An interventional study of BHmApp in Urinary Incontinence, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Prevention
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.
Urinary incontinence (UI) is the involuntary and unintentional leaking of urine. Over 20 million of women experience UI, approximately 34% (range 25-45%) of all US women are affected indicating a significant healthcare concern with both financial and quality of life implications. The financial cost of UI in the United States (U.S) exceeds $65 billion per year (in year 2007 dollars), and it is projected that the cost will be $82.6 billion in 2020.Women with UI feel shame about this condition, report poor self-esteem, and are at increased risk of depression. Pregnancy is a high-risk time for developing stress UI, urine leakage with physical effort, with a reported prevalence of 35-67% during pregnancy and 31% postpartum. Pregnancy also places women at increased risk of developing UI later in life.
High quality evidence shows that pelvic floor muscle training (PFMT) during pregnancy effectively reduces the risk of UI during pregnancy and the postpartum period by 39-59%. A recent Cochrane review examined the evidence for PFMT based on 38 trials involving 9,892 women from 20 countries. The authors concluded that in continent pregnant women, performing antenatal PFMT may decrease the risk of UI in late pregnancy and in the mid-postnatal period greater 3 to six months postpartum. However, evidence shows that many women in the U.S. do not receive effective PFMT. PFMT to prevent UI is not routinely offered or well taught to pregnant women.
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. Such a program could reduce the financial and psychological impact of UI on pregnant women, lower the risk of UI with its associated negative outcomes and address a priority area identified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). 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 plan is to offer PFMT, the Knack (squeeze before you sneeze trick), bladder training (BT) with urge suppression and healthy bladder education (fluid modification, bowel habits) using a mobile health application that allows women to learn and practice these new habits anytime and anywhere that is convenient to them. In the pilot studies, as supported by other studies, it was learned that the main obstacles to preventing UI by means of PFMT are the feasibility of group classes and low adherence to the exercise routine. Mobile health application (mApp) offers an innovative approach to improve feasibility. PFMT mApps showed effectiveness in women with stress UI and improved adherence to PFMT in women with UI. Additionally, stress UI self-management that includes PFMT with mApp has been shown to be cost-effective. Measurement of adherence to behavioral protocols has often been overlooked in research. Few studies provide information about how adherent women were with PFMT and the literature is sparse on methods to identify barriers and improve adherence. Adherence to PFM exercises during pregnancy was reported to be between 16%-69%, and adherence rates 4-6 weeks after delivery were 43%-83%. Common reasons for not doing PFMT during pregnancy and postpartum include exercises are: forgetting, being too busy, and the belief they have become unnecessary due to the absence of symptoms. Using a mobile App is an innovative way to address these obstacles. To help women overcome these particular barriers, this study proposes a Bladder Health mobile application (BHmApp) that will use various forms of reminders, provide exercise aids, link daily exercises to environmental cues, and integrate exercises into the patient's everyday activities.
To support adherence, the BHmAPP will communicate realistic expectations, make it clear that it may take weeks to months for symptom improvement, and it may be irregular, with "good" days and "bad" days. The BHmApp can provide support by tracking and reinforcing progress, identifying and addressing barriers, and encouraging persistence.
During the last year, the team worked on designing and building the BHmApp aimed to 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 ability to comprehend the tool and take appropriate actions using the BHmApp, and the feasibility of using the BHmApp during pregnancy.
The BHmApp is designed to: effectively engage pregnant women prior to development of UI and associated bladder symptoms, teach them new health habits that will decrease their risk of UI and associated bladder symptoms and increase their ability to keep their bladder healthy. The proposed project is innovative in the following ways:
The BHmApp format allows participants to access the health information at any time, and anywhere that is convenient for them. Pregnancy is a busy period of time in a woman's life, with increased healthcare visits, preparing for new baby, and an increased chance of fatigue and insomnia. Offering a chance to gain new knowledge and learn new habits through short (2-3 minutes) lessons, that can be accessed at a woman's convenience, would significantly increase the chances of learning these important skills and habits during pregnancy.
Participants will complete the following study activities:
Study Initiation:
Download the Bladder Health Mobile Application (BHmApp) on phone
4 Weeks after BHmApp Download or at End of App Lessons:
26-28 Weeks Gestation Email/Text Sent • Complete Pelvic Floor Muscle Training (PFMT) adherence questionnaire
30-32 Weeks Gestation Email/Text Sent • Complete Pelvic Floor Muscle Training (PFMT) adherence questionnaire
34-36 Weeks Gestation Email/Text Sent
Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
6 Weeks Postpartum Email/Text Sent
Complete Pelvic Floor Muscle Training (PFMT) adherence questionnaire and Bladder Training (BT) adherence questionnaire
12 weeks Postpartum Email/Text Sent
The BHmApp is 2-4 minutes in length with separate quick and slow exercises. Soft music is played through the entire recording with the sound slightly increasing during the relaxation period. The work-out music is motivational but not too fast.
The app contains 3 audio lessons:
Lesson 1, the quick squeeze Lesson 2, the slow squeeze Lesson 3, practice a full set of a pelvic muscle exercises including the quick squeeze and slow squeeze
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's enrollment of 50 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
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Exclusion Criteria:
Participants using BHmApp tor bladder education and training
Behavioral: BHmApp
Use of BHmApp for bladder education and training in pregnancy
Understandability score from Patient Education Materials Assessment Tool (PMAT) questionnaire
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.
Time frame: 4 weeks after enrollment
Actionability score from Patient Education Materials Assessment Tool (PMAT) questionnaire
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.
Time frame: 4 weeks after enrollment
Recruitment Success
Percentage of patients enrolled of all those approached for study
Time frame: At enrollment
Retention rate
Number of participants who remain enrolled in the study through 12 weeks postpartum.
Time frame: 12 weeks postpartum
Data completion rate
Number of participants who return completed study questionnaire 12 weeks post partum
Time frame: 12 weeks post partum
Urinary Incontinence (UI) rate - baseline
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.
Time frame: at enrollment
Urinary Incontinence (UI) rate - 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.
Time frame: 34-36 weeks gestation
Urinary Incontinence (UI) rate - 6 weeks postpartum
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.
Time frame: 6 weeks post partum
Urinary Incontinence (UI) rate - 12 weeks postpartum
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.
Time frame: 12 weeks post partum
Adherence to Pelvic Floor Muscle Training (PFMT) - 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.
Time frame: 26-28 weeks gestation
Adherence to Pelvic Floor Muscle Training (PFMT) - 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.
Time frame: 30-32 weeks gestation
Adherence to Pelvic Floor Muscle Training (PFMT) - 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.
Time frame: 34-36 weeks gestation
Adherence to Pelvic Floor Muscle Training (PFMT) - 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.
Time frame: 6 weeks postpartum
Adherence to Pelvic Floor Muscle Training (PFMT) - 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.
Time frame: 12 weeks postpartum
Bladder Training Adherence - 6 weeks postpartum
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.
Time frame: 6 weeks post partum
Bladder Training Adherence - 12 weeks postpartum
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.
Time frame: 12 weeks post partum
Voiding interval - 6 weeks postpartum
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.
Time frame: 6 weeks post partum
Voiding interval - 12 weeks postpartum
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.
Time frame: 12 weeks post partum
Barriers to Use of bladder training - 6 weeks postpartum
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.
Time frame: 6 weeks post partum
Barriers to Use of bladder training - 12 weeks postpartum
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.
Time frame: 12 weeks post partum
Plan to share: No — No pan to share individual patient data
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