Urinary IncontinenceBHmAppNCT04074044
Evaluation of a New Bladder Health Mobile Application in Pregnancy
A study testing BHmApp in people with Urinary Incontinence, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- BHmApp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women age 18 years or older at 10-18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospitals
Royal Oak, Michigan, 48073
About this study
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.
Read the detailed description
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:
- BHmApp focus is the prevention of UI. Currently, there are many mApps that teach PFMT to treat UI, most use simple instruction protocols, use the same protocol for all patients, and end up working the same way as simple verbal instruction. This BHmApp protocol is designed for pregnant women, offering training for PFMT, Knack, BT and urge suppression and bladder health strategies, allows women to connect with a bladder health coach to ask questions, offers notification reminders of exercise time, and a way for women to record and track adherence to PFMT.
- The BHmApp is built specifically for pregnant women. With pregnancy being the high-risk time in a woman's life to develop UI, there is a need for a UI prevention program that can reach large numbers of women at low cost. The BHmApp is designed to teach pregnant women these new habits and skills, and offers a new opportunity in the effort to prevent UI. This BHmApp takes into consideration the physiologic changes in a woman's body during pregnancy, and the restrictions to certain exercises and habits during pregnancy. For example, bladder health is not practiced until 4 weeks after delivery and PFMT is done in sitting position after 20-weeks gestation.
- 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:
- Complete demographics questionnaire (name, medical Record Number (MRN), email address, Tel. No. Cell Phone Carrier)
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - measures UI frequency, severity, and impact on Quality of Life (QOL)
- Download the Bladder Health Mobile Application (BHmApp) on phone 4 Weeks after BHmApp Download or at End of App Lessons:
- Complete the Patient Education Materials Assessment Tool (PEMAT) - (about 22-24 weeks gestation) - a scoring questionnaire to assess understandability and actionability for audiovisual or printed patient education materials. 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 Pelvic Floor Muscle Training (PFMT) adherence questionnaire
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) 6 Weeks Postpartum Email/Text Sent
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
- Complete Pelvic Floor Muscle Training (PFMT) adherence questionnaire and Bladder Training (BT) adherence questionnaire 12 weeks Postpartum Email/Text Sent
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
- Complete Pelvic Floor Muscle Training (PFMT) adherence questionnaire and Bladder Training (BT) adherence questionnaire 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
- Conditions
- Urinary Incontinence
- Being tested
- BHmApp
- Keywords
- Prevention, Pregnancy, Mobile Health App, PEMAT questionnaire
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHmAppBehavioural
Use of BHmApp for bladder education and training in pregnancy
| Study group | Role | What they receive |
|---|---|---|
| BHmApp users | Experimental | Participants using BHmApp tor bladder education and training Receives: Behavioral: BHmApp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks after enrollment
Secondary outcomes (18)
Recruitment Success
Percentage of patients enrolled of all those approached for study
Measured: At enrollment
Retention rate
Number of participants who remain enrolled in the study through 12 weeks postpartum.
Measured: 12 weeks postpartum
Data completion rate
Number of participants who return completed study questionnaire 12 weeks post partum
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start20 Apr 2023
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open label evaluation
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Elie Mulhem, Corewell Health East
- Investigators
- Elie Mulhem, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074044
- Sponsor's protocol ID
- 2019-157
- Acronym
- BHmApp
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No pan to share individual patient data
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Bladder Health Mobile Application in Pregnancy
- ClinicalTrials.gov ID
- NCT04074044
- Acronym / sponsor ID
- BHmApp / 2019-157
- Conditions
- Urinary Incontinence
- Keywords
- Prevention, Pregnancy, Mobile Health App, PEMAT questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- BHmApp focus is the prevention of UI. Currently, there are many mApps that teach PFMT to treat UI, most use simple instruction protocols, use the same protocol for all patients, and end up working the same way as simple verbal instruction. This BHmApp protocol is designed for pregnant women, offering training for PFMT, Knack, BT and urge suppression and bladder health strategies, allows women to connect with a bladder health coach to ask questions, offers notification reminders of exercise time, and a way for women to record and track adherence to PFMT.
