Improving urinary leakage after pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, randomized trial focuses on primiparous postpartum women at high risk for pelvic floor disorders and bothersome urinary incontinence. Participants are divided into three groups: one receiving pelvic floor muscle training, another using a home biofeedback device, and a control group receiving basic education. The primary outcome will be evaluated at 6 months postpartum, with follow-up extending to 12 months. The study aims to assess the effectiveness of these interventions in improving urinary incontinence symptoms.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: David Rahn, MD — Utsw

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.