Training for Urinary Leakage Improvement After Pregnancy

Description

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.

Conditions

Urinary Incontinence, Delivery Complication

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Study Overview

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Study Details

Study overview

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.

Training for Urinary Leakage Improvement After Pregnancy

Training for Urinary Leakage Improvement After Pregnancy

Condition
Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

San Diego

Kaiser Permanente -- San Diego, San Diego, California, United States, 92110

San Diego

University of California - San Diego, San Diego, California, United States, 92121

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Durham

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham, North Carolina, United States, 27707

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Providence

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence, Rhode Island, United States, 02903

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NICHD Pelvic Floor Disorders Network,

David Rahn, MD, PRINCIPAL_INVESTIGATOR, UTSW

Marie Gantz, PhD, PRINCIPAL_INVESTIGATOR, RTI International

Study Record Dates

2027-11-12