- The BHmApp is built specifically for pregnant women. With pregnancy being the high-risk time in a woman's life to develop UI, there is a need for a UI prevention program that can reach large numbers of women at low cost. The BHmApp is designed to teach pregnant women these new habits and skills, and offers a new opportunity in the effort to prevent UI. This BHmApp takes into consideration the physiologic changes in a woman's body during pregnancy, and the restrictions to certain exercises and habits during pregnancy. For example, bladder health is not practiced until 4 weeks after delivery and PFMT is done in sitting position after 20-weeks gestation.
- 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:
- Complete demographics questionnaire (name, medical Record Number (MRN), email address, Tel. No. Cell Phone Carrier)
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - measures UI frequency, severity, and impact on Quality of Life (QOL)
- Download the Bladder Health Mobile Application (BHmApp) on phone 4 Weeks after BHmApp Download or at End of App Lessons:
- Complete the Patient Education Materials Assessment Tool (PEMAT) - (about 22-24 weeks gestation) - a scoring questionnaire to assess understandability and actionability for audiovisual or printed patient education materials. 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 Pelvic Floor Muscle Training (PFMT) adherence questionnaire
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) 6 Weeks Postpartum Email/Text Sent
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
- Complete Pelvic Floor Muscle Training (PFMT) adherence questionnaire and Bladder Training (BT) adherence questionnaire 12 weeks Postpartum Email/Text Sent
- Complete International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
- Complete Pelvic Floor Muscle Training (PFMT) adherence questionnaire and Bladder Training (BT) adherence questionnaire 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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open label evaluation
| Arm | Type | Receives |
|---|---|---|
| BHmApp users | Experimental | Behavioral: BHmAppParticipants using BHmApp tor bladder education and training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women age 18 years or older at 10-18 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHmAppUse of BHmApp for bladder education and training in pregnancy | Behavioural | BHmApp users |
Primary outcome
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.
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.
18 secondary outcomes
Recruitment Success
Time frame: At enrollment
Retention rate
Time frame: 12 weeks postpartum
Data completion rate
Time frame: 12 weeks post partum
Urinary Incontinence (UI) rate - baseline
Time frame: at enrollment
Urinary Incontinence (UI) rate - 34-36 weeks gestation
Time frame: 34-36 weeks gestation
Urinary Incontinence (UI) rate - 6 weeks postpartum
Time frame: 6 weeks post partum
Urinary Incontinence (UI) rate - 12 weeks postpartum
Time frame: 12 weeks post partum
Adherence to Pelvic Floor Muscle Training (PFMT) - 26-28 weeks gestation
Time frame: 26-28 weeks gestation
Adherence to Pelvic Floor Muscle Training (PFMT) - 30-32 weeks gestation
Time frame: 30-32 weeks gestation
Adherence to Pelvic Floor Muscle Training (PFMT) - 34-36 weeks gestation
Time frame: 34-36 weeks gestation
Adherence to Pelvic Floor Muscle Training (PFMT) - 6 weeks postpartum
Time frame: 6 weeks postpartum
Adherence to Pelvic Floor Muscle Training (PFMT) - 12 weeks postpartum
Time frame: 12 weeks postpartum
Bladder Training Adherence - 6 weeks postpartum
Time frame: 6 weeks post partum
Bladder Training Adherence - 12 weeks postpartum
Time frame: 12 weeks post partum
Voiding interval - 6 weeks postpartum
Time frame: 6 weeks post partum
Voiding interval - 12 weeks postpartum
Time frame: 12 weeks post partum
Barriers to Use of bladder training - 6 weeks postpartum
Time frame: 6 weeks post partum
Barriers to Use of bladder training - 12 weeks postpartum
Time frame: 12 weeks post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. No pan to share individual patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elie Mulhem, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BHmApp in people with Urinary Incontinence, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understandability score from Patient Education Materials Assessment Tool (PMAT) questionnaire (time frame: 4 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.