title: Treatment of men with erectile dysfunction with transurethral alprostadil. Medicated Urethral System for Erection (MUSE) Study Group.
abstract: BACKGROUND
  Erectile dysfunction in men is common. We evaluated a system by which alprostadil (prostaglandin E1) is delivered transurethrally to treat this disorder.
  
  
  METHODS
  Alprostadil was delivered transurethrally in a double-blind, placebo-controlled study of 1511 men, 27 to 88 years of age, who had chronic erectile dysfunction from various organic causes. The men were first tested in the clinic with up to four doses of the drug (125, 250, 500, and 1000 microg); those who had sufficient responses were randomly assigned to treatment with either the effective dose of alprostadil or placebo for three months at home.
  
  
  RESULTS
  During in-clinic testing, 996 men (65.9 percent) had erections sufficient for intercourse. Of these men, 961 reported the results of at least one home treatment; 299 of the 461 treated with alprostadil (64.9 percent) had intercourse successfully at least once, as compared with 93 of the 500 who received placebo (18.6 percent, P<0.001). On average, 7 of 10 alprostadil administrations were followed by intercourse in men responsive to treatment. The efficacy of alprostadil was similar regardless of age or the cause of erectile dysfunction, including vascular disease, diabetes, surgery, and trauma (P<0.001 for all comparisons with placebo). The most common side effect was mild penile pain, which occurred after 10.8 percent of alprostadil treatments, but the pain rarely resulted in refusal to continue in the study. Hypotension occurred in the clinic in 3.3 percent of men receiving alprostadil. Hypotension-related symptoms were uncommon at home. No men had priapism or penile fibrosis.
  
  
  CONCLUSIONS
  In men with erectile dysfunction, transurethral alprostadil therapy resulted in erections in the clinic and in intercourse at home.
authors.affiliation: Department of Urology, University of Southern California, Los Angeles, USA.
authors.forename: H
authors.initials: H
authors.lastname: Padma-Nathan
authors.forename: W J
authors.initials: WJ
authors.lastname: Hellstrom
authors.forename: F E
authors.initials: FE
authors.lastname: Kaiser
authors.forename: R F
authors.initials: RF
authors.lastname: Labasky
authors.forename: T F
authors.initials: TF
authors.lastname: Lue
authors.forename: W E
authors.initials: WE
authors.lastname: Nolten
authors.forename: P C
authors.initials: PC
authors.lastname: Norwood
authors.forename: C A
authors.initials: CA
authors.lastname: Peterson
authors.forename: R
authors.initials: R
authors.lastname: Shabsigh
authors.forename: P Y
authors.initials: PY
authors.lastname: Tam
authors.forename: V A
authors.initials: VA
authors.lastname: Place
authors.forename: N
authors.initials: N
authors.lastname: Gesundheit
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000527:Alprostadil / Q000008:administration & dosage* / Q000009:adverse effects; D003075:Coitus; D004311:Double-Blind Method; D004333:Drug Administration Routes; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014521:Urethra
chemical_list: D000527:Alprostadil