Recruiting

Urinary LeakageTraining for Urinary Leakage Improvement After Pregnancy

Sponsor:

NICHD Pelvic Floor Disorders Network

Code:

NCT06411158

Conditions

Urinary Incontinence

Delivery Complication

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interventionist-guided training

Home pelvic floor exercises guided by the leva® device

Education

Study Details

Brief 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

Study ID

NCT06411158

Start date

Nov 12, 2024

Status verified date

Dec, 2025

Completion date

Nov 12, 2027

Anticipated

Primary completion date

May 12, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Interventionist-guided training

Interventionist-guided training at baseline (i.e., approximately 8 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.

active comparator: 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. The PFDN research smartphone app will have weekly queries of whether exercises were 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.

Interventions

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.

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.

Education

Primary outcome measure

Change in urinary incontinence measure by the ICIQ-SF [ Time Frame: From baseline to 6 months postpartum ]

Central Contacts and Locations

Locations

Kaiser Permanente -- San Diego

Recruiting

San Diego, California, United States, 92110

Contacts

Gisselle Zazueta-Damian

619-821-5717 gisselle.zazueta-damian@kp.org

Linda Mackinnon

619-821-6009 linda.m.mackinnon@kp.org

Principal Investigator:

Shawn A Menefee, MD

University of California - San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

Kyle Herrala

858-657-6827 UrogynRSCH@ucsd.edu

Principal Investigator:

Emily Lukacz, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jinxuan (Rowena) Shi

872-724-0774 jinxuan.shi@bsd.uchicago.edu

Principal Investigator:

Kimberly Kenton, MD

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Recruiting

Durham, North Carolina, United States, 27707

Contacts

Stephanie Yu

(919) 401-1016 stephanie.yu@duke.edu

Principal Investigator:

Nazema Siddiqui, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Zandra Kennedy

(215) 615-6569 zandra.kennedy@pennmedicine.upenn.edu

Principal Investigator:

Heidi Harvie, MD

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

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Julia Shinnick, MD

(401) 453-7560 jshinnick@wihri.org

Principal Investigator:

Vivian Sung, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Agnes Burris

(214) 645-3833 Agnes.Burris@UTSouthwestern.edu

Principal Investigator:

David Rahn, MD

More Information

Sponsor

NICHD Pelvic Floor Disorders Network

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

Urinary Incontinence
Pelvic Floor Disorders
Physical Therapy
Biofeedback
Anal Incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NICHD Pelvic Floor Disorders Network on 2025-12-31.