RECRUITING

Training for Urinary Leakage Improvement After Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Training for Urinary Leakage Improvement After Pregnancy

Quick Facts

Study Start:2024-11-12
Study Completion:2027-11-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06411158

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum
  2. 2. At increased risk of sustained pelvic floor disorders, as defined by
  3. 1. neonate ≥4kg, and/or
  4. 2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
  5. 3. 3rd or 4th-degree perineal laceration
  6. 3. Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.
  1. 1. Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
  2. 2. Stillbirth or significant maternal or neonatal illness
  3. 3. Non-English or non-Spanish speaking
  4. 4. Perineal wound breakdown or cloaca observed on exam
  5. 5. Severe pain with assessments of PFM integrity and/or strength/function
  6. 6. Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
  7. 7. Unwilling or unable to upload and use external smartphone app(s)

Contacts and Locations

Principal Investigator

David Rahn, MD
PRINCIPAL_INVESTIGATOR
UTSW
Marie Gantz, PhD
PRINCIPAL_INVESTIGATOR
RTI International

Study Locations (Sites)

Kaiser Permanente -- San Diego
San Diego, California, 92110
United States
University of California - San Diego
San Diego, California, 92121
United States
University of Chicago
Chicago, Illinois, 60637
United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, 02903
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: NICHD Pelvic Floor Disorders Network

  • David Rahn, MD, PRINCIPAL_INVESTIGATOR, UTSW
  • Marie Gantz, PhD, PRINCIPAL_INVESTIGATOR, RTI International

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12
Study Completion Date2027-11-12

Study Record Updates

Study Start Date2024-11-12
Study Completion Date2027-11-12

Terms related to this study

Keywords Provided by Researchers

  • Urinary Incontinence
  • Pelvic Floor Disorders
  • Physical Therapy
  • Biofeedback
  • Anal Incontinence

Additional Relevant MeSH Terms

  • Urinary Incontinence
  • Delivery Complication