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Evaluation of a New Bladder Health Mobile Application in Pregnancy (BHmApp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074044
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Elie Mulhem, William Beaumont Hospitals

Brief Summary:
Millions of women experience involuntary loss of urine called urinary incontinence (UI). UI can be slightly bothersome or totally debilitating. Women experience UI twice as often as men. Urinary incontinence can also be a persistent condition caused by underlying physical problems or changes, including pregnancy and childbirth. UI symptom severity progress dynamically and are also sustained over time. High quality evidence shows that pelvic floor muscle training (PFMT) during pregnancy effectively reduces the risk of UI during pregnancy and the postpartum period. There is a critical need for a low cost and easily accessible program to prevent UI in pregnancy and postpartum that can reach a large number of women. A mobile health application that teaches UI preventive program during pregnancy has the potential of being a cost effective tool to reach a large number of pregnant women. The Bladder Health Mobile Application (BHmApp) will teach pregnant women new habits and exercises that will keep their bladder healthy during pregnancy and decrease the risk of UI during this period of a woman's life that is considered high risk for developing UI. In this pilot study, it is proposed to evaluate the understand and effectively use the BHmApp, and the feasibility of using the BHmApp during pregnancy.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Behavioral: BHmApp Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group, open label evaluation
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a New Bladder Health Mobile Application in Pregnancy
Estimated Study Start Date : August 30, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BHmApp users
Participants using BHmApp tor bladder education and training
Behavioral: BHmApp
Use of BHmApp for bladder education and training in pregnancy




Primary Outcome Measures :
  1. Understandability score from Patient Education Materials Assessment Tool (PMAT) questionnaire [ Time Frame: 4 weeks after enrollment ]
    Percentage of positive responses to understandability questions (1-19) of the PMAT survey, where each question has a score of 0=disagree and 1=agree for each question. The sum of total points is divided by the sum of total possible points and multiplied by 100 to get percentage. A high score indicates the participant understood the material well.

  2. Actionability score from Patient Education Materials Assessment Tool (PMAT) questionnaire [ Time Frame: 4 weeks after enrollment ]
    Percentage of positive responses to actionability questions (20-26) of the PMAT survey, where each question has a score of 0=disagree and 1=agree for each question. The sum of total points is divided by the sum of total possible points and multiplied by 100 to get percentage. A high score indicates the participant was able to develop an action plan from the material.


Secondary Outcome Measures :
  1. Recruitment Success [ Time Frame: At enrollment ]
    Percentage of patients enrolled of all those approached for study

  2. Retention rate [ Time Frame: 12 weeks postpartum ]
    Number of participants who remain enrolled in the study through 12 weeks postpartum.

  3. Data completion rate [ Time Frame: 12 weeks post partum ]
    Number of participants who return completed study questionnaire 12 weeks post partum

  4. Urinary Incontinence (UI) rate - baseline [ Time Frame: at enrollment ]
    Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence.

  5. Urinary Incontinence (UI) rate - 34-36 weeks gestation [ Time Frame: 34-36 weeks gestation ]
    Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence.

  6. Urinary Incontinence (UI) rate - 6 weeks postpartum [ Time Frame: 6 weeks post partum ]
    Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence.

  7. Urinary Incontinence (UI) rate - 12 weeks postpartum [ Time Frame: 12 weeks post partum ]
    Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence.

  8. Adherence to Pelvic Floor Muscle Training (PFMT) - 26-28 weeks gestation [ Time Frame: 26-28 weeks gestation ]
    Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises.

  9. Adherence to Pelvic Floor Muscle Training (PFMT) - 30-32 weeks gestation [ Time Frame: 30-32 weeks gestation ]
    Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises.

  10. Adherence to Pelvic Floor Muscle Training (PFMT) - 34-36 weeks gestation [ Time Frame: 34-36 weeks gestation ]
    Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises.

  11. Adherence to Pelvic Floor Muscle Training (PFMT) - 6 weeks postpartum [ Time Frame: 6 weeks postpartum ]
    Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises.

  12. Adherence to Pelvic Floor Muscle Training (PFMT) - 12 weeks postpartum [ Time Frame: 12 weeks postpartum ]
    Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises.

  13. Bladder Training Adherence - 6 weeks postpartum [ Time Frame: 6 weeks post partum ]
    Number of patients indicating "yes" to the bladder training adherence question of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. A positive response indicates bladder training was used.

  14. Bladder Training Adherence - 12 weeks postpartum [ Time Frame: 12 weeks post partum ]
    Number of patients indicating "yes" to the bladder training adherence question of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. A positive response indicates bladder training was used.

  15. Voiding interval - 6 weeks postpartum [ Time Frame: 6 weeks post partum ]
    Change in estimated number of minutes between urinations after completing bladder training, as reported on the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire.

  16. Voiding interval - 12 weeks postpartum [ Time Frame: 12 weeks post partum ]
    Change in estimated number of minutes between urinations after completing bladder training, as reported on the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire.

  17. Barriers to Use of bladder training - 6 weeks postpartum [ Time Frame: 6 weeks post partum ]
    Numbers of patients reporting each of 4 possible reasons as barriers to use of bladder training: Average time between urinations was as recommended, it was too complicated to fit into daily life, it was not a technique the participant wanted to try, or other.

  18. Barriers to Use of bladder training - 12 weeks postpartum [ Time Frame: 12 weeks post partum ]
    Numbers of patients reporting each of 4 possible reasons as barriers to use of bladder training: Average time between urinations was as recommended, it was too complicated to fit into daily life, it was not a technique the participant wanted to try, or other.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women age 18 years or older at 16-20 weeks gestation
  • Ability to understand English
  • Negative history or no more than 5 episodes of UI in the past 12 months
  • Negative history of neuromuscular or genitourinary conditions
  • Low-risk antepartum
  • Singleton pregnancy
  • Owner of a smart phone

Exclusion Criteria:

• High-risk pregnancy, including medical complications during pregnancy, such as preterm delivery, preterm premature rupture of membranes, diabetes, or hypertensive disorders and history of prior diagnosis or treatment (behavioral, drug or surgical) for urinary incontinence


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074044


Contacts
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Contact: Elie Mulhem, MD 248 964-0400 elie.mulhem@beaumont.edu
Contact: Kathleen Bradley, CRCI 248 964-8529 kathleen.bradley@beaumont.org

Locations
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United States, Michigan
William Beaumont Hospitals Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Principal Investigator         
Sponsors and Collaborators
William Beaumont Hospitals
University of Pennsylvania
Investigators
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Principal Investigator: Elie Mulhem, MD William Beaumont Hospitals
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Responsible Party: Elie Mulhem, Vice Chair, Department of Family Medicine and Community Health, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT04074044    
Other Study ID Numbers: 2019-157
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No pan to share individual patient data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elie Mulhem, William Beaumont Hospitals:
Prevention
Pregnancy
Mobile Health App
PEMAT questionnaire
Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms