Browsing by Author "Gantz, Marie G"

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Open Access
Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods
(CONTEMPORARY CLINICAL TRIALS, 2015-09) Barber, Matthew Don; Dyer, K; Gantz, Marie G; Jelovsek, John E; Markland, Alayne D; Meikle, Susan; Network, PFD; Newman, DK; Rogers, RG; Sung, VW; Sutkin, G; Visco, Anthony Gabriele; Whitehead, WE
Open Access
Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.
(Contemp Clin Trials, 2015-09) Eric Jelovsek, J; Markland, Alayne D; Whitehead, William E; Barber, Matthew D; Newman, Diane K; Rogers, Rebecca G; Dyer, Keisha; Visco, Anthony; Sung, Vivian W; Sutkin, Gary; Meikle, Susan F; Gantz, Marie G; Pelvic Floor Disorders Network
The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence.
Open Access
Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial
(The Lancet Gastroenterology & Hepatology, 2019-07) Jelovsek, J Eric; Markland, Alayne D; Whitehead, William E; Barber, Matthew D; Newman, Diane K; Rogers, Rebecca G; Dyer, Keisha; Visco, Anthony G; Sutkin, Gary; Zyczynski, Halina M; Carper, Benjamin; Meikle, Susan F; Sung, Vivian W; Gantz, Marie G; National Institute of Child Health and Human Development Pelvic Floor Disorders Network
Open Access
Impact of treatment for Fecal Incontinence on Constipation Symptoms.
(American journal of obstetrics and gynecology, 2019-11-22) Andy, Uduak U; Jelovsek, J Eric; Carper, Benjamin; Meyer, Isuzu; Dyer, Keisha Y; Rogers, Rebecca G; Mazloomdoost, Donna; Korbly, Nicole B; Sassani, Jessica C; Gantz, Marie G; Pelvic Floor Disorders Network
OBJECTIVE:Defecatory symptoms, such as sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence (FI). Treatments for FI, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for FI with education only, loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and non-responders to FI treatment. METHODS:This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for FI in a 2x2 factorial design. Women with at least monthly FI and normal stool consistency were randomized to 4 groups: 1) oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline, 12 weeks and 24 weeks. The PAC-SYM consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to FI treatment were defined as women with a minimally important clinical improvement of ≥5-points on the St. Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in PAC-SYM scores from baseline through 24 weeks. RESULTS:At 24 weeks, there were small changes in PAC-SYM global scores in all four groups: oral placebo plus education (-0.3; 95% CI -0.5, -0.1), loperamide plus education (-0.1, 95% CI -0.3, 0.0), oral placebo plus biofeedback (-0.3, 95% CI -0.4, -0.2), and loperamide plus biofeedback (-0.3, 95% CI -0.4, -0.2). No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82). Change in PAC-SYM scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in PAC-SYM scores than non-responders (-0.4; 95% CI -0.5, -0.3 vs. -0.2; 95% CI -0.3, -0.0, p<0.01, mean difference 0.2, 95% CI 0.1, 0.4). CONCLUSION:Change in constipation symptoms following treatment of FI in women are small and are not significantly different between groups. Loperamide treatment for FI does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in FI symptoms report greater improvement in constipation symptoms.