Background
Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat fecal incontinence.
Methods
In a Pelvic Floor Disorders Network (PFDN) trial, participants 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. Post-certification, 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 pre-specified 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.
Objective: To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of non-surgical therapies for fecal incontinence (FI).Methods: Women (N=296) with FI were randomized to loperamide or placebo and manometryassisted biofeedback exercises or educational pamphlet in a 2×2 factorial design. Treatment response was defined in 3 ways: minimally clinically important difference (MID) of −5 points in St. Mark's score, ≥50% reduction in FI episodes and combined St. Mark's MID and ≥50% reduction FI episodes, from baseline to 24 weeks. Multivariable logistic regression models included baseline characteristics and treatment group with and without controlling for drug and exercise adherence.Results: Treatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted Odds Ratio [aOR] 1.20, 95%CI 1.11 -1.28) and being overweight vs normal/ underweight (aOR 2.15, 95%CI 1.07 -4.34); these predictors remained controlling for adherence. 50% reduction in FI episodes was associated with combined loperamide/biofeedback group compared to placebo/pamphlet (aOR 4.04,, St. Mark's score in the placebo/ pamphlet group (aOR 1.29, 95%CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95%CI 1.09-5.25) and passive vs urge plus passive FI, (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score.
Conclusion:Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients regarding efficacy and expectations of non-surgical treatments of FI.
Objectives
This study aimed to assist practitioners in performing an accurate assessment of the external and internal pelvic musculoskeletal (MSK) systems to improve appropriate diagnosis and referral of patients with pelvic floor disorders or pelvic pain and to improve understanding of physical therapy (PT) treatment principles, thereby improving communication between practitioners and encouraging a multidisciplinary approach.
Methods
A referenced review of the anatomy of the pelvic floor muscles, pelvis, and surrounding structures, followed by a detailed assessment of anatomy, posture, and gait, is presented. A thorough description of PT assessment and treatment is included with clinical relevance.
Results
When proper assessments are routinely performed, MSK conditions can be recognized, allowing for prompt and appropriate referrals to PT. Assessment and treatment by qualified physical therapists are integral to pelvic health care. After efficient medical assessment, MSK dysfunction can be addressed expeditiously, thereby avoiding further decline. Left unaddressed, pelvic dysfunction may become chronic.
Conclusions
We propose a guide for MSK assessment of the pelvis and associated structures that can be used for both clinical and research purposes. This guide is designed for health care providers caring for women with pelvic floor disorders, including physicians, advanced practice providers, and nurses. This guide serves to improve communication among multidisciplinary practitioners to refine MSK assessment and treatment approaches and thereby advance clinical care and research.
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