title: Botulinum toxin type A-a novel treatment for provoked vestibulodynia? Results from a randomized, placebo controlled, double blinded study.
abstract: BACKGROUND
  Vestibulodynia is an increasingly recognized problem among women and is often difficult to treat.
  
  
  OBJECTIVE
  This randomized, double blinded, placebo-controlled study aimed to evaluate the efficacy of Botox in the treatment of vestibulodynia.
  
  
  METHODS
  Sixty-four women were randomized to receive Botox (N = 32) or saline placebo (N = 32). Botulinum toxin A (20 I.E.) diluted in 0.5 mL saline or 0.5 mL saline was injected in the musculus bulbospongiosus at baseline.
  
  
  METHODS
  Pain was measured monthly on a visual analog scale (VAS) Likert scale. Sexual function was measured using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale at baseline and at 3 and 6 months follow up. Quality of life was measured using the 36-item short-form (SF-36).
  
  
  RESULTS
  Sixty women (94%) completed the 6 months follow up. Both Botox and placebo produced significantly pain reduction (P < 0.001). There was no significant difference in the median VAS score between the groups at 6 months follow up (P = 0.984). An improvement on the FSFI full score from baseline until 6 months was not significantly different between the groups (P = 0.635). In the placebo group a statistical significant larger reduction in sexual distress was observed from baseline until 6 months follow up compared to the Botox group (P = 0.044). No statistical significant differences were observed between the B- and P-groups in regard to the SF-36 scores.
  
  
  CONCLUSIONS
  Injection of 20 I.E. Botox in the vestibule of women diagnosed with vestibulodynia does not reduce pain, improve sexual functioning, or impact the quality of life compared to placebo and evaluated at 3 and 6 moths follow up. Both the Botox group and the placebo groups experienced a reduction in pain on the VAS Likert scale at 6 months follow up. Women with vestibulodynia have difficulty with sexual function and present with sexual distress, which has to be addressed in conjunction with pain to eliminate the disorder.
authors.affiliation: Sexological Clinic, Psychiatric Centre, Rigshospitalet University Hospital of Copenhagen, Copenhagen, Denmark. cdamsted@dadlnet.dk
authors.forename: Christina Damsted
authors.initials: CD
authors.lastname: Petersen
authors.forename: Annamaria
authors.initials: A
authors.lastname: Giraldi
authors.forename: Lene
authors.initials: L
authors.lastname: Lundvall
authors.forename: Ellids
authors.initials: E
authors.lastname: Kristensen
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D016015:Logistic Models; D015999:Multivariate Analysis; D009498:Neurotoxins / Q000627:therapeutic use*; D010147:Pain Measurement; D011594:Psychometrics; D012307:Risk Factors; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D019529:Sexuality; D013315:Stress, Psychological; D011795:Surveys and Questionnaires; D056650:Vulvodynia / Q000188:drug therapy*
chemical_list: D009498:Neurotoxins; D019274:Botulinum Toxins, Type A