Evaluation of a New Bladder Health Mobile Application in Pregnancy

NCT04074044 | Completed

• 1 other identifier: 2019-157
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Prevention; Pregnancy; Mobile Health App; PEMAT questionnaire

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 weeks after enrollment

Secondary Outcomes (18)

• Recruitment Success

  At enrollment

• Retention rate

  12 weeks postpartum

• Data completion rate

  12 weeks post partum

• Urinary Incontinence (UI) rate - baseline

  at enrollment

• Urinary Incontinence (UI) rate - 34-36 weeks gestation

  34-36 weeks gestation

Study Arms (1)

BHmApp users

EXPERIMENTAL

Participants using BHmApp tor bladder education and training

Behavioral: BHmApp

Interventions

BHmApp BEHAVIORAL

Use of BHmApp for bladder education and training in pregnancy

BHmApp users

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead
• University of Pennsylvania: collaborator

Study Sites (1)

William Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elie Mulhem, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Department of Family Medicine and Community Health

Model Details: Single group, open label evaluation

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: April 20, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)