Objective  To examine the safety and efficacy of transurethral pharmacotherapy for erectile dysfunction, involving the use of a novel therapeutic system to administer alprostadil (prostaglandin E1) to the urethral mucosa in a double‐blind, randomized, parallel, placebo‐controlled study conducted in five countries in Europe. Patients and methods  In an outpatient setting, patients with primarily organic erectile dysfunction of at least 3 months’ duration were treated with transurethral alprostadil, in an open‐label, dose‐escalating study. Testing stopped when the dose provided an erection sufficient for intercourse, as assessed by the patient and the investigator. Patients who achieved a sufficient response were then randomized to either active medication at the selected dose or to placebo for use at home for 3 months. After each home administration, patients recorded in diaries whether or not sexual intercourse occurred and any adverse reactions to the drug. Results  A total of 249 patients were treated in an outpatient setting; of these patients, 159 (64%) achieved an erection sufficient for intercourse and were randomized (1:1) to either active medication or placebo for home treatment. Of the patients randomized to alprostadil for home treatment, 69% reported intercourse at least once, compared with 11% of patients randomized to placebo (P<0.001). The most common adverse reaction, urethral pain/burning, was reported by 7% of patients in the clinic. Most patients (83%) graded transurethral alprostadil as causing minimal or no discomfort in the clinic. No patient reported priapism or developed penile fibrosis. Conclusion  Alprostadil delivered transurethrally by this system was well tolerated and effective in treating erectile dysfunction.

Objective To evaluate the impact of treatment for erectile dysfunction on the quality of life of men and their partners. Patients and methods The study included 249 men with organic erectile dysfunction of more than 3 months’ duration who self‐administered transurethral alprostadil in an open‐label, dose‐escalating manner in an outpatient medical setting. Patients with a sufficient response (159) were randomly assigned in a double‐blind protocol to either active medication or placebo for 3 months at home. Patients and partners each completed quality‐of‐life questionnaires before and after treatment. Results In the clinic 159 of the 249 men (64%) had an erection sufficient for intercourse when using transurethral alprostadil. At home, 46 of 67 men (69%) reported intercourse at least once on transurethral alprostadil, compared with eight of 73 (11%) on placebo (P<0.001). Patients on alprostadil showed a 34% improvement in their ‘relationship with partner’, a 5% improvement in ‘personal wellness’, and a 71% improvement in ‘quality of erection’ domains, compared with a decline of 11%, 8% and 1%, respectively, in patients on placebo (P<0.005 for each comparison). Partners of patients on alprostadil showed a 35% improvement in the ‘relationship with partner’ domain, compared with a 12% improvement in the placebo group (P=0.028). There was a trend toward improvement in other partner domains. Urogenital pain was reported by 14% of patients during home treatment. Conclusion The resumption of sexual intercourse with the use of transurethral alprostadil was accompanied by an improvement in several important quality‐of‐life domains in patients and their partners.