← Back to Search

Bladder Health App for Urinary Incontinence in Pregnancy (BHmApp Trial)

N/A

Recruiting

Led By Elie Mulhem, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant women age 18 years or older at 10-18 weeks gestation

Negative history or no more than 5 episodes of UI in the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at enrollment

Awards & highlights

BHmApp Trial Summary

This trial will test a mobile health application that teaches pregnant women new habits and exercises to keep their bladder healthy and decrease the risk of urinary incontinence during pregnancy.

Who is the study for?

This trial is for English-speaking pregnant women, aged 18 or older, who are 10-18 weeks along with a low-risk single pregnancy. They should have experienced minimal urinary incontinence in the past year and own a smartphone. Women with high-risk pregnancies or previous UI treatments are excluded.Check my eligibility

What is being tested?

The study tests a Bladder Health Mobile Application (BHmApp) designed to teach pregnant women exercises and habits to maintain bladder health and reduce urinary incontinence risk during pregnancy.See study design

What are the potential side effects?

Since BHmApp involves educational content and exercises, there may be minimal side effects related to app usage such as eye strain from screen time or discomfort from new physical exercises.

BHmApp Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant, over 18, and between 10-18 weeks along.

Select...

I have had 5 or fewer episodes of urinary incontinence in the last year.

Select...

I do not have any muscle, nerve, or bladder conditions.

BHmApp Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Actionability score from Patient Education Materials Assessment Tool (PMAT) questionnaire

Understandability score from Patient Education Materials Assessment Tool (PMAT) questionnaire

Secondary outcome measures

Adherence to Pelvic Floor Muscle Training (PFMT) - 12 weeks postpartum

Muscle Tissue

Adherence to Pelvic Floor Muscle Training (PFMT) - 30-32 weeks gestation

+15 more

BHmApp Trial Design

1Treatment groups

Experimental Treatment

Group I: BHmApp usersExperimental Treatment1 Intervention

Participants using BHmApp tor bladder education and training

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER

2,000 Previous Clinical Trials

42,880,028 Total Patients Enrolled

7 Trials studying Urinary Incontinence

1,723 Patients Enrolled for Urinary Incontinence

William Beaumont HospitalsLead Sponsor

149 Previous Clinical Trials

112,798 Total Patients Enrolled

10 Trials studying Urinary Incontinence

1,031 Patients Enrolled for Urinary Incontinence

Elie Mulhem, MDPrincipal Investigator - William Beaumont Hospitals

Beaumont Hospital-Grosse Pointe, Beaumont Hospital-Royal Oak, Beaumont Hospital-Troy, William Beaumont Hospital

Media Library

BHmApp Clinical Trial Eligibility Overview. Trial Name: NCT04074044 — N/A

Urinary Incontinence Research Study Groups: BHmApp users

Urinary Incontinence Clinical Trial 2023: BHmApp Highlights & Side Effects. Trial Name: NCT04074044 — N/A

BHmApp 2023 Treatment Timeline for Medical Study. Trial Name: NCT04074044 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment capacity for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical research project, which was first advertised on January 1st 2023, is still enrolling patients. 30 volunteers are required from a single location for the study's completion."

Answered by AI

What is the overarching goal of this exploratory research?

"The primary objective of this research endeavour, which will be monitored for up to 4 weeks post-enrollment, is to assess the Actionability score from the Patient Education Materials Assessment Tool (PMAT) questionnaire. Secondary outcomes focus on Urinary Incontinence (UI), Voiding Interval twelve weeks after childbirth, and overall Data Completion rate at 12 week followup. UI severity is quantified using a three question International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF): 1-5 denotes mild incontinence; 6-12 denotes moderate incontinence; 13-18 implies severe incontin"

Answered by AI

Are there any current openings for participants in this experiment?

"Affirmative. The clinical trial database on clinicialtrials.gov reveals that recruitment for this study has commenced, with the initial posting of the trial taking place on January 1st 2023 and being last updated on November 16th 2022. Currently, 30 patients are sought across one medical site."

Answered by AI

To what extent is participation in this trial open to all individuals?

"This medical study is searching for 30 candidates aged between 18-45 that suffer from urinary incontinence and meet the additional prerequisites of: being pregnant (16-20 weeks), having a basic understanding of English, no more than 5 UI episodes over the prior year, lack any neuromuscular or genitourinary issues; low risk antepartum status; singleton pregnancy; and owning a smartphone."

Answered by AI