title: Vaginismus Treatment: Clinical Trials Follow Up 241 Patients.
abstract: BACKGROUND
  Vaginismus is mostly unknown among clinicians and women. Vaginismus causes women to have fear, anxiety, and pain with penetration attempts.
  
  
  OBJECTIVE
  To present a large cohort of patients based on prior published studies approved by an institutional review board and the Food and Drug Administration using a comprehensive multimodal vaginismus treatment program to treat the physical and psychologic manifestations of women with vaginismus and to record successes, failures, and untoward effects of this treatment approach.
  
  
  METHODS
  Assessment of vaginismus included a comprehensive pretreatment questionnaire, the Female Sexual Function Index (FSFI), and consultation. All patients signed a detailed informed consent. Treatment consisted of a multimodal approach including intravaginal injections of onabotulinumtoxinA (Botox) and bupivacaine, progressive dilation under conscious sedation, indwelling dilator, follow-up and support with office visits, phone calls, e-mails, dilation logs, and FSFI reports.
  
  
  METHODS
  Logs noting dilation progression, pain and anxiety scores, time to achieve intercourse, setbacks, and untoward effects. Post-treatment FSFI scores were compared with preprocedure scores.
  
  
  RESULTS
  One hundred seventy-one patients (71%) reported having pain-free intercourse at a mean of 5.1 weeks (median = 2.5). Six patients (2.5%) were unable to achieve intercourse within a 1-year period after treatment and 64 patients (26.6%) were lost to follow-up. The change in the overall FSFI score measured at baseline, 3 months, 6 months, and 1 year was statistically significant at the 0.05 level. Three patients developed mild temporary stress incontinence, two patients developed a short period of temporary blurred vision, and one patient developed temporary excessive vaginal dryness. All adverse events resolved by approximately 4 months. One patient required retreatment followed by successful coitus.
  
  
  CONCLUSIONS
  A multimodal program that treated the physical and psychologic aspects of vaginismus enabled women to achieve pain-free intercourse as noted by patient communications and serial female sexual function studies. Further studies are indicated to better understand the individual components of this multimodal treatment program. Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med 2017;5:e114-e123.
authors.affiliation: Dunbarton, NH, USA. Electronic address: ptpacik@verizon.net.
authors.forename: Peter T
authors.initials: PT
authors.lastname: Pacik
authors.affiliation: Department of Statistics, Des Moines University, Des Moines, IA, USA.
authors.forename: Simon
authors.initials: S
authors.lastname: Geletta
keywords: Dyspareunia; Female Sexual Pain; Genito-Pelvic Pain/Penetration Disorder; Penetration Disorder; Vaginismus; Vaginismus Treatment