Training for Urinary Leakage Improvement After Pregnancy (TULIP)

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Delivery Complication
• Intervention / Treatment: Other: Education; Other: Interventionist-guided training; Device: Home pelvic floor exercises guided by the leva® device

Detailed Description

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) sessions with a skilled interventionist. Arm 2 uses a home biofeedback device (leva®).

All groups will have access to basic education on stress urinary incontinence, overactive bladder, pelvic floor muscle function and continence mechanisms.

Arm 1 will consist of interventionist-guided training at baseline (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 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.

Arm 2 will consist of 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 Arm 2 exercise regimen begins at approximately 8 weeks postpartum and continues until 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.

Arm 3 participants will only be provided basic education materials. No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises.

The primary outcome is change in UI as measured by the ICIQ-SF, comparing scores from baseline to 6 months postpartum. The questionnaire will be sent to participants monthly from baseline through 12 months postpartum, and change through 12 months postpartum is a secondary outcome.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • University of California - San Diego
      • Principal Investigator: Emily Lukacz, MD
      • Contact: Kyle Herrala; Phone Number: 858-657-6827; Email: UrogynRSCH@ucsd.edu
    • San Diego, California, United States, 92110
      • Recruiting
      • Kaiser Permanente -- San Diego
      • Principal Investigator: Shawn A Menefee, MD
      • Contact: Linda Mackinnon; Phone Number: 619-821-6009; Email: linda.m.mackinnon@kp.org
      • Contact: Gisselle Zazueta-Damian; Phone Number: 619-821-5717; Email: gisselle.zazueta-damian@kp.org
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Principal Investigator: Kimberly Kenton, MD
      • Contact: Jinxuan (Rowena) Shi; Phone Number: 872-724-0774; Email: jinxuan.shi@bsd.uchicago.edu
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Recruiting
      • Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
      • Principal Investigator: Nazema Siddiqui, MD
      • Contact: Stephanie Yu; Phone Number: (919) 401-1016; Email: stephanie.yu@duke.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Heidi Harvie, MD
      • Contact: Zandra Kennedy; Phone Number: (215) 615-6569; Email: zandra.kennedy@pennmedicine.upenn.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
      • Principal Investigator: Vivian Sung, MD
      • Contact: Julia Shinnick, MD; Phone Number: (401) 453-7560; Email: jshinnick@wihri.org
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Principal Investigator: David Rahn, MD
      • Contact: Agnes Burris; Phone Number: (214) 645-3833; Email: Agnes.Burris@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary incontinence measure by the ICIQ-SF	The primary outcome is change in urinary incontinence (UI) as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), comparing scores from baseline to 6 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage. ICIQ-SF scores range from 0 (no leakage or bother) to 21 (worst leakage, most bothersome).	From baseline to 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score	Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) is designed to address a broader spectrum of lower urinary tract symptoms, particularly incontinence, bladder pain, and post-micturition symptoms. The LURN-SI-10 score ranges from 0 (least severe) to 38 (most severe).	From baseline to 6 months and 12 months postpartum
Patient Global Impression of Improvement (PGI-I) score	Patient Global Impression of Improvement (PGI-I) captures a participant's perceived improvement from baseline, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse.	At 6 months and 12 months postpartum
Change in St. Mark's score	The St. Mark's questionnaire is used to assess anal incontinence symptom severity. St. Mark's Score, ranges from 0 (perfect fecal continence) to 24 (total fecal incontinence).	From baseline to 6 months and 12 months postpartum
Female Sexual Function Index (FSFI) score	Sexual function will be assessed using the Female Sexual Function Index (FSFI), which uses 19 questions to measure 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Female Sexual Function Index scores range from 2.0 (lowest sexual function) to 36.0 (high sexual function).	At 6 months and 12 months postpartum
Change in urinary incontinence measure by the ICIQ-SF	The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage. ICIQ-SF scores range from 0 (no leakage or bother) to 21 (worst leakage, most bothersome).	From baseline to 12 months postpartum

Collaborators and Investigators

• Sponsor: NICHD Pelvic Floor Disorders Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pennsylvania; University of California, San Diego; University of Chicago; Duke University; University of Texas Southwestern Medical Center; Kaiser Permanente; Women and Infants Hospital of Rhode Island; RTI International
• Investigators: Principal Investigator: Marie Gantz, PhD, RTI International; Principal Investigator: David Rahn, MD, UTSW

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): November 12, 2027

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Physical Therapy; Biofeedback; Urinary Incontinence; Pelvic Floor Disorders; Anal Incontinence
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Signs and Symptoms, Digestive; Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Urinary Incontinence; Pelvic Floor Disorders; Encopresis; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: PFDN-32P01; UG1HD069013 (U.S. NIH Grant/Contract); UG1HD054214 (U.S. NIH Grant/Contract); UG1HD041267 (U.S. NIH Grant/Contract); UG1HD054241 (U.S. NIH Grant/Contract); UG1HD110057 (U.S. NIH Grant/Contract); UG1HD069010 (U.S. NIH Grant/Contract); U24HD069031 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be made available through DASH
• IPD Sharing Time Frame: Plan to submit full study dataset before the end of the award period.
• IPD Sharing Access Criteria: Access is managed by DASH.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No