Training for Urinary Leakage Improvement After Pregnancy

Summary

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

Interventions

OTHER

Interventionist-guided training

Interventionist-guided training at baseline (i.e., approximately 6 weeks postpartum), followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session approximately 4 weeks later, and then continued HEP. Two exercise sets per day are encouraged between baseline and 6 months postpartum (i.e., time of the primary outcome), followed by at least 3 times-per-week exercise sets until 12 months postpartum. Home exercises will be encouraged using a PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.

DEVICE

Home pelvic floor exercises guided by the leva® device

Home pelvic floor exercises guided by the leva® device and its accompanying app/software for gradually increasing strength and duration of pelvic floor contractions. Between baseline and 6 months postpartum, twice-daily exercise sets will be encouraged, followed by at least 3 times-per-week exercises from 6 to 12 months postpartum. As in Arm 1, the PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.

OTHER

Education

Education will be provided on pelvic floor muscle function and continence mechanisms. No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Duke University

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Women and Infants Hospital of Rhode Island

  collaborator OTHER

• RTI International

  collaborator OTHER

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• David Rahn, MD · UTSW

• Marie Gantz, PhD · RTI International

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-12

Primary Completion

2027-05-12

Completion

2027-11-12

FDA Device

Yes

Countries

• United States

Study Locations