Training for Urinary Leakage Improvement After Pregnancy

Launched by NICHD PELVIC FLOOR DISORDERS NETWORK · May 7, 2024

Keywords

ClinConnect Summary

The "Training for Urinary Leakage Improvement After Pregnancy" trial is studying how different methods can help new mothers who are experiencing bothersome urinary incontinence (leaking urine) after giving birth. This trial is for women who have recently had their first baby (primiparous) and are at a higher risk for pelvic floor problems due to factors like having a larger baby, needing assistance during delivery, or experiencing severe tearing during childbirth. To participate, women need to be at least 18 years old, have had a vaginal delivery of a healthy baby, and show signs of urinary incontinence.

In this trial, participants will be randomly assigned to one of three groups. Two groups will receive active treatments: one group will engage in pelvic floor muscle training (exercises meant to strengthen the muscles that support the bladder), while the other will use a home biofeedback device to help them track their progress. The third group will receive patient education about urinary incontinence. Participants will be followed for up to a year after giving birth, with the main outcomes assessed at six months postpartum. This trial aims to find out which method works best for improving urinary leakage in new mothers, helping them regain comfort and confidence in their daily lives.

Gender

FEMALE

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 ≥4kg, and/or
• • 2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
• • 3. 3rd or 4th-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)