Characteristics Associated with Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence

Catherine A. Matthews, Madhulika G. Varma, Michelle M. Takase-Sanchez, Douglas S. Hale, Douglas Van Drie, Tristi W. Muir, Ellen Wells, Mary Jannelli, Holly E. Richter

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Objectives 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. Methods 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. Results 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. Conclusions 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.

Original languageEnglish (US)
Pages (from-to)359-363
Number of pages5
JournalFemale Pelvic Medicine and Reconstructive Surgery
Issue number5
StatePublished - Sep 1 2016


  • accidental bowel leakage
  • conservative management
  • fecal incontinence
  • fitting characteristics
  • vaginal bowel control system

ASJC Scopus subject areas

  • Surgery
  • Obstetrics and Gynecology
  • Urology


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