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RECRUITING
NCT06411158
NA

Training for Urinary Leakage Improvement After Pregnancy

Sponsor: NICHD Pelvic Floor Disorders Network

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment. TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®). The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2024-11-12

Completion Date

2027-11-12

Last Updated

2025-12-31

Healthy Volunteers

No

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.

Locations (7)

Kaiser Permanente -- San Diego

San Diego, California, United States

University of California - San Diego

San Diego, California, United States

University of Chicago

Chicago, Illinois, United States

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States