Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Patient Education
  • Pelvic Organ Prolapse
  • Urinary Incontinence
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Masking Description: As participants and care providers could not be blinded to the intervention assigned and received, masking of participants to the study hypotheses and existence of a placebo arm will be performed.Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Purpose: The purpose of this study is to determine if an informational workshop on pelvic floor disorders administered via a video intervention versus standard-of-care educational handouts will increase Spanish-speaking women's knowledge of pelvic floor disorders and decrease pelvic floor symptoms p...

Purpose: The purpose of this study is to determine if an informational workshop on pelvic floor disorders administered via a video intervention versus standard-of-care educational handouts will increase Spanish-speaking women's knowledge of pelvic floor disorders and decrease pelvic floor symptoms post-intervention. Hypothesis or Aim: A single 20 minute video workshop on pelvic floor disorders will improve Spanish-speaking women's knowledge of pelvic floor disorders compared immediately post-intervention and at 4 weeks postintervention compared to a control group receiving standard-of-care educational handouts who do not participate in the video workshop. Justification of the Study (Background): It is estimated that by the year 2050 in the United States, 58.2 million women will have at least 1 pelvic floor disorder. However, understanding of these disorders among patients is low. Prior studies assessing patient knowledge have shown that participants often did not understand basic urogynecologic terms such as urinary incontinence, pelvic organ prolapse, and pelvic floor disorder and that the participants had poor knowledge of participants' conditions. Latinos will comprise 30% of the population in the United States by year 2060. In Hispanic women, barriers such as lower income, lower education, limited English language proficiency and lack of health coverage influence access to health care. In those with pelvic floor disorders, additional barriers such as poor understanding of general medical conditions, medical terminology, and female anatomy may lead to low understanding of participants' condition, treatment options, and therapies. Given this high prevalence estimate, educating and optimizing care for Hispanic women with such disorders is imperative with implications of having a significant societal impact. Pelvic floor health workshops have previously been shown to be effective in improving postpartum knowledge, performance of pelvic floor muscle exercises, and bowel-specific quality of life. Learning through a class focused on behavioral modification and pelvic floor muscle exercises for women with urinary incontinence, was shown to be an effective means to educate women about urinary incontinence management. Women's knowledge, symptoms, and quality-of-life scores significantly improved at 3 months after undergoing an educational pelvic health workshop on incontinence and pelvic organ prolapse. Currently, no studies have investigated the effects of a formal educational pelvic floor disorder workshop in Spanish on this knowledge or its impact on patient symptoms in those who suffer from pelvic floor disorders at baseline. The investigators research project proposes to close the gap between patient knowledge and scientific knowledge and potentially improve pelvic floor symptoms. The investigators' video workshop will empower women with knowledge and allow the women to make informed decisions surrounding the women's pelvic floor health. It will provide the women with tools to improve the women's own pelvic floor health. A pelvic floor health workshop targeted to Spanish-speaking women is an innovative concept which could lead to better patient care in a growing population. It may be the first step in prevention of future pelvic floor conditions. The target population is Spanish-speaking women, 18 years or older with 66 women being recruited. Sampling method: All participants will be randomized to two groups, the random allocation lists will be generated by a statistician unassociated with the study. The allocations will be loaded onto a computer and access by study team members via REDCap. Interactions between the study team members and the REDCap system will be logged, including the time and date, a patient identifier (patient letter code) and the treatment allocation.

Tracking Information

NCT #
NCT04829721
Collaborators
Not Provided
Investigators
Study Director: Keila S Muniz, MD Johns Hopkins University