Training for Urinary Leakage Improvement After Pregnancy (TULIP)

This study, called TULIP, is for women who have recently given birth and are experiencing bothersome urinary leakage (urinary incontinence). It aims to see if different types of training can help improve this condition. You might receive training sessions with an expert, or use a home device called leva® for pelvic floor exercises, or receive general education about pelvic floor muscles. Researchers will measure your urinary leakage using a special questionnaire (ICIQ-SF) to see which approach works best. To join, you must be at least 18 years old, have had your first baby vaginally, and be about 6 weeks postpartum. You also need to be at higher risk for pelvic floor problems, such as having a larger baby, an assisted delivery (forceps or vacuum), or a significant tear during birth.

Study design
This is a multi-center, randomized study involving about 216 women. Participants will be assigned to one of three groups: interventionist-guided training, home exercises with the leva® device, or education.
What's involved
You would start around 6-8 weeks postpartum and continue exercises until 12 months postpartum. This includes training sessions, home exercises, and follow-up assessments.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be assessed at 6 months postpartum, and follow-up will continue until 12 months postpartum.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06411158

Training for Urinary Leakage Improvement After Pregnancy

Recruiting
NAAges 18+InterventionalTreatment
NICHD Pelvic Floor Disorders Network
~216 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:Interventionist-guided trainingHome pelvic floor exercises guided by the leva® deviceEducation

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in urinary incontinence measure by the ICIQ-SF
Measured over From baseline to 6 months postpartum
Urinary Incontinence
Delivery Complication
7 sites across 6 states
California2
Illinois1
North Carolina1
Pennsylvania1
Rhode Island1
Texas1
  • David Rahn, MD · PRINCIPAL_INVESTIGATOR · UTSW
  • Marie Gantz, PhD · PRINCIPAL_INVESTIGATOR · RTI International

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  • Change in urinary incontinence measure by the ICIQ-SFFrom baseline to 6 months postpartum

    The primary outcome is change in urinary incontinence (UI) as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), comparing scores from baseline to 6 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage. ICIQ-SF scores range from 0 (no leakage or bother) to 21 (worst leakage, most bothersome).