The categories for response to a DATTA question are defined as follows: Established—this technology has been adequately evaluated and its (A) safety or (B) effectiveness is accepted as appropriate by the practicing medical community for the given indication in the specified patient population; Promising—given current knowledge, the (A) safety or (B) effectiveness of this technology appears to be appropriate for the given indication in the specified patient population; as more experience and long-term follow-up are accumulated, this interim rating will change; Investigational—there is no consensus on the (A) safety or (B) effectiveness of this technology to date, there is insufficient evidence to determine its appropriateness, or it warrants further study; use of this technology for the given indication in the specified patient population should be confined largely to research protocols; Doubtful—given current knowledge, the (A) safety or (B) effectiveness of this technology appears to be inappropriate for the given indication in the specified patient population; as more experience and long-term follow-up are accumulated, this interim rating will change; and Unacceptable—the (A) safety or (B) effectiveness of this technology is regarded by the practicing medical community as inappropriate for the given indication in the specified patient population.
For each question, any response category receiving 50% or more of the panel's votes was tested for a consensus by assuming that the DATTA panel is a sample from a broader population of experts. Using exact binomial probabilities, the likelihood of the observed vote was calculated if exactly 50% of the total population of experts support that response for that question. Hence, the null hypothesis is 50% of all experts support the response, and the alternative, one-tailed, hypothesis is that more than 50% of all experts support the response. Rejection of the null hypothesis, and acceptance of the alternative, is interpreted as evidence of a majority opinion in the total population of experts, and a consensus is achieved. If no consensus was found, the categories were reorganized and reanalyzed. The definitions of "promising" and "established" include the concept of "appropriate," while the "doubtful" and "unacceptable" definitions include the concept of "inappropriate." The original five categories were thus, if necessary, reorganized into three categories: "appropriate," "investigational," and "inappropriate"; the analysis of any category with 50% or more of the vote was performed. P values for the survey responses are as follows: question 1A, 22 appropriate responses out of 28, P<.0001, consensus for appropriate; question 1B, 19 established responses out of 28, P =.044, consensus for established; question 2A, 21 appropriate responses out of 28, P =.0063, consensus for appropriate; and question 2B, 19 established responses out of 28, P =.044, consensus for established. Six respondents offered no opinion for questions 1 and 2.
Zorgniotti AW, Lefleur RS. Auto-injection of the corpus cavernosum with a vasoactive drug combination for vasculogenic impotence . J Urol. 1985;133:39-41.
Sidi AA, Cameron JS, Duffy LM, Lange PH. Intracavernous drug-induced erections in the management of male erectile dysfunction: experience with 100 patients . J Urol. 1986;135:704-706.
Keogh EJ, Watters GR, Earle CM, et al. Treatment of impotence by intrapenile injections: a comparison of papaverine vs papaverine and phentolamine: a double-blind, crossover trial . J Urol. 1989;142:726-728.
Zentgraf M, Baccouche M, Junemann KP. Diagnosis and therapy of erectile dysfunction using papaverine and phentolamine . Urol Int.
1988:43;65-75.Link to Article
Orvis BR, Lue TF. New therapy for impotence . Urol Clin North Am. 1987;14:569-581.
Sidi AA. Vasoactive intracavernous pharmacotherapy . Urol Clin North Am. 1988;15:95-101.
Levine SB, Althof SE, Turner LA, et al. Side effects of self-administration of intracavernous papaverine and phentolamine for the treatment of impotence . J Urol. 1989;141:54-57.
Michal V, Kramar R, Pospichal J, Hejhal L. Arterial epigastricocavernous anastomosis for the treatment of sexual impotence . World J Surg.
1977;1:515-519.Link to Article
Virag R. Intracavernous injection of papaverine for erectile failure . Lancet
. 1982;2:938.Link to Article
Brindley GS. Cavernosal alpha-blockade: a new technique for investigating and treating erectile impotence . Br J Psychiatry
. 1983;143:332-337.Link to Article
Virag R, Frydman D, Legman M, Virag H. Intracavernous injection of papaverine as a diagnostic and therapeutic method in erectile failure . Angiology
. 1984;35:79-87.Link to Article
Krane RJ, Goldstein I, Saenz de Tejada I: Impotence . N Engl J Med.
