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Training for Urinary Leakage Improvement After Pregnancy

Recruiting

Who can join

Ages 18 and older · Women

Full eligibility criteria

Inclusion Criteria:

1. ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum
2. At increased risk of sustained pelvic floor disorders, as defined by

   1. neonate ≥3.5kg, and/or
   2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
   3. ≥2nd-degree perineal laceration
3. Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.

Exclusion Criteria:

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

About the study

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.

What is being tested

Interventionist-guided training (other)
Home pelvic floor exercises guided by the leva® device (device)
Education (other)

Sponsor: NICHD Pelvic Floor Disorders Network · Participants: 216 · Started: Nov 12, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06411158

Locations in the U.S.

California	Kaiser Permanente -- San Diego, San Diego University of California - San Diego, San Diego
Illinois	University of Chicago, Chicago
North Carolina	Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham
Pennsylvania	University of Pennsylvania, Philadelphia
Rhode Island	Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence
Texas	University of Texas Southwestern Medical Center, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.