Self-Care to Prevent Birth-Related Urinary Incontinence in Diverse Women

NCT00763984 | Completed Phase 3 DMC

• 4 other identifiers: 2R01NR007618-06A12R01NR007618HUM00015712NCT00763984
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 3

Brief Summary

The primary goal of this project is to determine the efficacy of an antenatal Bladder Health class to prevent UI in a diverse sample of African American, Caucasian, and Hispanic childbearing women. The determination of efficacy will be made at 12-months post index birth, a time point that is a traditional benchmark of recovery from childbirth, using UI incidence/severity as the primary outcome.

Conditions

Urinary Incontinence

Keywords

Bladder Control for Women; Exercising Your Pelvic Muscles; Kegel Exercises: How to Strengthen Pelvic Floor Muscles; Kegel Exercises for Your Pelvic Muscles; Pelvic Floor Disorders; Pelvic Support Problems; Pregnancy; Pregnancy Childbirth and Bladder Control; Urinary Incontinence; Urinary Incontinence: Embarrassing but Treatable

Outcome Measures

Primary Outcomes (1)

• UI incidence/severity

  12 months - 3 years post-index birth

Study Arms (2)

1 Usual Care

ACTIVE COMPARATOR

This group will receive routine care, however, it is possible that that control condition participants will receive Pelvic Floor Muscle Training (PFMT) instruction from their health care providers. We will monitor control women's knowledge, adoption and maintaining of PFMT

Behavioral: Usual Care

2 Bladder Health Class

EXPERIMENTAL

Modeled on our intervention with older women, Bladder Health Class (BH Class) will include Pelvic floor muscle training (PFMT), defined by the International Continence Society as repetitive selective voluntary contraction and relaxation of specific pelvic floor muscles, and bladder training (BT), defined as a program of scheduled voiding with gradually progressive voiding intervals. The BT instructions will be modified for this pregnant group. We will monitor control women's knowledge, adoption and maintaining of PFMT and BT.

Behavioral: Bladder Health class

Interventions

Usual Care BEHAVIORAL

This group will receive routine care, however, it is possible that that control condition participants will receive Pelvic Floor Muscle Training (PFMT) instruction from their health care providers. We will monitor control women's knowledge, adoption and maintaining of PFMT.

1 Usual Care

Bladder Health class BEHAVIORAL

Modeled on our intervention with older women, Bladder Health Class (BH Class) will include Pelvic floor muscle training (PFMT), defined by the International Continence Society as repetitive selective voluntary contraction and relaxation of specific pelvic floor muscles, and bladder training (BT), defined as a program of scheduled voiding with gradually progressive voiding intervals. The BT instructions will be modified for this pregnant group. We will monitor control women's knowledge, adoption and maintaining of PFMT and BT.

2 Bladder Health Class

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are pregnant and expecting their first, second, or third baby are eligible if they:
• are age eighteen years or older
• are able to understand and read English or Spanish
• are low risk antepartum (first, second or third pregnancy)
• are 16-25 weeks pregnant
• expect a vaginal birth
• have lost no more than a few drops of urine as often as every other day
• have no previous or current urinary incontinence treatment with medication, formal behavioral programs or surgery
• have no history of bladder cancer, diabetes, stroke, multiple sclerosis, muscular dystrophy, cerebral palsy, Parkinson's, epilepsy, or trauma of the spinal cord
• Do not have (or have not had within the last 3 years) \*chronic urinary tract infection. \*Chronic is defined as having more than 3 urinary tract infections in one year.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Jackson Center for Family Health

Jackson, Michigan, 49202, United States

Location

La Clinica de la Santa Teresa

Pontiac, Michigan, 48341, United States

Location

Related Publications (1)

• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

  PMID: 32378735 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders

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; Pregnancy Complications

Study Officials

• Carolyn Sampselle, PhD RNC FAAN

  University of Michigan, School of Nursing, Grants and Research Office

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carolyne K. Davis Professor of Nursing

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

US (3)