Training for Urinary Leakage Improvement After Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNICHD Pelvic Floor Disorders Network
About this trial
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 criteria
Qualifiers
≥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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Interventionist-guided training
- Home pelvic floor exercises guided by the leva® device
- Education
Treatment groups
216 Participants
are divided into 3 treatment groupsSponsors and collaborators
NICHD Pelvic Floor Disorders Network
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Duke University
Collaborator
Kaiser Permanente
Collaborator
University of California, San Diego
Collaborator
University of Chicago
Collaborator
University of Pennsylvania
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Women and Infants Hospital of Rhode Island
Collaborator
RTI International
Collaborator
Source ClinicalTrials.gov