections with both combinations containing prostaglandin E1. Analysis of RigiScan measurements showed no statistically significant differences for maximum rigidity (p greater than 0.1) but significantly greater duration of erections with papaverine plus prostaglandin E1, and papaverine plus phentolamine plus prostaglandin E1 compared to papaverine plus phentolamine (p less than 0.001). There was no statistical difference in rigidity or duration of erections between papaverine plus prostaglandin E1 and papaverine plus phentolamine plus prostaglandin E1. No patient reported significant penile pain with any of the injections. We conclude that the combination of papaverine and prostaglandin E1 produces erections of longer duration than papaverine plus phentolamine and that no additional benefit is gained by adding phentolamine to a combination of papaverine and prostaglandin E1. Further studies are in progress to define optimal dose response curves for papaverine and prostaglandin E1 as individual agents and in combination.     

Double-blind, placebo-controlled, cross-over study of flavoxate in the treatment of idiopathic detrusor instability

Detrusor instability occurs in approximately 10% of the adult population, producing troublesome symptoms. The pharmacotherapy currently available is usually only partially effective and cannot be adequately evaluated except under "blind" conditions because of the significant component attributable to placebo effects. The results of the present study revealed no advantage resulting from treatment with flavoxate, as assessed both subjectively and objectively. We suggest that this therapy does not appear to be beneficial in the medical management of detrusor instability.     

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.     

Cigarette smoking and other vascular risk factors in vasculogenic impotence

A total of 132 consecutive patients with erectile impotence underwent extensive evaluation, including vascular evaluation with intracavernous injection of papaverine and penile duplex ultrasonography, to determine the etiology of impotence. Three vascular risk factors, smoking, diabetes mellitus and hypertension, were investigated for their impact on vasculogenic impotence. The patients were divided into four groups: one with no risk factors, one with one vascular risk factor, one with two vascular risk factors, and one with all three risk factors. The results of penile vascular evaluation in these patient groups were compared. The incidence of penile vascular impairment was found to be higher in patients with one vascular risk factor than in those with none. The proportion of abnormal penile vascular findings significantly increased as the number of risk factors increased. These data confirm the important role of vascular risk factors, smoking, diabetes mellitus, and hypertension, in the pathogenesis of organic impotence.     

双功能超声和彩色多普勒显像对血管性阳萎的诊断分析

５９例阳萎患者海绵体内注射罂粟硷前后的双功能超声和彩色多普勒显像，与阴茎血压、灌注性阴茎海绵体造影和部分手术结果进行分析对比，发现１１例血管正常（１９％），１９例动脉功能不全（３２％），２９例静脉漏（４９％）。对阴茎海绵体双功能超声和彩色多普勒显像诊断血管性阳萎的临床价值作了探讨。