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.
Successful fitting of a novel vaginal bowel control device for fecal incontinence was less likely in women with shorter vaginal length and previous prolapse surgery.
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.
Reprints: Catherine Matthews, MD, 1211 W 4th St, Winston Salem, NC 27101. E-mail: firstname.lastname@example.org.
All authors except Dr. Varma received an industry sponsored grant from Pelvalon.
The authors have declared they have no conflicts of interest.
Clinical trial registration: NCT01655498 (http://clinicaltrials.gov).
Paper presentation: podium presentation, 2014 International Continence Society Annual Meeting, Rio De Janeiro, Brazil, October 20 to 24, 2014. Podium presentation and winner of Best Urogynecology Abstract, American Association of Gynecologic Laparoscopists Annual Meeting, Vancouver, British Columbia, Canada, November 2014.