Clinical trial NCT04829721: Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women
Official title: Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Patient Education
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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. Group learning through a class focused on behavioral modification and pelvic floor muscle exercises for women with urinary incontinence, has been shown to be an effective means to educate women about urinary incontinence management. The PAKS study hopes to demonstrate whether Spanish-speaking women that undergo an informative workshop on pelvic floor disorders via video in Spanish are more likely to raise their level of knowledge surrounding pelvic floor disorders and improve the pelvic floor symptoms.

Detailed description: Purpose: The purpose of this study is to determine if an informational workshop on pelvic floor disorders administered via a video intervention 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 immediately post-intervention and at 4 weeks post-intervention compared to a pre-intervention knowledge.

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.

Eligibility criteria: Inclusion Criteria:

* Women 18 years or older
* Interested in learning about pelvic floor disorders
* Spanish-speaking.

Exclusion Criteria:

* Women under 18 years of age
* Have previously completed the Prolapse and Incontinence Knowledge Questionnaire
* Unable to speak Spanish

Primary outcomes:
measure: Pelvic Floor Knowledge Scores Immediately Postintervention
timeFrame: Immediately after intervention administered
Secondary outcomes:
measure: Pelvic Floor Knowledge Scores at 4 Weeks Postintervention
timeFrame: At 4 weeks postintervention
measure: Pelvic Floor Symptom Scores at 4 Weeks Postintervention
timeFrame: At 4 weeks postintervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Keila S Muniz, MD
role: STUDY_DIRECTOR
References:
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