Browsing by Author "Pelvic Floor Disorders Network"

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Open Access
A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery.
(Obstetrics and gynecology, 2014-02) Jelovsek, J Eric; Chagin, Kevin; Brubaker, Linda; Rogers, Rebecca G; Richter, Holly E; Arya, Lily; Barber, Matthew D; Shepherd, Jonathan P; Nolen, Tracy L; Norton, Peggy; Sung, Vivian; Menefee, Shawn; Siddiqui, Nazema; Meikle, Susan F; Kattan, Michael W; Pelvic Floor Disorders Network
To construct and validate a prediction model for estimating the risk of de novo stress urinary incontinence (SUI) after vaginal pelvic organ prolapse (POP) surgery and compare it with predictions using preoperative urinary stress testing and expert surgeons' predictions.Using the data set (n=457) from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial, a model using 12 clinical preoperative predictors of de novo SUI was constructed. De novo SUI was determined by Pelvic Floor Distress Inventory responses through 12 months postoperatively. After fitting the multivariable logistic regression model using the best predictors, the model was internally validated with 1,000 bootstrap samples to obtain bias-corrected accuracy using a concordance index. The model's predictions were also externally validated by comparing findings against actual outcomes using Colpopexy and Urinary Reduction Efforts trial patients (n=316). The final model's performance was compared with experts using a test data set of 32 randomly chosen Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial patients through comparison of the model's area under the curve against: 1) 22 experts' predictions; and 2) preoperative prolapse reduction stress testing.A model containing seven predictors discriminated between de novo SUI status (concordance index 0.73, 95% confidence interval [CI] 0.65-0.80) in Outcomes Following Vaginal Prolapse Repair and Midurethral Sling participants and outperformed expert clinicians (area under the curve 0.72 compared with 0.62, P<.001) and preoperative urinary stress testing (area under the curve 0.72 compared with 0.54, P<.001). The concordance index for Colpopexy and Urinary Reduction Efforts trial participants was 0.62 (95% CI 0.56-0.69).This individualized prediction model for de novo SUI after vaginal POP surgery is valid and outperforms preoperative stress testing, prediction by experts, and preoperative reduction cough stress testing. An online calculator is provided for clinical use.III.
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
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.
Open Access
Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol
(Neurogastroenterology and Motility, 2017-01-01) Markland, AD; Jelovsek, JE; Whitehead, WE; Newman, DK; Andy, UU; Dyer, K; Harm-Ernandes, I; Cichowski, S; McCormick, J; Rardin, C; Sutkin, G; Shaffer, A; Meikle, S; Pelvic Floor Disorders Network
Background: Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI. Methods: In a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. Key Results: Twenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. Conclusions & Inferences: A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings.
Open Access
Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence.
(Female Pelvic Med Reconstr Surg, 2017-08-01) Markland, Alayne D; Jelovsek, J Eric; Rahn, David D; Wang, Lu; Merrin, Leah; Tuteja, Ashok; Richter, Holly E; Meikle, Susan; Pelvic Floor Disorders Network
OBJECTIVES: The objectives of this work were to determine the prevalence of irritable bowel syndrome (IBS) and IBS subtypes in women presenting for fecal incontinence (FI) treatment and to assess the impact of IBS on FI symptoms and quality of life (QOL). METHODS: In this multicenter prospective cohort study, women reported at least monthly solid, liquid, or mucus FI. Rome III clinical criteria defined IBS. Women also self-reported having an IBS diagnosis. Baseline questionnaires included the following: Modified Manchester Health Questionnaire, Fecal Incontinence Severity Index, Bristol Stool Scale, Pelvic Floor Distress Inventory, and the Pelvic Floor Impact Questionnaire. RESULTS: Of the 133 women enrolled, 119 completed Rome III IBS questionnaires, and 111 reported on whether they had a previous diagnosis of IBS. The prevalence of IBS was 31% (95% confidence interval [CI], 22.9%-40.2%) according to the Rome III IBS criteria. The most common subtypes were IBS-mixed (41%) and IBS-diarrhea (35%). Twenty-four (22%) of 111 patients had a previous diagnosis of IBS. Among women who met Rome III IBS criteria, 23 (66%) of 35 women had never had a diagnosis of IBS. Women with FI and IBS reported significantly worse QOL compared to women without IBS despite similar FI severity and stool consistency. CONCLUSIONS: Irritable bowel syndrome negatively affects QOL and affects one third of women with FI presenting for care in tertiary centers. Our findings suggest that assessment of IBS symptoms and diagnosis may be important for women presenting for FI treatment.
Open Access
Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.
(Int Urogynecol J, 2016-10) Sung, Vivian W; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S; Moalli, Pamela; Newman, Diane K; Richter, Holly E; Ridgeway, Beri; Smith, Ariana L; Weidner, Alison C; Meikle, Susan; Pelvic Floor Disorders Network
INTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. METHODS: ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. RESULTS: The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. CONCLUSIONS: We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.