title: Improvement in sexual quality of life of the female partner following vardenafil treatment of men with erectile dysfunction: a randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  Erectile dysfunction (ED) impacts on both members of the couple. Female partners of men with ED are more likely to report reduced sexual quality of life than women whose partners do not have ED.
  
  
  OBJECTIVE
  To assess vardenafil efficacy in men with ED and determine the effects of treatment on their female partner's sexual quality of life.
  
  
  METHODS
  Study participants comprised men aged 18-64 years with ED and their female partners. Eligible men had ED of ≥6 months' duration and a female partner who was motivated to support their ED treatment. Eligible women had a total Female Sexual Function Index score >23.55, indicating absence of significant sexual dysfunction. Following a 4-week screening period, men were randomized to treatment with vardenafil 10 mg or placebo, which could be titrated to 20 or 5 mg after 4 weeks.
  
  
  METHODS
  Primary efficacy variables were question 3 of the Sexual Encounter Profile questionnaire (SEP3) and the quality-of-life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL).
  
  
  RESULTS
  The intent-to-treat population included 343 couples, with 168 and 175 men receiving vardenafil or placebo, respectively. Vardenafil treatment significantly improved both erection maintenance and the female partners' sexual quality of life. Least squares (LS) mean SEP3 overall success rates after 12 weeks of treatment were 9.5 (baseline) vs. 67.2 (week 12) and 12.4 (baseline) vs. 24.2 (week 12) in the vardenafil and placebo groups, respectively (P < 0.0001). In female partners, LS mean mSLQQ-QOL scores were 28.8 (baseline) vs. 68.2 (last observation carried forward [LOCF]) in the vardenafil group and 24.6 (baseline) vs. 40.5 (LOCF) in the placebo group (P < 0.0001).
  
  
  CONCLUSIONS
  Vardenafil treatment of men with ED improved both their erectile function and the sexual quality of life of their female partners.
authors.affiliation: Department of Urology, Hospital Carlos Haya, Malaga, Spain. amartinmorales@terra.es
authors.forename: Antonio
authors.initials: A
authors.lastname: Martín-Morales
authors.forename: Alessandra
authors.initials: A
authors.lastname: Graziottin
authors.forename: Gilbert Bou
authors.initials: GB
authors.lastname: Jaoudé
authors.forename: Frans
authors.initials: F
authors.lastname: Debruyne
authors.forename: Jacques
authors.initials: J
authors.lastname: Buvat
authors.forename: Manfred
authors.initials: M
authors.lastname: Beneke
authors.forename: Dieter
authors.initials: D
authors.lastname: Neuser
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D012725:Sexual Behavior / Q000523:psychology; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride; D055815:Young Adult
chemical_list: D007093:Imidazoles; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride