Patient Characteristics Associated With A Clinically Important Treatment Response in Women Under-going Non-surgical Therapy for Fecal Incontinence

Richter H E1, Jelovsek E2, Iyer P3, Rogers R G4, Meyer I1, Newman D K5, Bradley M6, Harm-Ernandes I2, Dyer K7, Wohlrab K8, Mazloomdoost D9, Gantz M3

Research Type


Abstract Category

Anorectal / Bowel Dysfunction

Abstract 661
Bowel Dysfunction and Sexual Function
Scientific Podium Short Oral Session 34
Friday 31st August 2018
15:20 - 15:27
Hall D
Anal Incontinence Clinical Trial Female Quality of Life (QoL)
1. Univ of Alabama at Birmingham, 2. Duke University, 3. Research Triangle Institute, 4. Univ of Texas, Austin, 5. Univ of Pennsylvania, 6. Univ of Pittsburgh, 7. Kaiser-Permanente, 8. Brown University, 9. National Institute of Child Health and Human Development for the Pelvic Floor Disorders Network

Holly E Richter



Hypothesis / aims of study
To identify clinical and demographic characteristics associated with a clinically important treatment response in women randomized in a 2x2 factorial design to loperamide or placebo and to and anal exercises with biofeedback vs. educational pamphlet for treatment of fecal incontinence (FI).
Study design, materials and methods
Data were analyzed from the Controlling Anal incontinence by Performing Anal Exercises with Biofeedback or Loperamide (CAPABLe) trial. In this analysis, treatment response was defined in two ways: as a clinically important improvement of -5 points in St. Mark’s scores, and as a ≥50% reduction in FI episodes, from baseline to 24 weeks. Multivariable logistic regression models included baseline characteristics and clinical variables significant at p≤0.2 on bivariate analysis, and treatment group. Treatment x predictor interactions were evaluated for one predictor at a time. Adjusted odds ratios (aOR) are presented with 95% confidence intervals (CI).
Overall, mean age was 63.8±11.1 years, 79.3% were White, mean BMI 29.8±7.0 and 85.3% were postmenopausal. Characteristics associated with treatment response on logistic regression analyses are presented in the table. Treatment response by St. Mark’s score was independently associated with being overweight (BMI 25 to 29.9) vs normal or underweight (BMI<25), no previous cesarean section (C/S), and higher baseline St. Mark’s score. When St. Mark’s score was assessed as a continuous variable, there was an estimated improvement at 24 weeks of -0.86 points in the St Mark’s score for each 1-point increase in baseline sphincter tone (95% CI -1.42, -0.30) and an improvement of -0.65 points in the St Mark’s score for each 1-point increase in baseline score (95% CI -0.80, -0.50). Being in the combined loperamide/biofeedback group vs control (placebo/educational pamphlet) group was independently associated with achieving a 50% reduction in FI episodes.
Interpretation of results
Certain clinical and demographic variables were associated with treatment response. Being overweight (compared to normal or underweight), history of C/S and increased clinical severity were associated with a minimally important clinical difference in the St Mark’s score. Receiving both active treatments was associated with a 50% reduction in FI episodes.
Concluding message
Overweight BMI, no history of C/S, severity of FI symptoms and combined active treatments were associated with treatment response in women randomized to loperamide vs. placebo, and biofeedback vs. education. This information may assist in counseling patients regarding the efficacy and expectations of conservative treatment modalities for women with FI.
Figure 1
Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development Clinical Trial No Subjects Human Ethics Committee Institutional Review Board Helsinki Yes Informed Consent Yes