RecruitingNot ApplicableNCT06411158

Training for Urinary Leakage Improvement After Pregnancy

Sponsor

NICHD Pelvic Floor Disorders Network

Enrollment

216 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Urinary Incontinence Delivery Complication

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum
At increased risk of sustained pelvic floor disorders, as defined by
neonate ≥3.5kg, and/or
operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
≥2nd-degree perineal laceration
Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.

Exclusion Criteria7

Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
Stillbirth or significant maternal or neonatal illness
Non-English or non-Spanish speaking
Perineal wound breakdown or cloaca observed on exam
Severe pain with assessments of PFM integrity and/or strength/function
Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
Unwilling or unable to upload and use external smartphone app(s)

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Interventions

OTHERInterventionist-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.

DEVICEHome 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.

OTHEREducation

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.