216
Participants
Start Date
November 12, 2024
Primary Completion Date
November 12, 2027
Study Completion Date
November 12, 2027
Interventionist-guided training
Interventionist-guided training at baseline (i.e., approximately 6 weeks postpartum), followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session approximately 4 weeks later, and then continued HEP. Two exercise sets per day are encouraged between baseline and 6 months postpartum (i.e., time of the primary outcome), followed by at least 3 times-per-week exercise sets until 12 months postpartum. Home exercises will be encouraged using a PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.
Home pelvic floor exercises guided by the leva® device
Home pelvic floor exercises guided by the leva® device and its accompanying app/software for gradually increasing strength and duration of pelvic floor contractions. Between baseline and 6 months postpartum, twice-daily exercise sets will be encouraged, followed by at least 3 times-per-week exercises from 6 to 12 months postpartum. As in Arm 1, the PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.
Education
Education will be provided on pelvic floor muscle function and continence mechanisms. No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises.
RECRUITING
University of Pennsylvania, Philadelphia
RECRUITING
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham
RECRUITING
University of Chicago, Chicago
RECRUITING
University of Texas Southwestern Medical Center, Dallas
NOT_YET_RECRUITING
Kaiser Permanente -- San Diego, San Diego
RECRUITING
University of California - San Diego, San Diego
RECRUITING
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence
Collaborators (1)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Duke University
OTHER
Kaiser Permanente
OTHER
University of California, San Diego
OTHER
University of Chicago
OTHER
University of Pennsylvania
OTHER
University of Texas Southwestern Medical Center
OTHER
Women and Infants Hospital of Rhode Island
OTHER
RTI International
OTHER
NICHD Pelvic Floor Disorders Network
NETWORK