Training for Urinary Leakage Improvement After Pregnancy

NCT06411158 | Recruiting DMC FDA Device

• 8 other identifiers: PFDN-32P01UG1HD069013UG1HD054214UG1HD041267UG1HD054241UG1HD110057UG1HD069010U24HD069031
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 7

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

Delivery Complication; Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score

  From baseline to 6 months and 12 months postpartum

• Patient Global Impression of Improvement (PGI-I) score

  At 6 months and 12 months postpartum

• Change in St. Mark's score

  From baseline to 6 months and 12 months postpartum

• Female Sexual Function Index (FSFI) score

  At 6 months and 12 months postpartum

• Change in urinary incontinence measure by the ICIQ-SF

  From baseline to 12 months postpartum

Study Arms (3)

Interventionist-guided training

ACTIVE COMPARATOR

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

Home pelvic floor exercises guided by the leva® device

ACTIVE COMPARATOR

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

Education

OTHER

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

Interventions

Interventionist-guided training OTHER

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.

Interventionist-guided training

Home pelvic floor exercises guided by the leva® device 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.

Home pelvic floor exercises guided by the leva® device

Education OTHER

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.

Education

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum
• At increased risk of sustained pelvic floor disorders, as defined by
• neonate ≥3.5kg, and/or
• operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
• ≥2nd-degree perineal laceration
• Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.

You may not qualify if:

• Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
• Stillbirth or significant maternal or neonatal illness
• Non-English or non-Spanish speaking
• Perineal wound breakdown or cloaca observed on exam
• Severe pain with assessments of PFM integrity and/or strength/function
• Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
• Unwilling or unable to upload and use external smartphone app(s)

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Duke University: collaborator
• Kaiser Permanente: collaborator
• University of California, San Diego: collaborator
• University of Chicago: collaborator
• University of Pennsylvania: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Women and Infants Hospital of Rhode Island: collaborator
• RTI International: collaborator

Study Sites (7)

Kaiser Permanente -- San Diego

San Diego, California, 92110, United States

RECRUITING

University of California - San Diego

San Diego, California, 92121, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, 27707, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

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

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders; Encopresis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Signs and Symptoms, Digestive; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• David Rahn, MD

  UTSW

  PRINCIPAL INVESTIGATOR

• Marie Gantz, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The primary analyses will use an intention-to-treat (ITT) population to compare change from baseline in ICIQ-SF score at 6 months between treatment groups using a general linear mixed model.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 13, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): November 12, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Plan to submit full study dataset before the end of the award period.
• Access Criteria: Access is managed by DASH.

Locations

US (7)