1989;321:1648-1659.Link to Article
Drug Evaluations . 6th ed. Chicago, Ill: American Medical Association; 1986: chap 45 .
Saenz de Tejada I, Goldstein I, Azadzoi K, Krane RJ, Cohen RA. Impaired neurogenic and endothelium-mediated relaxation of penile smooth muscle from diabetic men with impotence . N Engl J Med.
1989;320;1025-1030.Link to Article
Coffman JD. Drug therapy: vasodilator drugs in peripheral vascular disease . N Engl J Med.
1979;300:713-717.Link to Article
Lue TF, Hricak H, Schmidt RA, Tanagho EA. Functional evaluation of penile veins by cavernosography in papaverine-induced erection . J Urol. 1986;135;479-482.
Juenemann KP, Lue TF, Fournier GR Jr, Tanagho EA. Hemodynamics of papaverine and phentolamine-induced penile erection . J Urol. 1986;136:158-161.
Delcour C, Wespes E, Vandenbosch G, Schulman CC, Struyven J. The effect of papaverine on arterial and venous hemodynamics of erection . J Urol. 1987;138:187-189.
Hoffman BB, Lefkowitz RJ. Alpha-adrenergic receptor subtypes . N Engl J Med.
1980;302:1390-1396.Link to Article
Lue TF, Tanagho EA. Physiology of erection and pharmacological management of impotence . J Urol. 1987;137:829-836.
Kursh ED, Bodner DR, Resnick MI, et al. Injection therapy for impotence . Urol Clin North Am. 1988;15:625-629.
Janosko EO. Intracavernous self-injection of papaverine and Regitine for the treatment of organic impotence . NC Med J. 1986;47:305-307.
Robinette MA, Moffat MJ. Intracorporal injection of papaverine and phentolamine in the management of impotence . Br J Urol.
1986;58:692-695.Link to Article
Kiely EA, Ignotus P, Williams G. Penile function following intracavernosal injection of vasoactive agents or saline . Br J Urol.
1987;59:473-476.Link to Article
Lakin MM, Montague DK. Intracavernous injections of papaverine and phentolamine: correlation with penile brachial index . Urology.
1989;33:383-386.Link to Article
Nellans RE, Ellis LR, Kramer-Levien D. Pharmacological erection: diagnosis and treatment, applications in 69 patients . J Urol. 1987;138:52-54.
Larsen EH, Gasser TC, Bruskewitz RG. Fibrosis of corpus cavernosum after intracavernous injection of phentolamine/papaverine . J Urol. 1987; 137:292-293.
Hu KN, Burks C, Christy WC. Fibrosis of tunica albuginea: complication of long-term intracavernous pharmacological self-injection . J Urol. 1987;138:404-405.
Fuchs ME, Brawer MK. Papaverine-induced fibrosis of the corpus cavernosum . J Urol. 1989;141:125.
Seidmon EJ, Samaha AM Jr. The pH analysis of papaverine-phentolamine and prostaglandin E1, for pharmacologic erection . J Urol. 1989;141:1458-1459.
Ronnov-Jessen V, Tjernlund A. Hepatotoxicity due to treatment with papaverine, report of four cases . N Engl J Med.
1969;281:1333-1335.Link to Article
Driemen PM. Papaverine—hepatotoxic or not? J Am Geriatr Soc. 1973;21:202-205.
Waldhauser M, Schramek P. Efficiency and side effects of prostaglandin EI in the treatment of erectile dysfunction . J Urol. 1988;140:525-527.
Lee LM, Stevenson RWD, Szasz G. Prostaglandin E1 vs phentolamine/papaverine for the treatment of erectile impotence: a double-blind comparison . J Urol. 1989;141:549-550.
Sarosdy MF, Hudnall CH, Erickson DR, Hardin TC, Novicki DE. A prospective double-blind trial of intracorporeal papaverine vs prostaglandin E1 in the treatment of impotence . J Urol. 1989;141:551-553.