Improving urinary leakage after pregnancy

Training for Urinary Leakage Improvement After Pregnancy

This study tests whether pelvic floor muscle training or a home biofeedback device can help new moms with urinary leakage after giving birth.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: NICHD Pelvic Floor Disorders Network (network)
• Locations: 7 sites (San Diego, California and 6 other locations)
• Trial ID: NCT06411158 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older who have recently given birth vaginally and are experiencing bothersome urinary incontinence.

Not a fit: Patients who have severe pelvic floor dysfunction or are already engaged in physical therapy for pelvic floor strengthening may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the quality of life for postpartum women suffering from urinary incontinence.

How similar studies have performed: Other studies have shown promise with similar interventions for pelvic floor disorders, indicating potential for success in this approach.

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)

Where this trial is running

San Diego, California and 6 other locations

• 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)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: David Rahn, MD — UTSW

Conditions: Urinary Incontinence, Delivery Complication, Pelvic Floor Disorders, Physical Therapy, Biofeedback, Anal Incontinence