Training for Urinary Leakage Improvement After Pregnancy

NARecruitingINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

November 12, 2024

Primary Completion Date

November 12, 2027

Study Completion Date

November 12, 2027

Conditions
Urinary IncontinenceDelivery Complication
Interventions
OTHER

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.

DEVICE

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.

OTHER

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.

Trial Locations (7)

19104

RECRUITING

University of Pennsylvania, Philadelphia

27707

RECRUITING

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham

60637

RECRUITING

University of Chicago, Chicago

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

92110

NOT_YET_RECRUITING

Kaiser Permanente -- San Diego, San Diego

92121

RECRUITING

University of California - San Diego, San Diego

02903

RECRUITING

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Duke University

OTHER

collaborator

Kaiser Permanente

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

University of Chicago

OTHER

collaborator

University of Pennsylvania

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

Women and Infants Hospital of Rhode Island

OTHER

collaborator

RTI International

OTHER

lead

NICHD Pelvic Floor Disorders Network

NETWORK

NCT06411158 - Training for Urinary Leakage Improvement After Pregnancy | Biotech Hunter | Biotech Hunter