Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence
| Autor: | Douglas S. Hale, Tristi W. Muir, Holly E. Richter, Madhulika G. Varma, Ellen C. Wells, Mary L. Jannelli, Michelle M. Takase-Sanchez, Catherine A. Matthews, Douglas Van Drie |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Non-Randomized Controlled Trials as Topic Urology Logistic regression Odds Bowel control 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Humans Fecal incontinence Prospective Studies 030212 general & internal medicine Pelvic examination Aged Centimeter 030219 obstetrics & reproductive medicine medicine.diagnostic_test business.industry Obstetrics and Gynecology Prostheses and Implants Middle Aged Confidence interval Surgery Increased risk Vagina Female medicine.symptom business Fecal Incontinence |
| Zdroj: | Female Pelvic Medicine & Reconstructive Surgery. 22:359-363 |
| ISSN: | 2151-8378 |
| DOI: | 10.1097/spv.0000000000000290 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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