title: Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence.
abstract: We previously showed that management with a novel vaginal bowel control system was efficacious in women with moderate to severe fecal incontinence. The objective of this secondary analysis was to evaluate the clinical characteristics associated with device-fitting success.
  
  
  
  This is a secondary analysis of an institutional review board-approved, multicenter, prospective, open-label clinical study of women aged 19 to 75 years with 4 or more episodes of fecal incontinence recorded on a 2-week baseline bowel diary. Those successfully fitted with the vaginal bowel control device entered a 1-month treatment period, and efficacy was assessed with a repeat bowel diary. Demographic data, medical and surgical history, and pelvic examination findings were compared across women with successful and unsuccessful completion of the fitting period. Multivariate logistic regression analysis was performed.
  
  
  
  Six clinical sites in the United States recruited from August 2012 through October 2013. Overall, 110 women underwent attempted fitting, of which 61 (55.5%) of 110 were successful and entered the treatment portion of the study. Multivariate logistic regression analysis revealed that previous prolapse surgery (P = 0.007) and shorter vaginal length (P = 0.041) were independently associated with unsuccessful fitting. Women who have not undergone previous prolapse surgery had 4.7 times the odds (95% confidence interval [CI], 1.53-14.53) of a successful fit. In addition, for every additional centimeter of vaginal length, women had 1.49 times the odds (95% CI, 1.02-2.17) of a successful fit.
  
  
  
  Shorter vaginal length and previous prolapse surgery were associated with an increased risk of fitting failure. These findings may be used to inform patients regarding their expectation of successful fitting.
authors: From the *Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC; †Section of Colorectal Surgery, University of California, San Francisco, San Francisco, CA; ‡Department of Obstetrics and Gynecology, Indiana University Health, Indianapolis, IN; §Grand Rapids Women's Health, Grand Rapids, MI; ∥Department of Obstetrics and Gynecology, University of Texas Medical Branch, League City, TX; and ¶Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.
authors: Catherine A
authors: CA
authors: Matthews
authors: Madhulika G
authors: MG
authors: Varma
authors: Michelle M
authors: MM
authors: Takase-Sanchez
authors: Douglas S
authors: DS
authors: Hale
authors: Douglas
authors: D
authors: Van Drie
authors: Tristi
authors: T
authors: Muir
authors: Ellen
authors: E
authors: Wells
authors: Mary
authors: M
authors: Jannelli
authors: Holly E
authors: HE
authors: Richter
mesh_terms: D000368:Aged; D005242:Fecal Incontinence / Q000628:therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D065228:Non-Randomized Controlled Trials as Topic; D011446:Prospective Studies; D019736:Prostheses and Implants; D014621:Vagina