PAKS: Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT04829721
Collaborator
(none)
114
1
1
8
14.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention with video
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Educational Video Workshop

A single 20 minute video workshop on pelvic floor disorders.

Other: Educational Intervention with video
Women randomized to an educational video workshop group.

Outcome Measures

Primary Outcome Measures

  1. Pelvic Floor Knowledge Scores Immediately Postintervention [Immediately after intervention administered]

    Difference in questionnaire scores based on the validated Spanish version of the Prolapse and Incontinence Knowledge Questionnaire from baseline compared to immediately post-intervention after an educational video workshop. The Prolapse and Incontinence Knowledge Questionnaire is a 24-item condition-specific questionnaire that consists of 2 knowledge subscales: questions concerning pelvic organ prolapse (score range 0-12) and urinary incontinence (score range 0-12). Each item is given a score of 1 if answered correctly and 0 if answered incorrectly. Women are given a score of 0 if they answered "I don't know" or "No lo sé" presuming a lack of knowledge. Higher scores mean greater knowledge of these pelvic floor disorders.

Secondary Outcome Measures

  1. Pelvic Floor Knowledge Scores at 4 Weeks Postintervention [At 4 weeks postintervention]

    Difference in questionnaire scores based on the validated Spanish version of the Prolapse and Incontinence Knowledge Questionnaire from baseline compared to 4 weeks post-intervention after an educational video workshop The Prolapse and Incontinence Knowledge Questionnaire is a 24-item condition-specific questionnaire that consists of 2 knowledge subscales: questions concerning pelvic organ prolapse (score range 0-12) and urinary incontinence (score range 0-12). Each item is given a score of 1 if answered correctly and 0 if answered incorrectly. Women are given a score of 0 if they answered "I don't know" or "No lo sé" presuming a lack of knowledge. Higher scores mean greater knowledge of these pelvic floor disorders.

  2. Pelvic Floor Symptom Scores at 4 Weeks Postintervention [At 4 weeks postintervention]

    Difference in Pelvic Floor Distress Inventory-20 questionnaire scores at 4 weeks postintervention from baseline compared to 4 weeks post-intervention after an educational video workshop The Pelvic Floor Distress Inventory-20 is a set of 20 symptom questions, answered on a 4-point Likert scale: 1 = not at all to 4 = quite a bit. The mean values of all answered items are multiplied by 25 to determine the scale score (range 0-100). A summary score is also reported (range 0-300). Higher scores denote a greater symptom burden.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Study Director: Keila S Muniz, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04829721
Other Study ID Numbers:
  • IRB00236091
First Posted:
Apr 2, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022